Tuesday, September 1, 2015

Top Scientists Address Downstream Processing

Characterization of Host-Cell Proteins Using Mass Spectrometry Enables Effective Purification Optimization

Lin Zang, Senior Scientist, Analytical Development, Biogen describes the mass spectrometry workflow for host cell protein identification that she will be presenting on at the BioProcess International Conference & Exposition, and discusses the implications of HCPs on downstream process development.

Hear more from Lin at 4:00 pm on Wednesday, October 28, 2015 at BPI.

Listen to her interview here: http://bit.ly/1VucXxR



A Novel Approach to Monitor Clearance of Host Cell Proteins Associated with Monoclonal Antibodies 

The big challenge in downstream process development concerning host cell proteins is that the amount of HCPs in the purified product is often so low that it is hard to determine the identity of the HCP. Min Zhu, Senior Scientist, Purification Process Sciences, MedImmune LLC, describes how the approach she will be presenting at the conference overcomes this challenge.

Hear more from Min at 4:30 pm on Wednesday, October 28, 2015 at BPI.

Listen to her interview here: http://bit.ly/1VucXxR



Implementing Multi-Attribute LC/MS Methods for More Informed Process Development 

Matthew Traylor, Analytical Scientist, Process Development, Shire, discusses how he gets a deep characterization a specific protein out of a mixture, using LC/MS software packages that automate the process. He shares how this technology can be used at laboratory, pilot and production scale process development.

Hear more from Matthew at 9:20 am on Tuesday, October 27, 2015 at BPI.

Listen to his interview here: http://bit.ly/1NKYZWY



Continued Process Verification (CPV) Informatics Systems and Validation 

Carly Cox, Senior Process Engineer, Pfizer, describes what a CPV informatics system is and how it’s used in product manufacturing. She’ll be presenting at the BioProcess International Conference on how multiple source systems can pull data on product manufacturing processing and be collected into a CPV informatics system, and some of the important areas to consider for validation and configuration for regulatory reporting and process monitoring.  

Hear more from Carly at 9:20 am on Wednesday, October 28, 2015 at BPI.



Rapid Microbiological Methods for Real-Time Release of Autologous Cell Therapy Products 

Hear about how a risk based approach to autologous cell therapy products used at Vericel. In this podcast, John Duguid, Principal Scientist, Vericel Corporation, describes how rapid microbiological methods are used in product release of autologous cell therapy products, and discusses the areas of contamination risk. Audio Player

Hear more from John at 2:00 pm on Thursday, October 29, 2015 at BPI.

Listen to his interview here: http://bit.ly/1IFdZ0I

If you haven’t already, register for BPI 2015 taking place this fall in Boston. BPI is engineered to be exactly what YOU need it to be. Formal and informal networking experiences connect you to peers, prospects, and customers. Parallel tracks give you the option to dive deep or take a big picture approach to learn about industry trends, challenges, and benchmark against the latest research developments. Big pharma and large, mid-size and emerging biotechs collaborating with solution providers featuring proven and next generation technologies make BPI a one-of-a-kind meeting place.As a valued reader of our blog, you get an exclusive $100 off the current rate when you use code XB15171BLOG. Register here: http://bit.ly/1JA9EQe




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Friday, August 28, 2015

LAST CHANCE | Save $550 to Antibody Engineering & Therapeutics

As the largest and most trusted antibody engineering and therapeutics event in the industry, IBC's Antibody Engineering & Therapeutics continues to showcase an impressive collection of world-renowned and highly-published academic and industry scientists, as they share the latest science, strategies and preclinical/clinical development efforts.

Get a sneak peek at the high caliber sessions and happenings of the event by watching the 2014 event highlights:



By attending this event, you will learn from 120+ speakers and connect with over 700 of your peers to help you discover, engineer and develop novel and next-generation antibody modalities. In addition, you will gain fresh ideas and new perspectives to accelerate your current project by viewing over 100 academic and industry poster presentations covering the latest cutting edge antibody research.

To see full session & speaker details, download the brochure.

But you have to be registered first to get access! Register today to take advantage of the early-bird savings of up to $550. Be sure to use code D15172BLOG. The savings expire tomorrow, Friday, August 28th—so hurry! Register now.



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Thursday, August 27, 2015

Exciting Trends in Bioprocessing

A White Paper Exclusive
By Alfred Doig and Susan Dana Jones, Ph.D., BioProcess Technology Consultants, Inc.
Getting products onto the market as quickly as possible still remains a key driver in the development of recombinant therapeutic proteins. Any advance in bioprocessing is of particular interest to the industry if it significantly shortens the development timeline or improves the end product. Even better are advances that do both. In the monoclonal antibody (MAb) area, platform processes have enabled companies to standardize on specific mammalian cell lines, transfection approaches, process conditions and downstream processing to shorten the development timeframe.
Access an exclusive white paper to read about several interesting trends in two development areas, which have the potential to shorten the development timeline still further.
Does this topic interest you? If so, we invite you to attend the BioProcess International (BPI) Conference & Exhibition, scheduled for October 26-29, 2015, is the world's largest gathering of bioprocessing and biomanufacturing scientists, executives and technology providers, bringing over 1,600 attendees, 150 exhibitors, 160 speakers and 100 posters to Boston—providing the most effective platform to launch or learn about new products, showcase and evaluate new bioprocess technologies, share and receive input on scientific research and meet the industry's leading innovators in bioprocess development.
BPI covers all phases of bioprocess development including upstream, downstream, analytical, formulation, manufacturing, quality/regulatory and drug product/fill-finish.


