Friday, February 27, 2015

Has disposable technology been tested on a large scale yet?

Biopharmaceutical Development and Production Week speaker Siddhartha Shrivastava, Ph.D., Senior Scientist, Downstream Process Development, Patheon recently took some time to sit down with us and discuss his upcoming presentation centered around downstream processing.  Today, he shares  the importance of disposable membrane chromatography systems for mAb purification.


Has disposable technology been tested on a large scale yet at Patheon? 

As I said, there are two parts. One is the clarification and we are testing Clarasolve Filters and  he second part is we are replacing chromatographic columns with membranes. So, for our process --- in essence, we are not reinventing the wheel because Clarasolve Filters are from Millipore and the membranes that we are using are from Natrix, one of our collaborators. 
So, we have not reinvented the wheel. What we have done is we have merged both these technologies to come up with a hybrid process which is far more effective and far cheaper compared to the classical platform or traditional platform methods. 
Having said that, we have not yet tested the full process at scale. But, Clarasolve has been using multiple commercial products and they are being used multiple times successfully both by Patheon and by many other companies, as well. And Natrik members are also employed in many of the clinical trials. So, individual contributors are already being tested and are proven in the market that they are liable to be used for the production of human injectibles. We have mix them to produce the whole process and, of course, --- as you know, Patheon is a CDMO and we have got ample opportunities to test them and we are in the process of testing them. But, of course, they are not yet tested at scale.

In this interview Dr. Shrivastava also discusses disposable technology, why it's more appealing than traditional technology and it's cost effectiveness, .  Download the entire interview here.


Dr. Shrivastava will be presenting Disposable Membrane Chromatography Systems as a Platform for mAb Purification on Thursday, April 2 at Biopharmaceutical Development and Production Week.  As a reader of this blog,when you register to join us March 30-April 2, 2015, you can save 20% off standard rates when you mention code XB15155BLOGJP! Have any questions? Reach out to me at jpereira@iirusa.com.


Share this article with your social network, just click below to share now!


Wednesday, February 25, 2015

[Video] ALN-TTR Programs for Transthyretin Amyloidosis

In today's featured presentation from TIDES 2014, Jared A. Gollob, M.D., Vice President of Clinical Research at Alnylam Pharmaceuticals, Inc. presents how explains how Transthyretin Amyloidosis is formed and how it develops throughout the body.  Transthyretin (TTR) amyloidosis is caused by the deposition of liver-derived mutant and/or wild-type TTR in peripheral nerves, GI tract and the heart. Patisiran (ALN-TTR02), which is being developed for familial amyloidotic polyneuropathy (FAP), is a systemically administered lipid nanoparticle (LNP) formulation of a small interfering RNA (siRNA) targeting wild-type and all mutant forms of TTR that is currently in Phase 3. ALN-TTRsc, which is being developed to treat familial amyloidotic cardiomyopathy (FAC), is a subcutaneously administered N-acetylgalactosamine (GalNAc)-conjugated siRNA also targeting all forms of TTR that is currently in Phase 2. This presentation will review the clinical results to date with both patisiran and ALN-TTRsc. To learn more, watch the actual presentation:


TIDES 2015 will take place May 3-6, 2015 in San Diego, California.  This year, Ravi S. Harapanhalli, Ph.D., Vice President, Technical, PAREXEL International and Former Branch Chief, Office of New Drug Quality Assessment, US FDA, will be on hand to present Strategies and Challenges in the Development of Oligonucleotide and Peptide Drugs: Perspectives on DrugDevice Combinations and Drug Product.  For more information about this session and the rest of the program, download the agenda.  As a reader of this blog, when you register to join us and mention code XB15180BLOG, you can save 20% off standard rates.


Share this article with your social network, just click below to share now!


Friday, February 20, 2015

How much more cost effective is a disposal technology approach?

Biopharmaceutical Development and Production Week speaker Siddhartha Shrivastava, Ph.D., Senior Scientist, Downstream Process Development, Patheon recently took some time to sit down with us and discuss his upcoming presentation centered around downstream processing.  Today, he sheds light on the cost effectiveness of disposable technology.


How much more cost effective is this approach?
Sid: To answer this question I would like to explain the mAb or the industrial standard of gold standard of antibody purification. So, of course, as I said that requires a full battery of chromatographic columns that would be paired with the expensive resins. Among those expensive resins, the major resins which are used for antibody purification is Protein A, which is super expensive. So, that can be a significant. A 100 liter column would run upwards of around $1.6 to $2.5 million dollars. So, it is super expensive and the whole process costs millions of dollars. But, in the approach that we are going to present, you will see that we have replaced these expensive chromatographic columns with our collaborator company Natrix’s, hydrogel membranes, which has reduced the cost significantly. 
And we have also change the classical centrifugation approach to purify the harvest material or the depth filtration material with high capacity new material from Millipore called: “Clarasolve filters”. With the combination of these two systems, we have seen and we have estimated that there would be a significant savings in cost that would run upwards of millions of dollars in whole process. There is a significant chances that this process is very lucrative and very appealing and is also working very nicely.

