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 post. The 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?

Dr Nick Hutchinson

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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Single-Use Standardization on the agenda for BPSA at BPI Boston, 2015

“The BioProcess International Conference has always been a good venue for the Bio-Process Systems Alliance to work with industry to identify issues and define next steps”, say Todd Kapp, BPSA Board Member and Sales & Market Development Manager of Parker domnick hunter – North America.

The Bio-Process Systems Alliance is a leading trade association which facilitates the implementation of single-use bioprocessing through networking opportunities, creating a safe harbour for dialogue between industry and business leaders, providing forums for end-users and suppliers to work together and producing best practice guides.

“The BPSA has become a recognized leader in the industry for bringing users and suppliers of single-use technology together to discuss and educate one another on best practices and guidelines for implementation”, Kapp observes.

Single-Use Standardization

Along with other industry organizations such BPOG, PDA, ASTM and ASME BPE they will be participating in a Town Hall Forum Discussion on Single-Use Standardization at the BioProcess International Conference andExposition 2015 in Boston.

Standardization of single-use assemblies is an objective for many biomanufacturing organizations as they seek to reduce inventories and working capital. Historically, standardization exercises within the processing industries have been somewhat protracted affairs as various players try and agree on the preferred solution to standardize upon.

Todd Kapp (Parker domnick hunter & BPSA Board Member) 

EPICSolutions™ for Single-Use Technologies

Successfully implementing single-use technologies into biomanufacturing processes raises a number of issues that end-users are having wrestle with including the safety of the materials used, whether they shed particles or can maintain integrity and an increased reliance on the quality systems of their suppliers including their change notification procedures.

To help end-users address these issues the BPSA will be leading or contributing to sessions along the theme of EPICSolutions™ which stands for Extractables, Particles, Integrity, Change and Sustainability and was the main theme of the BPSA Summit held in Washington DC last week.

Kapp explains, “BPI has been and continues to be a great way for BPSA to communicate with the market and spread the word about the value it brings to industry”.

Without doubt BPI will be a richer learning experience for bioprocess engineers on their journey to implement single-use technologies by the inclusion of the BPSA in the program.

Dr Nick Hutchinson

nick.hutchinson@parker.com

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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This Week in BioPharma: 7/5-7/10 - $80 million dollars in pharma packaging and more

Med device manufacturers are being pushed toward taking partial responsibilities for faulty products alongside with insurers and U.S. hospitals. In the competitive environment, often pressed by insufficient demand, suppliers slowly move toward taking a risk and providing additional guaranties to gain an edge on the marketplace. Reuters, UK reports that in recent years there were billions of dollars paid to settle court claims of unsatisfied and at times unable to covers additional costs of treatment customers. The emerging trend is pushing medical device makers to not just cover the cost of broken or defective parts but to become accountable for health outcomes.

Vaccine products are said to reach $40 billion in sales by 2020. According to a recent report by the Tufts Center for the Study of Drug Development this number has tripled comparing to 2005. Research and development of vaccine products are on the rise. It is explained by many factors include the healthcare system and reluctance of healthcare providers to deliver long-term care for patients as well as continuous advances in cancer treatment research. The "Vaccine products in the R&D pipeline have more than tripled since 2005" report also suggests that while vaccine product makers are in the development phase at full speed, one of the obstacles they may face is distrust that consumers express toward vaccination as a general trend.

The packaging market in pharmaceutical industry in projected to reach $80 million dollars in value by 2020. Packaging of pharma products aims to protect the products from external influence, extend it shelf-life as well as cover all legal aspects. The pharmaceutical packaging market is rapidly growing due to steady progress in drug and vaccine development, and therefore the need of appropriate up-to-date packaging that responds to ever-changing demands of capricious consumers persists.

Not true they say, that biotech industry belongs to the West Coast - a biotech company from NY (Albany) was awarded more than $1 million in grants from the National Institutes of Health and the National Science Foundation. HocusLocus is focusing its attention on developing a cure against HIV and Ebola through the "switchable" mechanism that allows to switch from one gene to another one potentially killing cancer cells and viruses.


