Thursday, July 2, 2015

Single-use technologies enable closed-system bioprocessing

The benefits of single-use technology
Single-use technologies provide a number of benefits over traditional hard-piped equipment and facilities. Five key benefits are described below:
1.    Increased flexibility which allow system changes to be readily implemented during process development, scale-up or while a process is in routine operation.
2.    Reduced risk of contaminations either between batches of the same product or between batches of different products manufactured in the same facility
3.    Reduced or eliminated need for steam-in-place and clean-in-place generating equipment
4.    Shorter facility start-up time
5.    No need for cleaning validation
However, an additional benefit that is attracting an increasing amount of attention is the utilization of single-use technologies to allow closed-system processing.
Why perform closed system processing?
Closed-system processing in single-use technology might be an attractive option for a range of biomanufacturers with different motives. These could include:
·         Cell Therapy manufacturers operating short and simple processes with no method of sterilizing their end-product
·         Vaccine and viral vector manufacturers who find that sterile filtration processes significantly reduce process yields of these large biologics
·         Continuous manufacturers operating processes for many weeks at a time and wanting to avoid a build-up of bioburden within their equipment
·         Any biomanufacturer looking to cut facility running costs by reducing the air handling requirements within processing suites
·         Small-scale, localized, temporary bioproduction facilities manufacturing vaccines close to outbreaks of infectious diseases where local infrastructure is limiting.
Single-use developments allowing for closed-system processing
Pre-irradiated, assembled manifolds and containers are available from a range of suppliers. Operators simply need to install the product-contact consumable and are then ready to start processing.
Single-use bioreactors have been available for some time and are designed, of course, to minimise the risk of microbial ingress. Similarly, single-use mixers and bioprocess containers can be connected to and from with sterile connectors. Sterile disconnectors allow ancillary tubing to be removed while maintaining a sterile boundary around the product. Thermoplastic elastomer tubing can be welded to create flowpaths without compromising sterility and can be sealed to close containers.
The sterilization of product streams and necessary process solutions such as culture media and buffers can be achieved using gamma-irradiated membrane filter capsules. Remember, however, that simply used a sterilizing-grade filter in itself does not guarantee sterility and that validation of the sterile filtration process must be performed to ensure a bioburden-free environment.
For a while, closed-system processing was held back by a lack of suitable technologies for the purification of biologics largely because the need had not been identified or the technology not available. The company I work for has now launched a single-use TFF which avoids the need to clean and store cassettes. At a conference I attended last week Dr James Rusche, Senior VP Research & Development at Repligen described a single-use Protein A chromatography column that had been gamma-irradiated to prevent the build-up of bioburden during continuous harvesting operations.
Of course, because a technology can be gamma-irradiated does not mean it is qualified as sterile, however, if the drivers are there then customers will push vendours to generate this data for all single-use technologies allowing closed-system processing to become a reality for a growing number of processes.
Have your say
Are you driving towards closed system processing? What technology would, if available, make operating in this way more feasible?

Want more on single-use technologies? Meet leading companies in the space at BioProcess International Conference & Exhibition this fall in Boston. Here are the sponsors and exhibitors that will be attending:

Eppendrof
Finesse Solutions, Inc.
GE Healthcare Life Sciences
JSR Life Sciences
Levitronix,
Meissner Filtraion Products
Optek-Danulat Inc.
Qosina
Repligen
Saint-Gobain
SpectrumLabs.com
Pneumatic Scale Angelus
ILC Dover
CPC
Pall Life Sciences
TEK
Nordson Medical
Thermo Fisher Scientific
Beckman Coulter
em-tec Flow Technology (LP)
Kuhner Shaker Inc.
Entegris
WR Grace

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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Celebrate July 4th with 30% Off Select IBC Events!


Take advantage of this special July 4th offer and save 30% off the standard rates to IBC’s Cell Therapy, Bioprocessing & Commercialization, Immuno-Oncology, BioProcess International and Antibody Engineering & Therapeutics when you register by Monday, July 6th.