In this interview Dr. Shrivastava also discusses the appeal of disposable technology and how it applies to the large scale.  Download the entire interview here.

Dr. Shrivastava will be presenting Disposable Membrane Chromatography Systems as a Platform for mAb Purification on Thursday, April 2 at Biopharmaceutical Development and Production Week.  As a reader of this blog,when you register to join us March 30-April 2, 2015, you can save 20% off standard rates when you mention code XB15155BLOGJP! Have any questions? Reach out to me at jpereira@iirusa.com.


Share this article with your social network, just click below to share now!


Wednesday, February 18, 2015

[Video] TIDES: AZD9150 and its Effect on Tumors

In today's featured interview from TIDES 2014, David C. Blakey, Ph.D., the Chief Scientist of Oncology iMED at AstraZeneca discusses the next generation of antisense molecules, AZD9150 and its effect on tumors and why TIDES is a great place to be for the industry. He also talks about bigger traction, which tackle lower uptake tissues and a combination of both peptides and nucleotides. To learn more, watch this interview:



This year at TIDES 2015, AstraZeneca's Regina Fritsche-Danielson, Ph.D., Associate Professor and Senior Director and Head of Bioscience Heart Failure Department will present Modified mRNA as a Potential Therapeutic for Patients with Cardiovascular Disease.  For more information on this session and the rest of the program, download the agenda.  As a reader of this blog, when you register to join us and mention code XB15180BLOG, you can save 20% off the standard rate.


Share this article with your social network, just click below to share now!


Friday, February 13, 2015

Why is disposable technology more appealing compared to conventional technology?

Biopharmaceutical Development and Production Week speaker Siddhartha Shrivastava, Ph.D., Senior Scientist, Downstream Process Development, Patheon recently took some time to sit down with us and discuss his upcoming presentation centered around downstream processing.  Today, he looks at the appeal of disposable technology.

Why is disposable technology more appealing compared to conventional technology?
Continuing from where I left off in my last sentence, as I said if the product has got a long shelf-life, a long demand, that makes sense for us to invest in it and create a good infrastructure, a good footprint and bear the high operational and capital expenditure. But, if the product is in the development phase and you need to have some quick lots of drugs so that we can try clinically, that does not make sense. And, by moving to the disposable technology we are also reducing the chances of cross contamination.

As I said before, again, cleaning, and associated cleaning validation, basically reduced maintenance costs, reduced lead times, increased speed of implementation and time to market , that can be significantly be reduced because we have reduced significantly the time of the processing over the 30 some processes. And we have also reduced the labor costs because of the low cleaning requirement or cleaning validation requirement. And, of course, low space requirement and footprint requirement. That is a main reason why disposable technology is more appealing and more and more people want to go towards that.

In this interview Dr. Shrivastava also discusses disposable membrane chromatography systems, it's cost effectiveness, and how it applies to the large scale.  Download the entire interview here.


Dr. Shrivastava will be presenting Disposable Membrane Chromatography Systems as a Platform for mAb Purification on Thursday, April 2 at Biopharmaceutical Development and Production Week.  As a reader of this blog,when you register to join us March 30-April 2, 2015, you can save 20% off standard rates when you mention code XB15155BLOGJP! Have any questions? Reach out to me at jpereira@iirusa.com.


Share this article with your social network, just click below to share now!


Wednesday, February 11, 2015

[Video] Breakthrough Status: Are You Ready?

In today's featured presentation from TIDES 2014, Jeffrey Baker, Ph.D., Deputy Director, Office of Biotechnology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration talks about FDA SIA (Safety and Innovation Act). He presents a rundown of this act and talks about NDAs (Non-disclosure agreement), and BLAs (Biologics License Applications). Baker states that FDA SIA has made available a pathway for rapid approval of drugs critical to public health, however companies need to be prepared to manufacture and meet patient needs. Are you ready? For details, watch the presentation:



TIDES 2015 will take place May 3-6, 2015 in San Diego, California.  This year, Ravi S. Harapanhalli, Ph.D., Vice President, Technical, PAREXEL International and Former Branch Chief, Office of New Drug Quality Assessment, US FDA, will be on hand to present Progress in Advancement of RNAi Therapeutics.  For more information about this session and the rest of the program, download the agenda.  As a reader of this blog, when you register to join us and mention code XB15180BLOG, you can save 20% off standard rates.


Share this article with your social network, just click below to share now!


Friday, February 6, 2015

What is the importance of disposable membrane chromatography systems for mAb purification?

Biopharmaceutical Development and Production Week speaker Siddhartha Shrivastava, Ph.D., Senior Scientist, Downstream Process Development, Patheon recently took some time to sit down with us and discuss his upcoming presentation centered around downstream processing.  Today, he shares  the importance of disposable membrane chromatography systems for mAb purification.