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Listen to the Cell Culture & Upstream Processing Podcast Series

At BioProcess International Conference & Exposition, the Cell Culture & Upstream Processing track will feature process development scientists, engineers and technical experts sharing their recent achievements in reducing timelines and cost of goods while increasing efficiency and productivity through implementation of disruptive approaches and technologies.

Today, BPI is recognized as the leading bioprocessing industry conference where industry and academia come together annually to share technical, scientific and strategic innovations. BioProcess International Magazine is the exclusive provider of pre-conference podcast interviews with speakers who offer their expert perspective and commentary on the scientific trends impacting Drug Product Manufacturing & Fill-Finish Processing; Cell Culture & Upstream Processing; Recovery & Purification; Manufacturing Strategy; and Analytical, Formulation and Quality.

Prior to the conference, this exclusive podcast series gives you access to three interviews with top industry leaders.

First, Barry Buckland, Senior Advisor, Protein Sciences, discusses development of a scaleable and productive insect cell culture-based process for making Flublok, the First FDA licensed recombinant influenza vaccine. Buckland will be presenting at 11:30 am on Wednesday, October 18th at BPI.
In addition, Michael Butler, Professor, University of Manitoba, talks about modeling of glycosylation – predicting profiles of glycosylation from metabolic data. Butler will be presenting at 1:30 pm on Tuesday, October 27th at BPI.

And, Trent Munro, Principal Scientist, Amgen, discusses high-throughput multi-parametric clone screening approach for the generation of tailored production cell lines. Munro will be presenting at 8:05 am on Tuesday, October 17th at BPI.

Listen to all three interviews here: http://bit.ly/1NfG0CN

These podcasts allow you to get a glimpse of what you will experience and learn while attending along with kick-starting the questions you may have for these speakers at the 2015 BioProcess International Conference & Exhibition in Boston.

Thank you for experiencing the BPI Conference Pre-Event Podcasts and we hope to see you in Boston, October 26-29! For more information about the conference, click here: http://bit.ly/1NCAMSw


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Tuesday, August 25, 2015

Bioprocess Characterization: An Interview with Graham McGreath, FUJIFILM Diosynth Biotechnologies


Dr Graham McCreath is Head of Process Design at FUJIFILM Diosynth Biotechnologies. In this post, Graham describes the company's approach to process characterization in advance of his presentation at BPI Boston in October 2015.

What is process characterization and how does it fit with the development and scale-up activities associated with new production processes? 

Process Characterization studies are a series of risk assessments and experiments undertaken as part of process validation and are carried out during late stage process development. These studies generate process knowledge and understanding and are used to develop robust control strategies for process qualification and commercial manufacture. The experiments are often carried out at laboratory-scale using qualified scale down models and statistical designs such as DoE. They are typically carried out once the final scale-up is complete when full scale data is useful in qualifying the required scale-down models.

What is special about the way FUJIFILM Diosynth Biotechnologies perform process characterization relative to other organizations? 

FUJIFILM Diosynth Biotechnologies have been carrying out process characterization for over 15 years and have completed more than 24 characterization projects. In that time we have built up considerable experience and expertise that benefits our clients with respect to how process information is generated, evaluated and how this is translated into a control strategy and registration package.  Our scientists and statisticians work collaboratively with clients to formulate and plan out the most appropriate robust approach for their needs balancing resources and timeline against residual risk. We have also developed some in-house QbD software packages as well to support modern process development; for example, our RAPTA (Risk Assessment Process Template Application) packages are FMEA based risk assessment tools that we use with clients as a predecessor to process characterization. The RAPTA tools enables us to identify, prioritize and document parameters that may be important in either a manufacturing process or an analytical method.

What skills or competencies should a manufacturer have in order to effectively characterize a process? 

Having an understanding of current regulatory expectations, engineering principles and how they apply to scale down, good documentation practices are all important competencies. It is also is very useful to have people in the organisation trained in experimental design. Modern DoE packages are becoming more user friendly but a good understanding of the pros and cons of design options and especially the interpretation of statistical data is very important.

As you developed your approach to process characterization were there any traps that engineers should avoid when developing their own approach? 

Generally, our advice would be to have a logical, well thought out plan, good documentation and rationales and not to overlook having a good scale-down model. The analytical methods to be used, where they are going to be applied and their development status should also be considered carefully. There is little point in executing a large experimental program if you don't have faith in your measurements.

Graham’s presentation is scheduled to take place on Thursday, October 29 at 2:30pm as part of the Cell Culture track.