Cell Therapy, Bioprocessing & Commercialization - Save 30% by using the code XFLASH30 when you register. Visit the event website | Register

Immuno-Oncology - Save 30% by using the code XFLASH30 when you register. Visit the event website | Register

BioProcess International Conference & Exposition - Save 30% by using the code BPIJULY4 when you register.Visit the event website | Register

Antibody Engineering & Therapeutics - Save 30% by using the code AE201530 when you register.Visit the event website | Register


Qualifications, rules and regulations: 
Offer cannot be applied retroactively to confirmed or pending registrations from today's date and prior. 30% discount cannot be combined with any team discounts or other promotions and/or discount offers. Discount is only valid from July 2– July 6, 2015. All registrations are subject to IBC approval. Discount cannot be applied to the Academic/Government Rates.


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Wednesday, July 1, 2015

8th Annual Biorepositories and Sample Management Summit: Summer Sale!

From now until Saturday, July 4th we’re celebrating America’s birthday with blowout summer savings. You can save an additional $100 off of current rates for IIR’s Biorepositories and Sample Management Summit* with code SummerSaleBL. Revolutionize your business model and fine-tune your preservation procedures at the most interactive biobanking community event of the year! Learn more about the event here.


*Discounts cannot be applied retroactively. All registrations are subject to IIR approval.


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Tuesday, June 30, 2015

Conscious Commercialization and Agile Biobanking: Part II

Conscious Commercialization and Agile Biobanking

A Three Part Series in Biobank Business Planning: Part II
By Lisa B Miranda, President and Chief Executive Officer, Biobusiness Consulting Incorporated
6/30/2015

PART II

Start with Part I.

One of my key recommendations around strategic business planning for biobanks is to take time to develop tools for success. This includes a putting together a financial roadmap, plan, process and mechanism for recovering costs. Though many biobanks were created with monies from publicly available grants and internal stakeholder funding, the days of “wine and honey” are long gone. With grant applications converting to contract mechanisms, funding in limited supply and requirements for return on stakeholder investment increasing, monetization of existing bioresources through cost recovery is now essential. Willing acceptance of this reality in tandem with timely cultural change about ways to garner revenue makes all the difference in the outcome.

So, let’s return to the topic of conscious commercialization and how this fits in:
What do you mean by the term “conscious commercialization”?

Conscious commercialization begins with thinking about how business rules can meet the needs of the entire stakeholder community and still fulfill one’s bottom line. It incorporates a well-defined and thoughtful process about how to monetize an entity - i.e. biospecimen core facility. Groups that focus on finding creative, mixed and/or alternative mechanisms to generate revenue are essentially commercializing a percentage of their operations.

The term, “conscious commercialization” emanated from an idea in the business world disseminated by Whole Foods Market co-founder John Mackey and Raj Sisoda, PhD. The strategy centers on the belief that both business and capitalism are inherently good and that one can build on the foundations of capitalism, (e.g. voluntary exchange, entrepreneurship, competition, freedom to trade and the rule of law.) According to the theory, for a company to really be healthy it must incorporate elements of relationship building i.e. trust, compassion, collaboration and value creation.

Mackey and Sisoda’s philosophy is built on four pillars: higher purpose, stakeholder orientation, conscious leadership and conscious culture. These pillars (seen below in Figures 1 & 2) also intuitively apply to business conside
rations in the biobanking world, what we refer to as “biobusiness”:
Mackey and Sisoda' phylosophy behind biobanking and biobusiness

The four pillars adapted for biobank business planning (“biobusiness”):

    Higher Purpose (a.k.a. Mission): Recognizing that every biobank has some mission that defines its creation and higher purpose. While its purpose may not necessarily be to generate profit, it does bring in dependable sources of funds and/or revenue. This revenue can drive the mission forward. By sustainability focusing on its mission, the biobank can inspire, engage and energize its stakeholders.

    Stakeholder Orientation: Recognizing that the capability to achieve innovation in medicine, life science, and biobanking is interdependent and reliant on the human foundations of business. A biobank needs to create tangible value with and for its various stakeholders (e.g. funders, customers, employees, vendors, investors, scientific and medical communities, etc.). Real time recognition of this fact leads to a healthy business system.