What is the importance of this work?
Sid: Well, the topic as name suggest --- the non-chromatographic platform for mAb purification. As we can see, around 70-75% of those therapies in the market are based on antibodies and the classical way in which industry approaches (this is) to purify them is a bed chromatography approach. What that means is that you need to have a good platform of bed chromatography columns with some costly resins. Of course, we need to have a lot more space, a big footprint resulting in high capital expenditure, as well as operational expenditures for those platforms to purify the mAb.
It is good for a product which has got a long shelf-life or is high in demand, but for the products which have got a low demand or are only for therapeutic or clinical use or clinical trials, that kind of expenditure does not make sense. So, we are trying to focus that part, the drugs which have got a low demand and the product that needs fast turnover, we are trying to develop the technology which will be, in essence, a disposable or single-use so that we would have low validation cost, low cleaning cost and low installation cost and of course, what that would mean are low leading times on the material process that would, of course, mean the product cost would be reduced significantly. 
So, this is the essence and the target of the work that we did. Here at Patheon we are trying to generate a uniform platform matter for the mAB purification using this technique. This will be described in my presentation, as well.
In this interview Dr. Shrivastava also discusses disposable technology, it's cost effectiveness, and how it applies to the large scale.  Download the entire interview here.


Dr. Shrivastava will be presenting Disposable Membrane Chromatography Systems as a Platform for mAb Purification on Thursday, April 2 at Biopharmaceutical Development and Production Week.  As a reader of this blog,when you register to join us March 30-April 2, 2015, you can save 20% off standard rates when you mention code XB15155BLOGJP! Have any questions? Reach out to me at jpereira@iirusa.com.


Share this article with your social network, just click below to share now!


Thursday, January 29, 2015

BDP Week Football Spectacular: Save 49% when you register to join us at BDP Week!

This Weekend Only: Register for Biopharmaceutical Development & Production Week by Sunday, February 1 with priority code BDP15SB49 and you will save 49% (up to a $1800+ savings) off the standard rates.

Co-Located with:
Single-Use Applications & Flexible Facilities
March 30 - April 2, 2015
Hyatt Regency Resort & Spa 
Huntington Beach, CA
Mention priority code BDP15SB49

BDP Week provides you an immersive 4-day learning and networking experience—that will help you to:
  • • Get focused learning on Single-Use Applications and Flexible Facilities from these two established, co-located events.
  • • Discover technological and scientific advances improving cost, speed and productivity in process development
  • • Gain strategies to avoid pitfalls, maximize efficiencies and alleviate bottlenecks with elaborate coverage of manufacturing technologies for emerging biologics.
  • • Apply new found knowledge gained from 180+ speakers and demo new technologies from 70+ exhibitors for immediate advancements of your process and products.
  • • Connect with 800+ biopharmaceutical development and manufacturing peers to, swap ideas, and generate business outcomes with fun, casual networking functions.

Questions? Email Jennifer Pereira.

*This promotion is only valid January 29- February 1, 2015 only. Offer cannot be applied retroactively to confirmed paying registrants and cannot be combined with any other discounts or promotions. All registrants and guests are subject to IBC approval. 


Share this article with your social network, just click below to share now!


Friday, January 23, 2015

Genetic Engineering: It's Not Frankenstein

Today's guest post comes from Genome Editing Applications sponsor Horizon Discovery.

Genetic Engineering: It's Not Frankenstein
Author: Hannah Murfet (PCQI, BSc). Quality and Regulatory Manager

Genetic engineering often faces unjustified bad press with regard to genetically modified crops, however genetic engineering continues to provide great promise for drug discovery, assessment and production. We must apply care and regulation to allow continued advances to focus of human treatment and not enhancement, science should not allow us to create a monster.

Genetic engineering put simply is the adjustment of the instructions of our cells, the smallest functional unit of life. The genome is the sequence of information required to code for an organism. this consists of a long code represented by 4 letters (G, A, T and C). The sequence of these letters codes for the proteins and how often they are produced. Changes in the coding of these 4 letters take a range of forms from single letter changes, insertions and duplications.

Genetic engineering is routinely applied in medical treatment, particularly with the mass production of human insulin in bacteria since 1982 (1). In this example the gene for insulin was inserted into bacteria, the bacteria then produce insulin protein which can then be purified for medicinal use. The future of this technology has continued with antibody therapy, where immune proteins are engineered and produced for targeted treatment of cancer and autoimmune disease.

Scientists are able to make use of changes in coding to further our understanding of disease models such as cancer, where changes in the 4 letters can lead to changes in the way our cells behave (2). Cell and animal models can be used in early stage drug trials to determine effectiveness and resistance.

The future of genetic engineering takes this a stage further to target the cells in our bodies. This technology makes use of a virus to insert a gene to treat disease where the coding defective, Glybera is the first drug of this kind to be recommended for approval (3). The cost of these therapies is currently high, but the field of genetic engineering is continuing to evolve and new technologies such as CRISPR are being adopted (4).