Join me at #BPIconf
Contact me at nick.hutchinson@parker.com
Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focused on laboratory tools for rapid bioprocess development and characterization. He then worked at Lonza Biologics in an R&D function investigating novel methods for large-scale antibody purification before moving to an operational role scaling-up and transferring manufacturing processes between Lonza sites in the UK, Spain and USA. Nick now works in Market Development at Parker domnick hunter where his focus is in bringing Parker's strengths in Motion & Control to Bioprocessing. This will enable customers to improve the quality and deliverability of existing and future biopharmaceuticals.





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Wednesday, August 19, 2015

Unique Challenges of Cell Therapy Bioprocessing


Joining us in this Cell Therapy Bioprocessing & Commercialization Podcast is Lee Buckler, Cell Therapy Group. Lee discusses the state of the industry and unique challenges that this event is helping tackle. Below is a brief excerpt from the podcast, follow the links below to access the complete podcast and transcript.


What are some of the unique challenges of cell therapy bioprocessing that this event is helping the industry to tackle?

Well, I think that one is just the cross flow of expertise that I mentioned before. So, one of the reasons why I think this Event has been so successful is because it is so closely associated with the bioprocessing journal, as well, in which we’ve really been trying to raise the level of publications related to cell therapy bioprocessing to try and encourage that cross flow of expertise and exchange of information between those in traditional biologics bioprocessing and those who are still cutting their teeth in cell therapy bioprocessing. So, the lack of that cross flow has been one of the challenges that we face. Bringing people in who have experience with larger-scale systems. Cell therapy is still being produced in relatively small scales. Even when we think it’s big scale, it’s still relatively small scale. So, bringing people with large-scale experience and thinking ahead about how these cell products are going to be manufactured on a large scale if we get great clinical efficacy is a tremendous asset.

Other than that the unique challenges differ significantly depending on whether you’re talking about autologous vs. allogeneic. One of the challenges with autologous is that it doesn’t really scale-up very well because a batch is a lot. So, there is a lot of cost of goods embedded in the human processing and in the testing. So, innovation with autologous cell therapies is around closing systems up. Potentially they don’t have to be inside playroom environments and/or in bringing lower cost batch testing solutions to cell therapy products.

When you’re looking at allogeneic, of course, depending on whether you’re looking at an adherent or non-adherent cell population, you’re really looking at how can you take the cell expansion process from key flasks or roller bottles or vats into tanks where we can do scale-up at a much larger scale and hopefully, potentially, reduce the media consumption because media consumption is the largest – as has been pointed out in past sessions of this conference – media consumption is the largest cost driver.

Some of the really important data that has been presented here and then also published in Bioprocessing International is some of these metrics around what is the exact cost of the processing technology that we are using today vs. what we are going to have to get to in the future.


Be sure to join us at Cell Therapy Bioprocessing & Commercialization in Alexandria, VA - September 30th to October 2nd, 2015. Register before 9/4 and save $300 with the code XB15188BLOG.



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Monday, August 17, 2015

Overcoming the challenges of high concentration protein formulations


There is a trend within the biopharmaceutical industry for companies to develop formulations for protein drugs with extremely high concentrations. Such formulations provide advantages to both patients and clinicians as they allow biological drugs to be delivered via the sub-cutaneous route of administration rather than by the more traditional intravenous route. Sub-cutaneous delivery allows patients to receive treatment in a clinic or even administer the drug themselves while intravenous infusions tend to require the patient to make a hospital visit which increases the cost of treatment. However, if a patient is able to self-administer the pharmaceutical drug they require to treat a chronic disease then they are more able to lead a normal life which is a tremendous benefit (Highly concentrated protein formulations: Finding solutions for the next generation of parenteral biologics, J Kling, 2014).
The challenge of processing highly concentrated protein drugs
Being able to provide a biopharmaceutical at a formulated concentration of 100 g/L or higher can be a means by which biopharmaceutical companies can gain an advantage over one another in an increasingly competitive marketplace. However, developing such formulations is no trivial task because at high concentrations, protein solutions can become very viscous and difficult to process and the proteins themselves can aggregate. The viscosity of these solutions can challenge filtration equipment and can lead to significant yield losses in the final stages of the processes when the product has its greatest value. Protein aggregation can lead to a reduction in the pharmaceutical’s potency and can even trigger an immune reaction to the drug.

Innovation at the interface with formulations

The topic of high concentration protein formulations will be covered at the BioProcess International Conference & Exposition 2015 to be held on October 26-29 in Boston, MA. Sigma S Mostafa, PhD, Director, Process Development at KBI Biopharma Inc will be chairing a session on ‘Innovation at the Interface with Formulations’. Pfizer are scheduled to present on ‘Challenges of High Concentration Formulations – Dealing with Viscosity and Excipients’ while Mark Moody will present on ‘Opportunities and Challenges of High Concentration Biologics: Case Studies’. The session promises to address some of the key issues manufacturers face when processing concentrated protein solutions.

Have your say

Protein biopharmaceuticals are being formulated to 100 g/L even 200 g/L, however, some have proposed that concentrating to 500 g/L may be desirable. In your opinion, what is the maximum concentration that is required or attainable for protein drug formulations?