About the author: Ksenia Newton, a Digital Marketing Assistant at IIR USA, Pharma Division, who works on various aspects of the industry including social media, marketing analysis and media. She can be reached at knewton@iirusa.com

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The continuous production of biopharmaceutical drugs

If there is one hot topic in biomanufacturing at this moment in time it has to be continuous processing. Journals and websites are feeding, what appears to be, the biopharmaceutical industry’s almost insatiable appetite for information on the subject. The interest is reflected in the deals made within the industry such as Pall Corporation's acquisition of the BioSMB technology platform from Tarpon Biosystems and Repligen Corporation’s 2014 acquisition of Refine Technology. Refine developed and manufactured the Alternating Tangential Flow (ATF) filtration device which can be used to retain mammalian cells within bioreactors while continuously harvesting product.

With such a focus within biopharma upon continuous processing it is no surprise that a significant portion of the Bioprocess International 2015 Conference, agenda is allocated to talks on this subject. Before we look at some of those talks in more detail, however, we should review the industry drivers that appear to be taking the bioprocess sector away from the batch process paradigm and moving it towards a continuous manufacturing future.

The four key industry drivers behind continuous bioprocessing

In an excellent article, Veena Warikoo from Genzyme, a Sanofi company, and co-workers published in 2012 on the “Integrated Continuous Production of Recombinant Therapeutic Proteins” (Biotech Bioeng, 2012;109: 3018-3029). Four key drivers are given as:

1.    the need for biopharma companies to flexibly accommodate large-volume and orphan drugs potentially within the same facility

2.    the need for production platforms to accommodate both stable monoclonal antibody and less stable recombinant protein therapeutics

3.    the need to make rapid adjustments in production capacity in line with the dynamics of market demand

4.    increasing cost pressures, not least, due to the growing pipeline of biosimilars in development

The benefits of bioprocess intensification

Warikoo and her co-authors explain that the conversion for batch to continuous manufacturing has occurred in many other industries in the past and has led to the following benefits:

1.    steady-state operation

2.    small equipment size

3.    high volumetric productivity

4.    streamlined process flows

5.    low cycle times

6.    reduced capital costs

Too conservative for continuous?

Bioproduction is renowned for being a conservative endeavour. Despite the business deals and industry drivers are we really ready for continuous biomanufacturing or is the noise in the media simply empty hyperbole? Will continuous processing become the rule or remain the exception? Join the debate by letting us know your thoughts.

 

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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How to improve your monoclonal antibody harvest step using flocculation with smart polymers

In my last post (Might the sun be setting on process-scale chromatography for the purification of biopharmaceuticals?) I discussed how the trend of increasing bioreactor productivity at a near exponential rate has outstripped developments in packed-bed chromatography leading to bottlenecks in downstream processing.

Addressing the need for purification methods with higher throughputs will be the subject of presentations at the BioProcess International 2015 conference, however, seeking ways to eliminate chromatography steps is not necessarily the only solution to the problem of throughput-constraints in purification.  

Flocculation and cell culture harvests

Ken Kang from Eli Lilly and Company is scheduled to present on “Monoclonal flocculation with smart polymers for efficient clarification of high titer cell cultures and improved removal of impurities”. In 2013, Kang and collaborators from both Eli Lilly and Company and EMD Millipore published an article in the journal ‘Biotechnology and Bioengineering, 2013;110:2928-2937’ describing an alternative harvest process for monoclonal antibodies (mAbs) using the stimulus responsive polymer, benzylated poly(allylamine) as a flocculent followed by depth filtration.

Highly productive bioreactor processes also typically generate both high cell densities and levels of impurities that put additional pressure on purification trains. Although a relatively low resolution purification technique, flocculation can be used to remove considerable amounts of cells, host cell proteins and DNA in a quickly and cheaply. This decreases the burden on chromatography columns allowing a reduction in the number of cycles that must be performed and increasing the usable lifetime of resins. An additional benefit is that flocculation process are relatively easy to fit into existing equipment configurations without having to perform a whole-scale redesign of manufacturing facilities.

Residual levels of impurities in Protein A chromatography eluates

The process described in the article was not only high yielding and improved the clearance of cell debris but  also reduced aggregated product, HCP and Nucleic Acids. The burden on polishing chromatography steps was considerably reduced as the investigators were able to show that once the clarified cell culture filtrate was purified by Protein A chromatography the impurities in the eluate were so low they potentially met drug substance requirements. Crucially the team were able to demonstrate the clearance of residual polymer using fluorescence tagging.

Could flocculation improve your antibody harvest step?

The results from studies on flocculation such as this one seem both to present a path forward to reduce the impact of downstream bottlenecks while also being readily implementable. Flocculation processes seem relatively easy to develop, scale and operate without requiring sophisticated or expensive new equipment. What do you see as the benefits and challenges associated with this bioprocessing technique?