Right now all the work in this field is creating some positive enhancements for medicine. With careful control and regulation the prospects for drug development and treatment have massive potential, however we must take care of the ethical implications of genetic alteration, particularly anything that may lead to human enhancement - we certainly don't want to create any monsters!

(1) http://www.brighthub.com/science/genetics/articles/21983.aspx

(2) http://www.oapublishinglondon.com/article/607

(3) http://www.nature.com/mt/journal/v20/n10/full/mt2012194a.html

(4) http://www.bio-itworld.com/2014/5/22/advances-genetic-engineering-american-society-microbiology-meeting.html



Genome Editing Applications will take place will take place March 18-19, 2015 in Boston.  Find out more about the program.  As a reader of this blog, you can save 20% off the standard rate when you register to join us and mention code D15223BLG.  

This is co-posted on LinkedIn


Share this article with your social network, just click below to share now!


Thursday, January 22, 2015

Right Drug, Right Time

Today's guest post comes from Genome Editing Applications sponsor Horizon Discovery.

Right Drug, Right Time
Author: Hannah Murfet, Vice-Chair CQI Next Generation Network

“Right first time” is a concept familiar to the quality profession, but it is taking on a whole new meaning since the emergence of personalised medicine. Personalised medicine aims to eradicate an often random and reactive approach to patient care by employing techniques such as genetic testing to ensure treatment is more likely to be effective and safe in a specific patient population.

Traditional approaches to drug treatment generally take a population-wide trial and error approach. That is to say that the drugs used for treatment are known to be generally effective, but their specific effect on an individual patient is often unknown. Drugs are typically tested on large patient populations in order to test for safety and efficacy. As the patient population is seldom uniform, the efficacy is reduced as the drug works well for some and not others. Personalised medicine has the opportunity to change this by allowing us to use the right drug at the right time – a prime example of root cause analysis.

The successes of personalised medicine are staking up, and include genetic testing for breast cancer, chronic myeloid leukaemia and colorectal cancer. One very well-known example is screening for BRCA1 and BRCA2 gene mutations to predict whether a patient needs preventative breast cancer treatment. Other examples include targeted therapy based on chromosome alterations in patients with chronic myeloid leukaemia and KRAS gene mutations used as biomarkers to predict the success of specific drug treatments for colorectal cancer. Seemingly, the possibilities for personalised medicine are endless.

While the upfront costs of personalised medicine are initially higher, they will be reduced in the long term as the cost of quality is reduced by removing the expense of ineffective and repeated treatments. It’s a tremendously exciting time for the pharmaceutical and medical device fields, but I also feel those in the quality profession can take something from this. The application of the right drug, at the right time, has parallels with the work of the quality profession. We aim to use the right tool, the right approach and the right improvement at the right time. So let’s take a ‘personalised medicine’ approach to business improvement. I’m sure the results will be just as powerful for improving quality.

Genome Editing Applications will take place will take place March 18-19, 2015 in Boston.  Find out more about the program.  As a reader of this blog, you can save 20% off the standard rate when you register to join us and mention code D15223BLG.  

This post is co-posted with the CQI Blog.


Share this article with your social network, just click below to share now!


Wednesday, January 21, 2015

ADC emerge as leading cancer treatment option

Antibody Drug Conjugates (ADCs) are an ideal way to target cancer cells while missing the cancer cells.  Two ADCs have jumped to the top of the treamtent list -brentuximab vedotin which treats lymphomia and ado-trastuzumab emtansine which treats breast cancer.

As their success grows, and more therapies using this technology are being developed, finding safe manufacturing methods for ADCs has posed to be the next big challenge. According to BioProcess International, there are four key factors of an ADC that must be in tact to produce a working ADC: the antigen, the targeting antibody, the linker, and the payload. In order to create more drugs at a larger scale, researchers are focusing development methods that reduce heterogeneity and ways to create site-specific conjugations.  Not only that, but finding these two things are some of the next key challenges for scientists:
  • -How to increase clinical impact for tumors that display heterogeneous expression of a target antigen
  • -How to improve outcomes for those ADCs that show promising early efficacy before tumors develop resistance.

What do you see as the next big breakthrough in antibody drug conjugate therapy?

This year at BDP Week, we'll have an afternoon dedicated to New Modalities and Next Generation ADCs – Challenges in Development and Production with presentations from companies including MedImmune, Sutro Biopharma Inc. and CytomX Therapeutics, Inc.  For more information on this session and the rest of the program, download the agenda.  As a reader of this blog, when you register to join us and mention code XB15155BLOGJP to save 20% off the standard rate.


Share this article with your social network, just click below to share now!


Thursday, January 15, 2015

Continuous Processing The Good, The Bad and the Unexpected

Continuous processing is easier said, than done. It promises to make biomanufacturing more viable,
but will it delver?

At BDP Week, industry experts will share the good, the bad and the unexpected to help you reduce manufacturing costs, improve product quality and increase flexibility while reducing risks.