Join me at #BPIconf
Contact me at nick.hutchinson@parker.com
Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focused on laboratory tools for rapid bioprocess development and characterization. He then worked at Lonza Biologics in an R&D function investigating novel methods for large-scale antibody purification before moving to an operational role scaling-up and transferring manufacturing processes between Lonza sites in the UK, Spain and USA. Nick now works in Market Development at Parker domnick hunter where his focus is in bringing Parker's strengths in Motion & Control to Bioprocessing. This will enable customers to improve the quality and deliverability of existing and future biopharmaceuticals.





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Tuesday, August 11, 2015

Antibody Repertoires - Past, Present and Future

IBC's Antibody Engineering & Therapeutics event taking place December 7-10 in San Diego is the #1 forum for academia and industry to connect for scientific exchange and networking in Antibody Engineerings & Therapeutics, Immunobiology and Next-Generation Binders. To give you a sneak peek at the high caliber of the content presented at the conference - we would like to give you FREE access to complete videos from some of the 2014 presentations.

 http://www.ibclifesciences.com/AntibodyEng/presentations.xml?utm_source=NMM&utm_medium=BL&utm_campaign=081115_BL_fullsessionaccessform#form

We hope to see you in San Diego this December!


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Monday, August 10, 2015

Designing and building next gen biomanufacturing facilities in Asia


Singapore has become a significant hub for biopharmaceutical companies looking to manufacture in Asia. Locating manufacturing facilities in Asia allows companies to product biologics close to important and expanding markets and improve their cost structure. Amgen is one such company that is increasing its presence in Asia with a $160 million investment to build a manufacturing facility in Singapore for the production of denosumab the active ingredient in Prolia and XGEVA. Regulatory filing is expected to take place in 2016.

Amgen’s next generation biomanufacturing facility
Kimball Hall, Vice President of Manufacturing and site head at Amgen Singapore Manufacturing Pte. Ltd. will be presenting at Bioprocess International’s 2015 Conference and Exhibition in Octoberon “Amgen’s next generation biomanufacturing facility”.

The facilities smaller, modular design will allow it to be readily replicated for future facilities in order to increase capacity while expanding the company’s global network and reach. It will heavily utilize single-use technologies including bioreactors up to 2000L in scale. Also of interest is Amgen’s choice to make use of continuous processing steps which is a topic I’ve covered in this blog previously.

Next gen facility saves time and money
The approach that Amgen has adopted is set to save the company money. In a recent interview Kimball was quoted as saying Amgen’s “next-generation biomanufacturing require ¼ of the capital costs, 1/3 of the operating expense; and half of the construction time” (Inside Look at Amgen’s Next-Gen Biomanufacturing by Denice Cabel).

The environmental impact of single-use technologies
Interestingly, Amgen considers the use of disposable technology as being more environmentally friendly than traditional stainless steel plants. This for many is counterintuitive as they see the single-use technologies made from plastics as part of a throwaway culture but they neglect to consider the considerable energy and water requirements needed to produce the clean steam, WFI and cleaning solutions that are required to prevent contaminations in reusable bioprocessing equipment.

Global supply chain networks are becoming increasingly important as was highlighted in last week’s post on final fill finish operations. Interestingly the trend to develop these networks is driving innovation and the adoption of novel technologies.
Have your say
Singapore has a significant cluster of biomanufacturing facilities and is important on the global stage. Where do you see the next big hub developing?

Join me at #BPIconf

Contact me at nick.hutchinson@parker.com

Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focused on laboratory tools for rapid bioprocess development and characterization. He then worked at Lonza Biologics in an R&D function investigating novel methods for large-scale antibody purification before moving to an operational role scaling-up and transferring manufacturing processes between Lonza sites in the UK, Spain and USA. Nick now works in Market Development at Parker domnick hunter where his focus is in bringing Parker's strengths in Motion & Control to Bioprocessing. This will enable customers to improve the quality and deliverability of existing and future biopharmaceuticals.


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Friday, August 7, 2015

This Week in BioPharma: 8/3-8/7

Here is the top news from the biopharmaceutical industry this week:

Biotechnology is helping to heal Delaware: Nearly 22,000 women will be diagnosed with ovarian cancer this year. Another 14,000 will die from the disease. One Delaware biotech firm is working to change that. In December, Wilmington-based AstraZeneca Pharmaceuticals released Lynparza, a new medicine for women with advanced ovarian cancer. Innovative treatments like Lynparza help Delaware patients live longer and healthier lives. Drug development also keeps Delaware's economy healthy by creating jobs and supporting local businesses. But now, Congress may jeopardize the health of our state and its residents with ill-advised changes to Medicare Part D and patent laws. Read the full post here.

U.S. officials warn medical devices are vulnerable to hacking: The federal government is warning about a medical device that could be tampered with by hackers. The FDA and Department of Homeland Security issued a statement that "strongly encourages" health care facilities to discontinue the use of Hospira's Symbiq infusion pump after officials learned the devices are vulnerable to cybersecurity threats. The medical device company confirmed that the computerized pumps -- which continuously deliver medication over an extended period -- could be accessed remotely through a hospital's network. This could allow an unauthorized user to control the device and change the dosage of medication the pump delivers to a patient. Read the full post here.