    Conscious Leadership: Biobanks are created and guided by leaders – people who see a path and inspire others to travel along the path. Conscious Leaders understand and embrace the Higher Purpose (mission) of business and focus on creating value for and harmonizing the interests of the business stakeholders. They recognize the integral role of culture and purposefully cultivate Conscious Culture.

    Conscious Culture: The core values, principles and practices – underlying the social fabric of the biobank’s business infrastructure and key activities, which connects the stakeholders to each other integrating the purpose, people and processes that comprise the value of the organization.

      Figures and text adapted from the book “Conscious Capitalism: Liberating the Heroic Spirit of Business” by John Mackey and Raj Sisoda, PhD and website reference: www.consciouscapitalism.org

      The take home for me, at least from reading about their idea, is that commercialization to some degree while not for everyone can be a positive activity. It can be leveraged successfully to meet your business goals while still serving your biobank’s organizational mission. One can inherently create more value by applying validated business strategies that clearly define the goals of your organization (e.g. biobank) while working cooperatively with your stakeholders to help drive economic viability. We can utilize the free market economy as an opportunity to drive progress forward. Biobanks and their stakeholders (including industry) play synergistic roles in innovation. We all need each other to thrive.

      Tune in on July 7th for part three of the series when I present observations from peer case studies demonstrating how conscious commercialization and agile biobanking strategies can drive success in biobank utilization.

      About the Author:
      Lisa Miranda is President & Chief Executive Officer of Biobusiness Consulting Incorporated, a biobanking and biotechnology commercialization advisory with global reach based in the Greater Boston Area. She has 25 years of experience, complimented with 14 years of higher education including nine years of graduate study at the University of Pennsylvania (UPENN). She began her career in clinical care and community based research in local hospitals and then moved to clinical and epidemiology research. She spent over 14 years in research at UPENN conducting clinical and investigator initiated trials to bring new drugs and clinical therapies to market, testing and helping develop emerging medical/surgical technologies, diagnostic devices and evaluating novel biotechniques. In 2005 she launched and directed her first core facility a biospecimen resource for UPENN called TTAB. Recruited for her first consulting job in 2007 as a contractor for the United States National Institutes of Health, National Cancer Institute’s Biorepositories and Biospecimens Research Branch (BBRB), she expanded her consulting practice full time in 2008. Known worldwide as a biobanking and clinical research subject matter expert, much of her work focuses on: biobank business planning, strategic development of biospecimen research applications and biotechnology commercialization. Prior biobanking and biotechnology commercialization Executive positions have included: Vice President, Strategy and Business Development for MEMS based Biotechnology Company Bluechiip, Vice President, Strategic Alliances and International Biobank Relations, Trans-Hit Biomarkers, and Technical Director, Tumor Tissue and Biospecimen Bank Core Facility, UPENN. For more information email Lisa: lisabmiranda@biobusinessconsulting.com or download her 2014 podcast on the future of biobanking.



      http://bit.ly/1C5wUpg


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      Friday, June 26, 2015

      This Week in BioPharma: 6/22-6/26

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

      Organic Industry Wants Biotechnology Regulated By Process, Not Product: About 40 activist organizations that usually can be counted upon to rally with the organic industry against genetically engineered (GE) plants and animals weighed in with a letter to USDA’s Animal and Plant Health Inspection Service (APHIS) for the federal regulation of biotechnology products. Monday’s letter, which included some food company signatures as well as those from organizations, called for APHIS to “regulate biotechnology based process, not product.” The letter also called for adding noxious weeds to biotechnology regulations, which the signers want regulated to the “fullest extent.”

      Saudi Engineer Invents Unique Biotechnology: Saudi engineer and inventor Ibrahim Alalim has 
      come up with a new biotechnology to break down the composition of any animal fat, crude oil or any petrochemical product. “This biotechnology involves a liquid extract from vegetables that could be instrumental in coming up with products that will be useful in cleaning utensils, floors and marble,” Alalim said.

      These are the Fortune 500's Fastest-Growing Pharma Companies: The pharmaceutical industry has been rocked in recent years by a confluence of patent expirations of blockbuster drugs, increasing competition from generics and new governmental and industry efforts to control costs the world over. That’s made growth prospects for many pharma companies a risky and uncertain proposition. 