Continuous Processing Programming Highlights Include:
  • • Media Development Strategies for Platform and Late Phase Cell Culture Process
    • -Wenge Wang, Ph.D., Senior Principal Scientist, Bioprocess R&D, Pfizer
  • • Upstream Disposable Technology Supports the Implementation of Continuous Processing
    • -Shaun P. Eckerle, Principal Scientist, Cell Culture Development, Patheon Biologics
  • • Downstream Processing and New Technology for Continuous Chromatography
    • -Maria Ekblom, Senior Project Manager, Chromatography Systems, GE Healthcare
  • • Ultra Scale-Down Characterization Of Bioprocessing Materials for the Early Prediction of the Impacts of Industrial Scale Continuous Centrifugation on the Recovery and Purification of New Therapeutic Candidates
    • -Alex Chatel, Ph.D., Bioprocess Enterprise Fellow, Biochemical Engineering, University College London, United Kingdom
  • • Continuous Chromatography: The Good, the Bad, and the Unexpected
    • -Oliver Kaltenbrunner, Ph.D., Scientific Director, Chemical Process R&D, Amgen
  • • How to Optimize the Perfusion Rate in High Cell Density Perfusion of Chinese Hamster Ovary Cells Culture in Stirred Tank
    • -Veronique Chotteau, Ph.D., Prinicpal Investigator, Researcher, Cell Technology Group, School of Biotechnology, KTH, Royal Institute of Technology, Sweden
  • • Integrated and Fully Continuous Processing of Recombinant Therapeutic Proteins – From Cell Culture Media to Purified Drug Substance
    • -Veena Warikoo, Ph.D., Director, Purification Development, Genzyme
  • • Exploring Options for Achieving Diafiltration in a Continuous Process
    • -Alex Brinkmann, Engineer III, Biogen Idec
  • • ASAP (Automated Seamless Antibodies Purification): Toward a Fully-Disposable Process
    • -Benoit Mothes, Pharm D, Senior DSP Scientist, Sanofi, France
  • • Continuous Downstream Processing: Where Does It Fit?
    • -Moderator: Marc Bisschops, Ph.D., Scientific Director, Tarpon Biosystems
  • • Single-Use Chromatography Platform For Monoclonal Antibody Purification
    • -Renaud Jacquemart, Ph.D., Senior Scientist, Process Sciences, Natrix Separations
  • • Exploring Options for Achieving Diafiltration in a Continuous Process
    • -Alex Brinkmann, Engineer III, Biogen Idec
  • • Processes of the Future : Single Use, Closed and Continuous for Faster, Cheaper and Safer Manufacturing
    • -Sébastien Ribault, Ph.D., Director Biotechnology/Life Science, Head of BioDevelopment Center, EMD Millipore

Plus, do you have new research to share with your industry colleagues? We’re searching for the newest, innovative findings to be presented by our attendees in poster displays at BDP Week. Submit your abstract today.

Now is the time to make plans not attend BDP Week for end-to-end bioprocessing solutions that will help you guarantee reproducible results and manufacturing success.  Register to join us March 30-April 2, 2015 in Huntington Beach, California.  As a reader of this blog, when you register to join us and mention code XB15155BLOGJP, you save 20% off standard rates.


Share this article with your social network, just click below to share now!


Tuesday, January 13, 2015

Single-Use Applications 2015

Join us for Single-Use Applications 2015 to learn how to optimize time-to-market, overcome complex drug product and manufacturing challenges, and ensure successful implementation and integrity of single-use adoption and deployment.

The event features 10 Case Studies and 2 Interactive Q&A Sessions on Today's Most Pressing Single-Use Challenges including:
  • • Ensuring Successful Single-Use Implementation and Integrity: Case Studies from: Amgen and Merck & Co.
  • • Single-Use Implementation and Transfer: Case Studies from: Genentech, Merck & Co. and Public Health England
  • • BPSA Roundtable: Interactive Q&A: The Road Ahead: Issues Impacting the Accelerated Adoption of Single-Use Technologies
  • • Single-Use Considerations for Cell Culture Applications: Case Studies from: NIH and Shire
  • • Single-Use Applications in Upstream Processing: Case Studies from: Shire HGT and KPI Biopharma
  • • Production and Regulatory Considerations for Single-Use: Case Study from: Protein Sciences Corp.
  • • Overcoming Challenges Associate with Particles and Extractables & Leachables: Interactive Q&A: Extractables & Leachables
>> View the Single-Use Agenda
>> View the Full BDP Week Agenda
>> View the Agenda-a-Glance (PDF)

Single-Use Applications 2015 will take place from March 30-31, 2015 in Huntington Beach, CA.  It Flexible Facilities & Biopharmacuetical Development & Production Week is co-located with taking place on March 30 - April 2, 2015.


Share this article with your social network, just click below to share now!


Thursday, January 8, 2015

The Top 10 Ways to Improve Speed, Quality, Efficiency and Compliance | Register this week and present your poster for free!