Allow medical devices sector to work with doctors: Pitching for allowing medical devices industry to engage doctors, industry body CII today said preventing medical practitioners to undergo training about latest technologies may be detrimental. Currently, under the voluntary the Universal Code for Pharmaceutical marketing Practices (UCPMP) industry is not allowed to engage medical practitioners for continued medical education on latest technologies, CII said in a statement. "Medical Device Industry is an innovation driven industry and needs to work with medical practitioners as well as paramedical professional in close proximity," the industry chamber said.  Read the full post here.

How can we derisk innovation in pediatric medical devices?: Sometimes, kids need intensive medical treatment – and the tools used for adults aren’t necessarily suitable to treat smaller, growing bodies. This presents a unique challenge for surgeons and clinicians, who find themselves with limited options when treating sick children. That’s where the Sheikh Zayed Institute for Pediatric Surgical Innovation comes in. It’s a division of the Washington, D.C.-based Children’s National Health System – and focuses on making pediatric surgery more precise, less invasive and, ideally, pain-free. Kolaleh Eskandanian, executive director of the Institute, spoke with MedCity News about the unique challenges in pediatric medical device innovation – and ways they’re helping jumpstart entrepreneurship in this small but important market. Read the full post here.


Technavio Says the High Demand for Biopharmaceuticals Will Inflate the Global Single-use Bioprocessing Systems Market Through 2019:  Technavio has published a new report on the global single-use bioprocessing systems market, which is expected to grow at a CAGR of more than 34% from 2015-2019. The new report indicates the increase in the aging population is leading to a rapid increase in patient population suffering from diseases such as diabetes, hypertension, musculoskeletal and cardiovascular diseases, chronic kidney diseases, cerebral strokes, and cancer. This increases the demand for biopharmaceuticals among patients. Read the full post here.


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Thursday, August 6, 2015

Antibody Engineering & Therapeutics Interview | Ira Pastan, M.D., National Cancer Institute

The annual Antibody Engineering & Therapeutics is the #1 forum for academia and industry to connect for scientific exchange and networking in antibody engineering & therapeutics, immunobiology and next-generation binders. The 2015 event is taking place December 7-10 in San Diego, CA.

Below is an interview conducted at the 2014 event with Ira Pastan, M.D., Co-Chief Laboratory of Molecular Biology, National Cancer Institute. At the event, Dr. Pastan presented "Recombinant Immunotoxins: From Conception to Clinical Reality in Leukemia and Mesothelioma"





Want to hear more from experts like Dr. Pastan? Then join us at the 2015 Antibody Engineering & Therapeutics event. Register today at save $550 when you use the code D15172BLOG.

See you in San Diego!


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Wednesday, August 5, 2015

What are the supply chain challenges associated with the commercialization of cell therapy products?



Joining us in this Cell Therapy Bioprocessing & Commercialization Podcast is Jessica Carmen, Business Development Manager of Lonza Walkersville. Jessica discusses supply chain & logistical challenges associated with commercialization, the evolution of the cell therapy field and where it is headed in the next five years, advancements in technology and much more. Below is a brief excerpt from the podcast, follow the links below to access the complete podcast and transcript.


Are there unique supply chain challenges associated with the commercialization of cell therapy products?

Yes, there are. There are many raw materials that are used in the manufacture of cell-based products that can pose a challenge when considering commercial needs, an example of which is the animal serum. Most cell types are culture-expanded in animal serums and there is a move in the field towards serum-free conditions. This is good from a supply chain and safety risk standpoint. However, most companies still employ animal serum in their processing and will need to consider the increasing costs and logistical challenges associated with the ever-increasing demand for this raw material. 


Be sure to join us at Cell Therapy Bioprocessing & Commercialization in Alexandria, VA - September 30th to October 2nd, 2015. Register before 9/4 and save $300 with the code XB15188BLOG.



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Monday, August 3, 2015

Increasing the flexibility of fill finish operations with single-use technology

There are many benefits to using single-use technology for the manufacture of biopharmaceuticals. The enabling aspect of the technology that allows closed-system processing has been examined in a previous postThe single-use principle can be applied across the biomanufacturing process with bioreactors, chromatography and cross flow filtration all available in single-use formats.

Single-Use and Fill Finish

The role of single-use in adding flexibility to fill finish operations will be the subject of a presentation given by Chris Smalley, Ph.D., from Merck & Co. at the Bioprocess International 2015 Conference that will be held in Boston in October. Chris’presentation will be part of the ‘Drug Product Manufacturing & Fill-Finish Processing’ track which is new for this year.