      The Importance of Real-World Data to the Pharma Industry: For years, randomized controlled trials (RCTs) were considered the gold standard for generating clinical data on efficacy and safety to support product registration and subsequent prescribing. Recently, analysts and academics have discussed the promise of real-world data (RWD), signalling its potential to contribute to improved health outcomes. Data's role in normal clinical practices, or in settings that reflect the reality of healthcare delivery, is likely to become increasingly important in ensuring that medicines are accepted by national policymakers and are adopted into practice.

      Is the FDA Too Tough on Medical Device Makers?: In a new paper, “Regulating Innovation with Uncertain Quality: Information, Risk, and Access in Medical Devices,” Wharton health care management professors Matthew Grennan and Robert Town shed light on the question: Are the FDA’s medical device regulations too hard, too soft, or just right? Town recently sat down with Knowledge@Wharton to discuss their findings.

      House Ignores Veto Threat and Backs Repeal of Medical Device Tax: The House on Thursday easily backed repeal of a tax on the medical device industry. But President Obama has threatened to veto the bill, which would add more than $24 billion to the deficit over the next 10 years. With not all House members voting Thursday, that chamber's 280-140 vote fell one vote shy of a veto-proof majority to repeal the tax, which helps pay for the expansion of health insurance under the 2010 Affordable Care Act.


      Short Sellers Become More Focused on Big Pharma: The short interest data has been released for the June 15 settlement date. Pharmaceutical companies are usually involved in a lengthy process in getting their drug candidates to market through clinical trials. There is a fair amount of risk involved, should a study come back negative or a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be big upside.


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      Thursday, June 25, 2015

      Conscious Commercialization and Agile Biobanking



      A Three Part Series in Biobank Business Planning
      By Lisa B Miranda, President and Chief Executive Officer, Biobusiness Consulting Incorporated
       

      Part I:

      Forward-looking market statements tout biobanking as a burgeoning and bountiful global market. For example, the company Vision Gain published in September 2014 that “the biobank world market will reach $22.7 billion in 2018.  In particular, rising demand for biobanked samples for use by pharmaceutical companies in preclinical research stimulates that market.” Despite the potential business opportunity for biobank growth and market expansion, economic viability remains a prevalent pressing issue for biobanks globally.  


      So, why aren’t all biobanks thriving if the market earning potential is there? Well, that is a longer conversation. However, the short answer, based on my expertise, is that the biobanks who are thriving are doing so because they are readily implementing key business success factors into daily practice.   


      Based on a review of sustainability case studies I conducted last fall, the first of these critical success factors is the recognition that sustainability is a legitimate imminent financial concern. No one is immune. Longevity is not necessarily an indicator of sustainability. It’s not unreasonable to say this because in today’s economic climate, we observe both notable well established as well as new biobanks dealing with sustainability issues. As John F. Kennedy said, “Change is the law of life and those who look only to the past or present are certain to miss the future."  


      Once you recognize that sustainability is crucial, time is off the essence. Proactive strategic planning is imperative and should follow the same logic as beginning your retirement planning: it’s never too early. The sooner you make a financial roadmap, the better. 


      In fact, in some cases new biobanks may be able to be more agile and adaptive in this regard, since their business model and infrastructure may not be predetermined and thereby malleable. This is particularly true for implementation of a cost recovery model.  As many Biobank Directors will convey it can be problematic to successfully recover costs for a sample, product and/or service if it was historically provided free of charge. It also can be more difficult to identify and understand cost components later. In an economic survey of over 100 biobanks last year conducted for a client we found this to be true. Web based applications (e.g. US NIH/NCI BBRB biobank economic modeling tool (the BEMT) and CTRNET user fee calculator) can be useful tools for positive steps towards developing an informed model for cost recovery. 


      Driving culture change around financial planning can be crucially expedited by securing organizational support and commitment to devote resources towards evaluating the need to do things more sustainably. This can often be a catch-22 situation however as one often needs to show a reasonable business plan, market value and/or a path to impact to garner unwavering support. The work is worth it though as biobanks with organizations that support a culture of change towards cost recovery and sustainable development typically experience compounded success in this area. 