IBC's Biopharmaceutical Development & Production Week (BDP Week) will take place March 30 - April 2, 2015 at the Hyatt Regency Resort & Spa in Huntington Beach, CA. This year, we’re pleased to announce that it is co-located with Single-Use Applications & Flexible Facilities.

The event offers the most in-depth coverage of bioprocessing topics on the market with 10 Focused Conference Tracks to help you improve speed, quality, efficiency and compliance.  What are our top 10 topics?



1. ADC Development & Production: Explore revolutionary approaches to development, scale up, formulate, and produce next generation ADCs that are more potent, stable, and have dramatically increased therapeutic windows.



2. Analytical Methods & Technologies: Maximize process and product quality, from comparability and characterization strategies to QbD concepts to HCP quantitation and control to aggregation and subvisible particle analysis.



3. Upstream Processing: Increase cell culture productivity, product quality, and efficiency through innovative technologies, platforms, and approaches to streamline development and reduce time to large scale production.



4. Single-Use Applications: Optimize time-to-market, overcome complex drug product and manufacturing challenges, and ensure successful implementation and integrity of single-use adoption and deployment.



5. Downstream Processing: Optimize efficiencies during harvest and purification of high cell density processes, continuous platforms and emerging modalities through the integration of disruptive technologies and methodologies.



6. Flexible Facilities: Novel and adaptable production strategies and solutions for the multi-product-centric biomanufacturing landscape.



7. Manufacturing Efficiencies: Achieve and maintain operational excellence with solutions to the emerging challenges of increasingly diversified portfolios in a global marketplace.



8. Quality and Control: Develop and benchmark protocols with a focused look at the latest challenges, best practices, and future trends for process validation and viral safety.



9. Bispecific Antibody Development & Production: Utilize new molecule design approaches, development strategies, and platform production processes to overcome the unique challenges of this transformative class of therapeutics.



10. Manufacturing Quality & Control: Develop and benchmark quality assurance and quality control protocols to meet compliance expectations for environmental, contamination, and manufacturing controls.


Plus, at BDP Week you have access to meet with the leaders in the industry with more than 165 speakers, 80+ Case Studies, 85+ New Data Presentations, 70+ exhibitors, 80 scientific posters and 800 attendees. This is the only event that can provide you this much in-depth biopharmaceutical development and manufacturing coverage in just 4-days!

Free Poster Offer 
Present your poster for free! Register for BDP Week with code BDP15LIA16 and present your poster for free! This code also includes the 20% discount off the standard rate you receive as a reader of this blog. This offer expires Friday, January 9.

Have any questions? Email Jennifer Pereira.

You can also enter to win a free pass to this year's event.  Head to Twitter and retweet this tweet to enter!


Share this article with your social network, just click below to share now!


Wednesday, January 7, 2015

Antibody drug conjugates and their complexity

ADCs are changing the way we fight cancer. While a few are on the market at the moment, over 200 are in preclinical development and over 30 are currently in clinical trials. Author Ronald A. Rader believes that the market will grow to just under $10 billion within the next 10 years.

With the complexity of antibody drug conjugates and their production, the industry is at an interesting intersection when it comes to their production and disposal.   Among the things that make these drugs extremely complex include hormones, biological toxins. Other challenges presented by author Rader of ADCs include:
  • - Combining and balancing optimal MAb specificity
  • - Handling MAb-linker-drug binding chemistries
  • - Controlling intracellular toxin release
  • - Preventing premature toxin release
  • - Manufacturing with concerns for worker safety and environmental release
How are companies overcoming these challenges?  Read the full article at BioProcess International.

The challenge of ADC development will be extensively covered at Biopharmaceutical Development and Production Week this March. Robert Lutz, Ph.D., Vice President of Translational Research & Development at ImmunoGen will present Clinical Development of ADCs - How are We Doing?, coverign many of the challenges of the production of ADCs. As a reader of this blog, if you'd like to learn more from Lutz and about ADCs, you can save 20% off the standard rate when you register to join us with priority code XB15155BLOGJP.


Share this article with your social network, just click below to share now!


Tuesday, January 6, 2015

Next Generation Protein Therapeutics Summit: Preliminary Agenda

IBC’s 10th Annual Next Generation Protein Therapeutics Summit delivers the very latest results from an ever expanding number of multifunctional molecules in development and offers you the best opportunity to learn from world-renowned academics and industry visionaries who are expanding the frontiers of biologic drugs.  It will take place May 18-20, 2015 in San Francisco, CA.

This Summit is the industry’s most comprehensive conference for sharing new ideas to accelerate the discovery, engineering and development of alternative scaffolds and novel protein therapeutics to create differentiated drugs. By attending, you will gain valuable knowledge from more than 40 presentations showcasing new, unpublished data and exclusive case studies, including lessons learned from the most-recently approved ADCs and Bispecific therapeutics.