About the Author: 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.

https://uk.linkedin.com/pub/dr-nick-hutchinson/0/b38/37 

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Might the sun be setting on process-scale chromatography for the purification of biopharmaceuticals?

Browsing through the program for BPI Boston 2015 I was really excited to see Abhinav Shukla is chairing a session in the Recovery & Purification track on novel approaches to non-chromatographic purification. The session will be on Tuesday afternoon starting at 1.25pm.

Like I explained in last week’s blog the subject it’s a subject that is particularly to my heart as it’s the field I worked in as a fresh engineer in my first role upon completing my doctorate.

Bottlenecks in downstream processing

Packed-bed chromatography is, of course, the workhorse of large-scale therapeutic protein purification. The selectivity of chromatography steps especially when operated together as part of an integrated downstream purification train allows very high levels of drug purity to be achieved ensuring patient safety.

The trade-off from a method like this which has such a great ability to resolve different molecular species to give a pure product is that capacity and throughput can be compromised. This was not such an issue during the early days of the industry but as it has developed and bioreactor productivity has increased at a near exponential rate the reliance on chromatography has arguably lead to bottlenecks in purification processes.

The cost of Protein A chromatography

For some within the industry the greatest concern is around Protein A affinity chromagraphy which is an extremely common capture step for monoclonal antibodies once harvested from bioreactors. The extremely high selectivity of Protein A resin means it has a somewhat lower capacity than some alternatives and its high cost of manufacture is reflected in its cost. Though significant advances have been made in Protein A resin technology over the past 20 years there is still significant interest in finding a suitable alternative. The cost of such a consumable means it is imperative biomanufacturers must take care when using and storing the resin to maximize its lifetime.

 Novel methods for therapeutic protein purification

Elastin-like polypeptides (ELP) are fascinating biopolymers that will reversibly transition from soluble molecules to insoluble form at relatively low temperatures. A modest temperature increase will allow an ELP-tagged protein to precipitate out of solution where it can be purified from contaminants using a traditional solid-liquid separation technique such as centrifugation or hollow fibre microfiltration. Resolubilization into a desired solvent or buffer will occur when the temperature of the suspended purified protein is reduced. A great description of the method for purifying ELP-tagged proteins without recourse to chromatography is described in a publication from Ashutosh Chilkoti and others of Duke University.

Author of the 2013 article ‘Emerging Challenges to Protein A’ (BioProcess International. Oct 1, 2013) Pete Gangnon is scheduled to present at the session and hopefully will be sharing more insights into highly innovative antibody purification process he describes in the article. Gangnon highlights two techniques used in combination with one another, firstly chromatin-directed clarification followed by an approach called steric exclusion chromatography which uses polyethylene glycol and hydrophilic particle surfaces. These techniques used with a Capto Adhere chromatography step to complete the purification process gave yields of over 80% while reducing host cell protein levels to <1ppm and aggregate to <0.1%.

What is your experience?

Have you tried non-chromatographic purification methods? How successful was it? Do you think that packed-bed chromatography may have had its day?

Nick Hutchinson

LinkedIn (https://uk.linkedin.com/pub/dr-nick-hutchinson/0/b38/37)

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BPI Boston Announces its 2015 Program

By: Dr. Nick Hutchinson

Hello, welcome and thank-you for visiting our new blog aiming to provide insights and provoke discussion ahead of, and around, the Bioprocess International Conference and Exhibition which will be at Hynes Convention Center, Boston, MA  between the 26^th and 29^th October 2015.

Many of you will know the event of course, but for those of you who haven’t yet had the pleasure of attending this event previously, it is one of the leading bioprocessing conferences in North America and indeed attracts delegates (including myself), presenters and exhibitors from all over the globe.

If you take a moment to review the conference program you’ll see the reason why. The conference will have 6 tracks covering up- and down-stream processing, manufacturing strategies, analytical and formulation & quality, early phase biologics. This year there will be a new track on drug product manufacturing & fill-finish processing. Each session is chaired by a leader in their field who pulls together presentations addressing real industry problems that delegates can learn from and theb take this information back to their organizations to help them develop, manufacture and commercialize their biopharmaceutical products.

In addition, delegates can attend the pre-conference symposia on Monday, October 26 and will have access to the ever popular BPI Theater featuring, amongst many other things, an “Ask the Regulators” Open Forum and a Fireside Chat session focussed on the key question of how we can accelerate biopharmaceutical development and manufacturing?