      I can relay happily that this is a valid observation from my past life as a Core Facility Director.  I also see this frequently firsthand with the organizations I work with, both public and private.  These issues are not necessarily sector-specific - they merely present differently. My first attempt at a business plan in Academia for my bioresource required a second revision, but it was well worth the time. And looking back dozens of business plans later, I try to use those lessons learned with clients in real time. And as Mark Sanborn so wisely said, "Your success in life isn't based on your ability to simply change. It is based on your ability to change faster than your competition, customers and business."  


      Tune in June 30th for part two of the series when we discuss how  “conscious commercialization” is another critical factor for success in business planning.


      8th Annual Biorepositories and Sample Management Summit

      About the Author:
      Lisa Miranda is President & Chief Executive Officer of Biobusiness Consulting Incorporated, a biobanking and biotechnology commercialization advisory with global reach based in the Greater Boston Area. She has 25 years of experience, complimented with 14 years of higher education including nine years of graduate study at the University of Pennsylvania. She began her career in clinical care and community based research and then moved to clinical and epidemiology research. She spent over 14 years in research at the University of Pennsylvania conducting clinical and investigator initiated trials to bring new drugs and clinical therapies to market, testing and helping develop emerging medical/surgical technologies, diagnostic devices and evaluating novel biotechniques. In 2005 she launched and directed her first core facility a biospecimen resource for UPENN called TTAB. Recruited for her first consulting job in 2007 as a contractor for the United States National Institutes of Health, National Cancer Institute’s Biorepositories and Biospecimens Research Branch (BBRB), she expanded her consulting practice full time in 2008. Known worldwide as a biobanking and clinical research subject matter expert, much of her work focuses on biobank business planning, strategic development of biospecimen research applications and biotechnology commercialization. Prior biobanking and biotechnology commercialization. Executive positions have included Vice President, Strategy and Business Development for MEMS based Biotechnology Company Bluechiip, Vice President, Strategic Alliances and International Biobank Relations, Trans-Hit Biomarkers, and Technical Director, Tumor Tissue and Biospecimen Bank Core Facility, UPENN). For more information email Lisa: lisabmiranda@biobusinessconsulting.com or download her 2014 podcast on the future of biobanking.


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      Monday, June 22, 2015

      Antibody Engineering & Therapeutics Preliminary Agenda is Now Available


      Preliminary Agenda is Now Available for Download!
       
      IBC's 26th Annual Antibody Engineering & Therapeutics meeting is returning to San Diego, CA on December 7-10, 2015. 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.

      We’re so excited about how this year’s program is shaping up that we wanted to rush you the preliminary agenda so that you have enough information to take advantage of the early registration discount of up to $650 when you register by Friday, June 26. PLUS! Save an extra $100 with the code D15172BLOG | Total savings of $750! Register here.

      This year's program includes an impressive collection of world-renowned and highly-published academic and industry scientists, who will be sharing the latest science, strategies and preclinical/clinical development efforts covering these areas:

      • Bipecific antibodies: new technologies and applications
      • Antibody effector functions
      • Getting to reproducibility in research and diagnostic antibodies
      • Antibodies to harness the cellular immune system
      • Antibody targets: target, target, target...it's all about the target
      • Immunotherapeutic antibody mechanisms
      • Antibodies for orphan indications
      • Computational antibody design
      • Antibody therapeutics for non-cancer indications
      • Clinical advances in antibody targeted therapeutics
      • New concepts for prodrugs
      • And More!

      Don't miss out! Register today to take advantage of the early-bird savings of up to $750. This is the lowest rate of the year and expires on Friday, June 26th!

      Click Here to Register Now >>

      Be Sure to Use Code: D15172BLOG

      See you in San Diego!


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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;110:2928-2937describing 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.
      Join me at #BPIconf


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      Thursday, June 18, 2015

      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
      Join me at #BPIconf





















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      Wednesday, June 17, 2015

      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 26th and 29th 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.
      Join me at #BPIconf


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