Agenda Sessions:
  • • Recent Advances in Discovery Technologies
  • • Development of Immunotherapies
  • • Creative Protein Engineering and Design Approaches
  • • Next Generation Bioconjugates
  • • Unlocking New Biology with Novel Scaffolds and Antibody Fragments as Therapeutics
  • • Addressing Difficult Targets with Protein Therapeutics
  • • Delivery of Proteins
  • • Emerging Methods and Technologies for Screening, Selection and Sequencing
  • • Novel Therapeutic Peptide Development
  • • Bispecific and Multispecifics - New Advances and Approaches
  • • Bispecific and Multispecifics - Engineering Developability into Multi-Functional Protein Therapeutics
  • • Bispecific and Multispecifics - Clinical Case Studies
  • • Molecular Imaging
  • • Aggregation and Immunogenicity

Confirmed Speakers Include:
  • • Peter Senter, Ph.D., Vice President, Chemistry, Seattle Genetics
  • • Jennifer Cochran, Ph.D., Associate Professor of Bioengineering and Chemical Engineering, Stanford University
  • • K. Dane Wittrup, Professor, Chemical Engineering & Biological Engineering, MIT
  • • Gary Starling, Ph.D., Associate Vice President, Biologics Discovery Operations, Merck
  • • Robert Lutz, Ph.D., Vice President, Translational Research and Development, ImmunoGen, Inc.
  • • Robyn Barfield, Ph.D. Group Leader, Bioconjugation, Catalent Pharma Solutions
  • • Dimiter Dimitrov, Ph.D., Senior Investigator, Protein Interactions, National Cancer Institute, NIH
  • • Arne Skerra, Ph.D., Chief Scientific Officer, XL Protein
  • • Dasa Lipovsek, Ph.D., Senior Principal Scientist, Bristol-Myers Squibb
  • • David Urech, Ph.D., Co-CEO and Chief Scientific Officer, Numab, Switzerland
  • • Joachim Feldwisch, Ph.D., Director Preclinical Development, Affibody Ab, Sweden
  • • Catherine Hutchings, Ph.D., Antibody Alliance Management & Strategic Partnering, Heptares Therapeutics Ltd., United Kingdom
  • • Andrew Bradbury, Ph.D., Ph.D., Research Scientist and Team Leader, Los Alamos
  • • Patrick Baeuerle, Vice President, Research; General Manager, Amgen Research GmbH, Germany
  • • Aaron Sato, Ph.D., Vice President of Research, Sutro Biopharma
  • • Volker Schellenberger, Ph.D., President and CEO, Amunix
  • • Zhenping Zhu, MD, Ph.D., Executive Vice President, Global Biopharmaceuticals, Kadmon Corporation
  • • Kaspar Binz, Ph.D., Vice President and Co-Founder, Molecular Partners AG, Switzerland
  • • Olivier Laurent, Ph.D., Vice President, CMC, Ambrx
  • • Steven Jacobs, Ph.D., Associate Scientific Director, Biologics Research, Janssen R&D
  • • Antonin de Fougerolles, Ph.D., Chief Scientific Officer, Ablynx, Belgium
  • • Dragan Grabulovski, Ph.D., Chief Scientific Officer, Covagen AG, Switzerland
  • • Fredrik Frejd, Ph.D., Chief Scientific Officer, Affibody AB, Sweden
  • • Bradley Pentelute, Ph.D., Assistant Professor, MIT
  • • Jean E. Lachowicz, Ph.D., Chief Scientific Officer, Angiochem
  • • Mark Dennis, Ph.D., Principal Scientist, Antibody Engineering, Genentech, Inc.
  • • Gregory C. Ippolito, Ph.D., Research Assistant Professor, Department of Molecular Biosciences, The University of Texas at Austin
This event is taking place on May 18-20, 2015 in San Francisco, CA is co-located with IBC's Bioconjugates: From Targets to Therapeutics and Cell Line Development & Engineering conferences. With these 3 established events, under one roof – you can cross-fertilize with multiple disciplines to gain new ideas to help you propel promising candidates toward commercial success. Find out more about attending all three events with our Best Value All Access Pass.


Share this article with your social network, just click below to share now!


Friday, January 2, 2015

Flexible Facilities 2015

Get a comprehensive look at the flexible, multiproduct centric, biomanufacturing landscape from senior level executives and scientists from biopharmaceutical firms, CMOs, technology providers, engineering firms and regulatory groups. Explore the evolving biomanufacturing landscape and beyond through shared case studies on flexible facility implementations, lessons learned and practical experience.
  • • Non-Classified, Closed and Other Considerations and for Single-Use Implementation
  • • Process and Facility Design Strategies and Considerations
  • • Process Development and Manufacturing Strategies
  • • Design, Management and Implementation Considerations for Flexible Facilities
  • • BPOG Session
  • • Biomanufacturing of the Future
Plus, our speaker list features experts from: Shire, Sanofi Pasteur, EMD Millipore, Texas A&M Center for Innovation in Advanced Development and Manufacturing, Genentech, Development & Production, Public Health England, NNE Pharmaplan, University of Massachusetts Medical School, Biogen Idec, BPOG, GSK Biologicals and more!