In a recent interview, Chris highlighted the fact that single-use technologies can play an important role in helping to rapidly establish global networks of fill finish operations. These are required in order to meet emerging demands (Merck Champions Single-Use ByAddressing Emotion Vs. Science, by Trisha Gladd at Bioprocess Online)

One way of developing such a network will be to utilize existing manufacturing locations and staff. Minimizing the amount of work required to redevelop these existing facilities around the world will be crucial in achieving the level of operational agility that will likely be required. Taking a single-use approach to fill finish will allow this by reducing the need for HVAC, cleanrooms and WFI systems. The affordability of drugs can be improved as the capital costs, labor requirements and time needed to design and build new facilities will be reduced.

Particulates and Extractables

In the article, Smalley addresses two common concerns about single-use technologies that are particularly pertinent during fill finish operations, namely, particulates and extractables. These are especially important issues for fill finish because there are no further processing steps that can remove impurities derived from equipment or consumables at this stage in the process. Smalley believes that the available studies show that there is little or no risk to patients from particulates and he is an advocate of suppliers providing adopting the BPOG guidelines with respect to extractables.

To facilitate the implementation of single-use across the company, Merck have a Single-Use Network (SUN) of advocates that set guidelines and define good practices. Smalley sees standardization as a key success factor for single-use implementation within the industry. He will no doubt be interested in participating in the Town Hall Forum Discussion on single-use technologies with industry organizations such as BPSA, BPOG, PDA, ASME BPE and ASTM.

Have your say

To what extent do you think challenges, such as particulates and extractables, relating to the implementation of single-use technologies can be overcome?


Join me at #BPIconf
Contact me at nick.hutchinson@parker.com


Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focused on laboratory tools for rapid bioprocess development and characterization. He then worked at Lonza Biologics in an R&D function investigating novel methods for large-scale antibody purification before moving to an operational role scaling-up and transferring manufacturing processes between Lonza sites in the UK, Spain and USA. Nick now works in Market Development at Parker domnick hunter where his focus is in bringing Parker's strengths in Motion & Control to Bioprocessing. This will enable customers to improve the quality and deliverability of existing and future biopharmaceuticals.


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Friday, July 31, 2015

Are You passionate about the Future of Biobanking? Join our event as a Guest Blogger!

Earn a complimentary all-access pass to the 8th Annual Biorepositories and Sample Management Summit by serving as a Guest Blogger at the event.



IIR's 8th Annual Biorepositories and Sample Management Summit
October 12- 14, 2015
Hilton Back Bay
Boston, MA

We are looking for an industry expert with interest in the following topics:

• New technology and innovative sample management;
• Sample Quality Assurance/Control Methods;
• Sustainable business models for Sample management
• Biospecimens;
Biobanking to Support Drug Development;
• Bioprocessing and Biopreservation Techniques;
• Precision medicine;

...and who would like to learn about the future trends in biobanking!

The premise is to provide Biorepositories and Sample Management - related articles, whitepapers, and overall original content.

What You get is:
• FREE pass to the conference (valued up to $2,195);
• Access to extensive social learning activities;
• Exclusive admission to a networking community in the industry of your interest!

You also have a chance to GAIN exposure through our five health related-blogs with over 2000 unique visitors monthly each and more than 20 healthcare LinkedIn groups. 

Learn more about the IIR's 8th Annual Biorepositories and Sample Management Summit by visiting the website.

Interested & want to learn more about this opportunity? Please contact Alexandra Pump at apump@iirusa.com

We hope to have you join us in Boston!

Stay tuned for our weekly news round up! 

Subscribe to our blog or follow us on Twitter: @futurebiopharma



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Wednesday, July 29, 2015

New Development in Monoclonal Antibodies!

A recent development in monoclonal antibodies for Alzheimer's was announced in an article by FierceBiotech Research. Scientists at NYU Langone Medical Center's Center for Cognitive Neurology is conducting a study that suggests monoclonal antibodies designed to specifically target misfolding proteins in soluble, aggregated states, could be ideally used to treat neurodegenerative diseases such as Alzheimer's, ALS, Parkinson's, and Huntington's.

Monoclonal antibodies are now used for treatments of a wide array of diseases, especially cancer, autoimmune, and inflammatory diseases and the studies are only expanding. With the market for monoclonal antibodies exploding to an estimated $31.7 billion by 2017, don’t miss out on the opportunity to discover the future of antibody engineering at the upcoming IBC’s Antibody Engineering & Therapeutics event.

This is the most trusted antibody engineering event in the industry where you will not only connect with over 700 antibody industry experts, but also learn about the latest antibody science and applications to expand your pipeline of antibody therapeutics.

Hear from the below experts this December 7-10  in San Diego, CA to uncover more about monoclonal antibodies and recent developments for non-cancer and orphan indications.