There will be a Town Hall Forum Discussion addressing the crucial question of Single-Use Standardization and feature representatives from a range of industry bodies including BPOG, BPSA, PDA, ASTM and ASME/BPE.

Of course, if you need them, there are many other reasons to attend the conference such as over 150 exhibitors and over 100 posters. The opportunities to network with your industry peers are huge.

To help you prepare for the event I’ll be posting about selected topics and key themes from the conference to provide you with background and insights on the subject matter so that you can come prepared to develop collaborations and engage in discussions.

Next blog I’ll be taking a look at a subject close to my heart which is novel approaches for non-chromatographic purification processes. My first role out of college was precisely in this area in order to reduce bottlenecks in downstream processing caused by ever higher product titres being achieved upstream. I hope you’ll provide feedback and share your experiences for the benefit of other delegates.

About the Author: 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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This Week in BioPharma: 6/8-6/12

Top news from the biopharmaceutical industry this week:

In the future, treatments tailored to patients: Cambridge biotechs such as Genzyme Corp. and Alnylam Pharmaceuticals Inc. are developing personalized treatments for rare genetic disorders like Gaucher and Fabry disease. Vertex Pharmaceuticals Inc. of Boston is turning out a portfolio of medicines that attack the life-threatening lung disease cystic fibrosis by targeting specific genetic mutations.

Getting to the red zone in biopharma R&D: For some time after the FDA put its new breakthrough therapy designation together for the industry, there was a good deal of back and forth among industry analysts over whether the BTD would make much of a difference. You don't hear much of that kind of carping much these days, and a new report from EP Vantage illustrates why.

Study: biopharma innovation outpaces tech overall: Innovation in the biotech and pharmaceutical industries outpaced the combined activity of 12 technology sectors between 2009 and last year, according to a report released today by Thomson Reuters.

The 25 most influential people in biopharma in 2015: A lot of people make news in the biopharma business. Few of them are influential. Influence, simply put, is the ability to make your mark in such a way as to get other prominent people in this business to rethink the way they do business.

Alder Biopharmaceuticals' new drug promises migraine relief:  Shares of clinical-stage biopharmaceutical company Alder Biopharmaceuticals Inc. are up more than 100 percent from the lows they made in late April this year and are currently trading near their all-time highs.One of the main reasons for this surge has been the promising data released by company last month for its migraine treatment drug.

Cancer clinical trials expert to assist Regen BioPharma, Inc. in addressing FDA questions: The goals  of the collaboration is to  address  questions  posed by the FDA regarding  Regn BioPharma, Inc.'s planned  Phase I/II clinical trial assessing safety with signals of efficacy of the dCellVax gene silenced dendritic cell immunotherapy for treating breast cancer and to modify the existing Investigational New Drug application in order to maximize the probability  of clinical trial success.

Merck Millipore develops compaction technology for biopharma: Merck Millipore, the life science business of Germany-based Merck, has developed a new technology that compacts dry powder cell culture media into granules, accelerating solubility and improving flowability and handling. The compacted media are, therefore, more convenient to use, allowing biopharmaceutical manufacturers to further optimize their upstream processes.

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Social Flash Sale! 25% off the Standard Rates to BPI China and Antibody Engineering China!

Register with code SAVE25 to activate your 25% discount off the standard rates to IBC’s BioProcess International Conference and co-located Antibody Engineering China Conference taking place August 12-13, 2015 in Shanghai, China.

Visit the BPI China Website Here: http://bit.ly/1FsH7tP

Visit the Antibody Engineering China Website Here: http://bit.ly/1F1xYVQ

This 25% discount limited-time offer expires on Tuesday, May 26^th. Register using the below links and use the code: SAVE25

Click Here to Register for BPI China: http://bit.ly/1FsH7tP

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Don’t miss out on the most comprehensive biologics event in Asia covering the entire spectrum of antibody, protein and biotherapeutic development from discovery and preclinical/clinical to process development and manufacturing.

Hear from the below dynamic keynotes on:

• Multi-specific Biologics
  Robert Friesen, Ph.D., Janssen R&D, LLC (Johnson & Johnson), USA

• Antibody Lead Discovery & Optimization
  Rene Hoet, Ph.D. Bayer Healthcare, Germany

• Analytical Control from Phase I to Post Approval
  Sherry Guo, Ph.D. F. Hoffmann-La Roche Ltd., USA

• And more!