>> View the Flexible Facilities Agenda
>> View the Full BDP Week Agenda
>> View the Agenda-a-Glance (PDF)

This event is co-located with Single-Use Applications & Biopharmacuetical Development & Production Week taking place on March 30 - April 2, 2015.  As a reader of blog, when you register to join us and mention code XB15155BLOGJP and save 20% off the current rates!


Share this article with your social network, just click below to share now!


Friday, December 26, 2014

Join us for a Web Seminar: Exploring Purification Boundaries with Cadence™ Inline Concentrator


Date: Wednesday, Jan 28, 2015
Time: 10:00 AM - 11:00 AM EST
Speaker: Chris Forespring, Sr. Manager, BioProcess Engineering , MedImmune
Register to join us.  Mention priority code Webinar_FOB

About the web seminar:
Thorough evaluation of emerging technologies is a key determinant for identifying process improvement opportunities in
existing and future bioprocess facilities. Successful implementation through process coupling and/or elimination of non-value added processing steps could result in both novel facility-fit solutions with alternative processing options and provide major cost savings at clinical and commercial scales.

In this context, a collaborative study has been undertaken to demonstrate the use of Cadence™ Inline Concentrator (ILC) linked to several potential processing steps such as perfusion, pre-capture chromatography, in-process volume reduction, and UF/DF. ILC is a disposable, self-contained, and easy to use, single-pass tangential flow filtration (TFF) device. The feasibility and performance of ILC modules were successfully evaluated and demonstrated over a wide range of feed streams at varying concentrations and process temperatures.

Participants will learn:
  • -How the ILC technology is an important addition to the process development toolbox for platform process development.
  • - How the ILC can remove constraints in existing facilities and increase the flexibility of manufacturing.
  • - Specific ILC applications with industrial biomolecules and the impact on the existing processes through detailed end-user case studies.


Share this article with your social network, just click below to share now!


Tuesday, December 23, 2014

It doesn’t show signs of stopping… Let is sale! Let it sale! Let it sale!

‘Tis the season! As our holiday gift to you, here’s 30% off the standard rates when you register for Pharma and Healthcare events from now through Wednesday, December 31! Use the code “Holiday30” at checkout.

These events were specially selected for your interests:

19th Annual Drug Delivery Partnerships
January 29-30, 2015 in Boca Raton, FL
> The largest strategic drug delivery and device partnering community to strike your next big deal, catch up on the future of innovative technologies, and stay FDA compliant.
- Find out more about the event.
- Register to join us.

ePharma
February 24-26, 2015 in New York, NY
>Charge up your marketing campaign with ROI-infused initiatives and embody the newest technologies that bleed success.
- Find out more about the event.
- Register to join us.

IBC’s Biopharmaceutical Development & Production Week (BDP)
March 30 – April 2, 2015 in Huntington Beach, CA
>Join us to gain strategies to avoid pitfalls, maximize efficiencies and alleviate bottlenecks with elaborate coverage of manufacturing technologies for emerging biologics. Visit the website for full details.
- Find out more about the event.
- Register to join us.

Partnerships in Clinical Trials
April 22-24, 2015, 2015 in Boston, MA
>Accelerate your speed to market by leveraging new partners, new technologies, and new business models at the must-attend clinical event of the year!
- Find out more about the event.
- Register to join us.

IBC’s 17th Annual TIDES
May 3-6, 2015 in San Diego, CA
>The #1 forum for CMC, Clinical and Discovery Scientists to Accelerate Oligonucleotide and Peptide Product Development. Visit the website for full details.
- Find out more about the event.
- Register to join us.

Have any questions? Email Jennifer Pereira.

Happy Holidays!


Share this article with your social network, just click below to share now!


Thursday, December 18, 2014

Striving to find new development methods for chemically defined media

In a recent article at European Business Review, Francesc Gòdia took an in-depth look at how to scale up the production of cell culture media in a safe way.  Reliability of supply, variability in performance and risk of viral infection has caused manufacturers to find new ways to develop these cell cultures.  The race is on and three alternatives to traditional methods are insulin, trasferrin, and albumin.  To examine the opportunities, Gòdia designed an experiment that screened for optimal compounds and another that optimized their concentration.  Read the results on page 36 of the European Biopharmaceutical Review.

This March, Gaurav Chauhan, M.S., Associate Scientist II, Cell Culture and Fermentation Sciences, MedImmune, will be on hand to share the presentation A Mathematical Model: Predict How HTST Impacts Media Treatment and Resolve Scale-Up Issues at Biopharmaceutical Development and Production Week.  For more information on this session and the rest of the program, download the agenda.  If you'd like to join us March 30-April 2, 2015 in Huntington Beach, California, as a reader of this blog when you register to join us and mention code BDP15JPLA2, you can receive the current lowest rate available to the event!


Share this article with your social network, just click below to share now!