  • Trudi Veldman, Ph.D.., Senior Director Biologics Generation, AbbVie Bioresearch Center
  • Patrik Maurer, Ph.D., Head Research and Preclinical Development, ESBATech, a Novartis Company, Switzerland
  • Jos Raats, Ph.D., CEO, ModiQuest B.V., The Netherlands
  • Mary Keir, Ph.D., Scientist, Immunology, Tissue Growth and Repair (ITGR), Diagnostic Discovery, Genentech, Inc.
  • Ahuva Nissim, Ph.D., Reader in Antibody and Therapeutic Engineering, Biochemical Pharmacology, Queen Mary University, United Kingdom
  • Ulrich Wuellner, Ph.D., Associate Director, Discovery Research, Covagen AG, Switzerland
  • Chung-Ming Hsieh, D.SC., Associate Director, Biologics, AbbVie Bioresearch Center
  • James Larrick, M.D., Ph.D., Managing Director and Chief Medical Officer, Panorama Research Institute and Velocity Pharmaceutical Development
  • Bo Yu, Ph.D., Co-founder and CSO, Larix Bioscience, LLC
  • Wendy Williams Ph.D., Scientist II, Antibody Discovery and Protein Engineering, MedImmune, United Kingdom
  • Vaughn Smider, M.D., Ph.D., Assistant Professor, Department of Cell and Molecular Biology, The Scripps Research Institute
  • Mark De Boer, Ph.D., CEO, Fast Forward Pharmaceuticals BV, The Netherlands
  • Peter Ulrichts, Ph.D., Principal Scientist, arGEN-X BVBA, Belgium

Download the Brochure for the Full Session and Speaker Details.

Accelerate your antibody research, discovery efforts and clinical programs at the most comprehensive event for comparing and contrasting engineering, discovery and development strategies for different antibody modalities.

Plus, take advantage of an extra $100 off the current rate with code D15172BLOG - Register Now!



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Tuesday, July 28, 2015

Accelerate Your Cell, Gene and Cancer Immunotherapies to Market - Best Rate Ends Friday



Save $400 with the code XB15188BLOG by Friday, July 31 | Register here.

IBC's Cell Therapy Bioprocessing & Commercialization is the most focused conference for cost-effective and efficient cell, gene and immunotherapy approaches that accelerate cell-based product development and production towards commercial success >> Download the full agenda.

Key Topics Include: 
• Applying Genome Editing and Other Disruptive Technologies
• Developing Scalable and Transferrable Manufacturing Processes
• Biopreservation, Cold Chain Management and Patient Delivery
• Developing Successful Business Models
• Fostering Partnerships and Outsourcing Strategies for R&D and Manufacturing
• Pricing, Reimbursement, and Adoption
• Negotiating the Regulatory Pathways to Approval

_______________________________________________________________

Save $400 with the code IMMUNO15BL by Friday, July 31 | Register here.

IBC's Immuno-Oncology is the industry's leading resource for diving into the current issues surrounding efficacy and response rates with first generation immunotherapies to propel the next wave of cancer immunotherapies >> Download the full agenda.

Key Topics Include: 
• Strategies for Combination Therapeutics
• Advances with Checkpoint Inhibitors
• Agnostic Antibody Agents
• Advances in Cancer Vaccines
• Advancing the Next Wave of Cancer Immunotherapies


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Monday, July 27, 2015

How to successfully integrate continuous capture with perfusion bioreactors


In a previous post I described the drivers for, and, benefits from, the trend towards the continuousproduction of biopharmaceutical drugs in which I referenced the article of Veena Warikoo from Genzyme, a Sanofi company, and co-workers published in 2012 on the “Integrated Continuous Production of RecombinantTherapeutic Proteins” (Biotech Bioeng, 2012;109: 3018-3029). Amongst Veena’s contributing authors is Konstantin Konstantinov a key contributor to the literature on continuous bioprocessing and Keynote speaker at the Bioprocess International 2015 Conference with a presentation entitled “What is the Future of Continuous Processing  – What is the Time Frame for Implementing Fully Continuous Processing in Commercial Production?"
Extending continuous processing downstream to include the capture step

A key concept that the team from Genzyme developed is the integration of continuous chromatography with a perfusion bioreactor for the production of both high volume and stable monoclonal antibodies and low volume, less stable recombinant human enzymes. A 12 L bioreactor was operated for up to 70 days by utilizing the Alternating Tangential Flow (ATF) cell retention technology. The ATF permeate that was harvest was loaded directly onto a periodic counter current (PCC) chromatography system. Systems such as these are now available from a variety of suppliers including GE Healthcare, Pall, Semba and NovaSep. Genzyme were able to operate the PCC system in a fully closed and sterile state for a prolonged period of time.


The benefits of integrating continuous culture with continuous capture
Adopting this approach can lead to significant benefits because of the high cell densities and volumetric productivities that can be achieved. This allows significantly smaller bioreactors to be used thereby reducing facility size and capital costs. The ATF system eliminated the need for a more complex harvesting system, however, integration with PCC eliminated the need for large hold tanks, a non-value adding operation, and allowed the capture column to be reduced by a minimum of two-fold.

Improved product quality of less stable proteins

Integration of upstream and downstream operations in this way allows for the continuous flow of product from the bioreactor, through the capture step and into the chromatography eluate and mitigates the risk of product degradation of less stable proteins.

Though the issue of stability may be less of a concern for monoclonal antibodies, the team have created a platform capable of delivering a range of biopharmaceuticals from within a single facility.

What is the Time Frame for Implementing Fully Continuous Processing in Commercial Production?