Download the BPI China Brochure Here: http://bit.ly/1PATAUp

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Activate your 25% savings now with code SAVE25! Offer expires 5/26

Click Here to Register for BPI China: http://bit.ly/1F1xYVQ

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Qualifications, rules and regulations:

Offer cannot be applied retroactively to confirmed or pending registrations from today's date and prior. 25% discount cannot be combined with any team discounts or other promotions and/or discount offers. Discount is only valid from May 22– May 26, 2015. All registrations are subject to IBC approval.

Best,

The BPI China and AntiBody Engineering China Teams

@ibcusa

#BPIChina

#AntibodyEngChina

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BDP Week 2015: Conventional vs Single-Use Facilities Panel Discussion

By: Maribel Rios, Managing Editor of BioProcess International

On Wednesday, 1 April 2015, the Biopharmaceutical Development and Production Week meeting held a Q&A session between attendees and a selected panel, moderated by Adam Goldstein (Genentech, a member of the Roche group). Panelists included Nuno Fontes (Boehringer Ingelheim), David Fritsch (Fritsh Consulting), Francis Kobina Insaidoo, PhD (Merck Research Laboratories), Chris Antoniou (Biogen Idec), and James D. Vogel (The BioProcess Institute). The panel first discussed the merits of moving to an all-single-use facility, such as Amgen’s facility in Singapore as opposed to continuing to use a stainless-steel-based facility and making modifications with single-use systems. Questions and discussion focused on the following:

·         Does building a complete single-use facility make sense? The panel agreed that there are some processes (e.g., early stage, smaller volume, pilot studies) in which the complete or near-complete use of single-use systems make sense. Larger-volumen(>2,000 L), commercial-scale, and dedicated processes would be more susceptible for stainless-steel systems.

·         How does cost of goods and other economic factors play a role? The panel agreed that manufacturers must examine all factors carefully, including timelines for building a facility. Other concepts, such as ballroom-style or modular facilities also can reduce timelines.

·         Are there single-use solutions for high cell density and high-titer processes? And are there ideas for addressing the limitations of single-use mixing of such processes? The panel responded that work on “loop” systems is ongoing through companies such as HyClone/Thermo/GE.

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BDP Week 2015: Extractables and Leachables

By: Maribel Rios, Managing Editor of BioProcess International

On Tuesday afternoon, 31 March 2015, the single-use track of the BioPharmaceutical Development and Production (BDP) Week meeting in Huntington Beach, California, focused on the challenges associated with particles and extractables and leachables (E&L). Bobbijo V. Redler, PhD (Merck & Co., Inc)  began by defining the terms and the different types of E&L studies, including controlled extraction studies (screening), simulation studies, leachables testing (using methods validated for registration), and routine monitoring (also using validated methods). She reviewed simulated study designs, the use of various analytical techniques for E&L studies, and efforts of the E&L team of the BioPhorum Operations Group (BPOG).

James Vogel (The BioProcess Institute) presented on the work of the Bio-Process Systems Alliance (BPSA) on its 2014 particulates technical guide, “Recommendations for Testing, Evaluation, and Control of Particulates from Single-Use Processing Equipment.” The 12-chapter compendium is targeted for both end users and supplies of single-use components and systems. The session ended with a roundtable moderated by Redler. Panelists included Weibing Ding (Biogen Idec), James Vogel, and Michael Rupperto, PhD (Material Needs Consulting). The session consisted of a Q&A with attendees. Various issues were discussed, including the following:

·         Whether the BPOG extractables protocol published last year (Ding W, et al. Standardized Extractables Testing Protocol for Single-Use Systems in Biomanufacturing. Pharm. Eng. Nov-Dec. 2014) actually is a “best practices” document and if it truly can be used for “comparability.” Panelists said that the protocol does provide some flexibility, the document is a “step forward,” and that ASTM (Association for Standards Testing and Materials) and USP (US Pharmacopeia) Chapter <661.3> work is ongoing.

·         Whether it is better to discontinue use of a component is easier than to conduct continuous monitoring for extractables. The panel answered that the decision is often a matter of time and cost and that the material may have unique properties that are needed.

·         How to determine a threshold for extractables information and the definition of BPA-free. The panel emphasized the importance of smart material selection, paying close attention to materials, including secondary packaging, and continually assessing risk.

·         Whether the BPOG protocol (above) should actually be more rigorous. The panel mentioned that not many company are conducting in-process leachables testing for process equipment, reminding attendees that suppliers are responsible for extractables tests and end users are responsible for leachables testing. The general intention is to get single-use implemented quickly. 