How would you answer this question? Do you think the industry will see this within 5 years? 10 years? 20 years? Or more?

Dr Nick Hutchinson

Join me at #BPIconf

Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focused on laboratory tools for rapid bioprocess development and characterization. He then worked at Lonza Biologics in an R&D function investigating novel methods for large-scale antibody purification before moving to an operational role scaling-up and transferring manufacturing processes between Lonza sites in the UK, Spain and USA. Nick now works in Market Development at Parker domnick hunter where his focus is in bringing Parker's strengths in Motion & Control to Bioprocessing. This will enable customers to improve the quality and deliverability of existing and future biopharmaceuticals.


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What did last year's Antibody Engineering & Therapeutics attendees have to say about their experience?

See what attendees of last year's Antibody Engineering & Therapeutics had to say...

"Comprehensive coverage. In-depth analyses of the past, present and outlook of the antibody therapyfield/industry" - Li-Hsien Wang, Regeneron


"I am new in the antibody therapeutic field and this conference provides significant amounts of valuable information to me." - Ulrik Lademann, Senior Scientist, Symphogen

"This is best meeting dedicated to Antibodies! Small enough to be able to be able to interact with people and big enough to cover all the important topics" - Monica Schaller, University Hospital Bern Inselspit

"Great conference, inspiring atmosphere, very motivating speakers and encouraging networking sessions!! Would love to come back!" - Priyal Thakur, BD Biosciences

"Great conference! Informative and addresses state-of-the-art advances in antibody/drug technologies." - James Tamura, Macrogenics

"Beautiful overview on antibody modeling strategies of different players on the market!" - Tobias Raum, Amgen Research Munich

"The most updated conference on Antibody Engineering & Therapeutics" - Jean-Luc Teillaud, INSERM, France

"The workshop program continues to be a venue for in-depth exploration of specialty topics on antibodies" - Ray Sweet, Senior Director and Fellow, Biologics Research, Janssen R&D

"Informative and Timely!" - Colin Brenan, CTO, R&D, HiFiBio BV

"World class group of leading antibody researchers" - Caroll Osgood, Alleghany Brain and Spine


Don't miss out on the #1 forum for academia and industry to connect for scientific exchange and networking in antibody engineering & therapeutics, immunobiology and next-generation binders.

Check out the complete program here.

Register today with the code D15172BLOG and save $550!


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Thursday, July 23, 2015

Antibody Engineering & Therapeutics Interview | Paul Sondel, M.D. Ph.D., University of Wisconsin

The annual Antibody Engineering & Therapeutics is the #1 forum for academia and industry to connect for scientific exchange and networking in antibody engineering & therapeutics, immunobiology and next-generation binders. The 2015 event is taking place December 7-10 in San Diego, CA.

Below is an interview conducted at the 2014 event with Paul Sondel, M.D. Ph.D., Reed and Carolee Walker Professor of Pediatrics, Human Oncology, and Genetics, University of Wisconsin. At the event, Dr. Sondel presented "Translating Preclinical Immunocytokine Development into Clinical Testing"

Check out his interview below...



Want to hear more from experts like Dr. Sondel? Then join us at the 2015 Antibody Engineering & Therapeutics event. Register today at save $550 when you use the code D15172BLOG.

See you in San Diego!



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Wednesday, July 22, 2015

Today's Challenges in Cell Therapy


 

Joining us in this Cell Therapy Bioprocessing & Commercialization Podcast is Marty Giedlin, VP of Development at Sangamo BioSciences, Inc. Marty discusses key industry challenges, the evolution of the cell therapy field and where it is headed in the next five years, advancements in technology and much more. Below is a brief excerpt from the podcast, follow the links below to access the complete podcast and transcript.


What are the challenges that you’re experiencing in your industry?

Well, I guess it really depends on what kind of cell therapy you’re talking about. We at Sangamo are processing both autologous T-cells and autologous stem cells. We have the most experience in our T-cell program where we knock out the CCR-5 receptor for HIV in HIV-positive patients. So, the challenges are trying to find that patient population that’s most amenable to this type of therapy, both in viral load, how many years they’ve been in retroviral therapy and that sort of thing. And also finding out which of the CD4 cells – which sub-population – is most important in controlling HIV. So, those are some of the challenges that are facing us there.

With our stem cell program, we have a partnership with CIRM (California Institute for Regenerative Medicine) in California with the City of Hope where we are looking at using CD34 stem cells either from peripheral blood or from bone marrow. What sub-population of those cells are really those that have the capacity for self-renewal over time? Those are the cells that we really want to target to do our gene modification technology.

Then, there are culture conditions to minimize replication, retain stemness and maximizing engraftment with respect to CD34s. And then we’re looking at ways of mobilizing peripheral blood CD34s and how does that affect stemness with respect to CD34s? And then also looking at different ways of bone marrow harvest. So, are there better ways of getting maximal yield to make sure we get enough cells to give back to the patient?

So, for us in the adoptive cell therapy, those are some of the challenges that we’re looking at over the next three to five years.



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