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BDP Week 2015: BPSA Roundtable

By: Maribel Rios, Managing Editor of BioProcess International

The Bio-Process Systems Alliance (BPSA) presented a single-use applications roundtable on Monday, 30 March 2015, at the BioPharmaceutical Development and Production (BDP) Week meeting in Huntington Beach, California. Mark Petrich, PhD (Merck & Co., Inc.) moderated the panel consisting of Jerry Martin (Pall Corporation), Jeffrey Carter, PhD (GE Healthcare), James Vogel (The BioProcess Institute), and Todd A. Kapp (Parker-Hannifin Corporation). Martin started with a historical review of the BPSA, a trade organization formed in 2005 and now consisting of 46 member companies (suppliers and end users) whose goal is to “advance single-use worldwide and facilitate implementation of single-use technologies.” 

Carter and Vogel then reviewed BPSA’s active and recent projects, consisting of the following:

·         Single-Use Manufacturing Component Quality Test Matrices (currently under final review and should be available for the BPSA Annual Summit, 13-15 July 2015, in Washington DC)

·         Change Notification Practices (currently in the initial stages of documenting)

·         Extractables (currently continuing collaboration with other organizations such as ASTM, ASME-BPE, and USP)

·         Quality Agreement Template for Single-Use Biopharmaceutial Manufacturing Products (published July 2014, currently soliciting feedback from users of the template, with possible future revisions)

·         Particulates Guide, a 12-chapter compendium addressing why particulates are an issue, how to identify them, and so on (currently soliciting further input)

The roundtable concluded with Knapp presenting the future focus of BPSA, including the annual summit and its new scholarship fund.

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Introducing the FDA/CMS Summit for Biopharmaceutical Executives

Join us for the 10th Annual FDA-CMS Summit, for biopharmaceutical executives, December 11-12, 2014 in Washington, DC. Our keynote speakers and panels will take a deep dive into each of these topics, and more. You'll leave better able to make strategic decisions on issues such as:

• The commercial outlook for biopharma under the new health care exchanges

• Updates on the latest drug review statistics from the Office of New Drugs and industry's experience under the new review "Program"

• The future of drug safety at FDA - both for the increasingly popular rare disease drugs as well as new treatments for large primary care markets like obesity and diabetes

• What's in store for the reauthorization of PDUVA VI, and a preview of what's to come as industry and FDA take a second look at BsUFA and GDUFA.

• Coming changes to Medicare Part D and what CMS has in store for the prescription drug benefit

• What the mid-term Congressional elections will mean for the biopharma industry.

 
Speakers Include:

o Janet Woodcock, MD, Director, Center for Drug Evaluation and Research (CDER) Food and Drug Administration (FDA)
o John Jenkins, MD, Director, Office of New Drugs, Food and Drug Administration (FDA)
o Leah Christl, Associate Director, Biosimilars Program, Office of New Drugs Food and Drug Administration (FDA)    
o Gerald Dal Pan, MD, Director, Office of Surveillance & Epidemiology, Food and Drug Administration (FDA)
o Jim Robinson, President, Astellas Pharma US    
o Sumant Ramachandra, MD, PhD, MBA, SVP & Chief Scientific Officer, Hospira
o Robert Clark, VP, US Regulatory Affairs, Novo Nordisk    
o Francois Nader, MD, CEO, NPS Pharmaceuticals
o Karen Jones, VP, Global Head of Oncology Regulatory, Genentech    
o Chris Garabedian, CEO, Sarepta
o David Beier, Partner, Bay City Capital    
o John McHutchison, MD, Executive Vice President, Clinical Research, Gilead
o Mark McClellan, MD, PhD, Senior Fellow and Director, Health Care Innovation and Value Initiative, Brookings Institution    
o Niall Brennan , Acting Director, Office of Enterprise Management, Centers for Medicare & Medicaid Services (CMS)
o Tamara Syrek Jensen, JD , Deputy Director, Coverage and Analysis Group, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services (CMS)    
o Mark McCamish, MD, PhD, Global Head Biopharm.& Oncology Injectables Development, Sandoz International GmbH
o Karen Jones, VP, Global Head of Oncology Regulatory, Genentech    
o Chris Garabedian, CEO, Sarepta
o David Mott, General Partner, Biopharmaceutical Investments, New Enterprise Associates (NEA), Former CEO, MedImmune    
o Steven Nissen, MD, MACC, Chairman, Department of Cardiovascular Medicine, The Cleveland Clinic Foundation

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