September 2012

Thermo Fisher Scientific wrapped up its North American series of BioProcessing Technology Seminars in June 2012 in North Carolina. Over two months, the company and local biomanufacturers hosted six all-day events at different venues focusing on cell culture media design, single-use systems, bioreactor technologies, and performance optimization. Agendas included interactive presentations from industry experts and typically ended with a tour of a local bioprocessing facility. On 21 June in Cambridge, MA, Eric Langer (BioPlan Associates) kicked off the fifth meeting in the series by reviewing the current state of cell culture processing and of the biopharmaceutical industry in general. Results of his company’s 9th Annual Report and Survey of Biopharmaceutical Manufacturing indicated that the industry is growing at a pace of 15–18%, fueled by higher expression titers and growing interest in biosimilars/biobetters. “Outsourcing has increased overall but is slowing,” said Langer. Investments have increased, w...

On 15 August 2012 BioProcess International announced the 36 finalists for the 2012 BioProcess International Awards — Honoring a Decade of BioProcess. Finalists were determined through an independent judging process, and the results were tabulated and certified by Deloitte & Touche, LLC. To view the names of the finalists and descriptions of their industry contributions, please visit http://awards.bioprocessintl.com/finalists — or read the special 20-page award finalist insert in BioProcess International’s September supplement, The Official Pre-Event Planner of the BPI Conference & Exhibition (which you have received with this issue). The 2012 BioProcess International Awards recognize the outstanding products, services, partnerships, and people that have had the greatest impact on upstream processing, downstream processing, and manufacturing. Awards Dinner and Ceremony: On Tuesday, 9 October 2012, at the BioProcess International Conference & Exhibition, BPI will host a special, closed-door awards r...

Regulatory compliance is an evolving concept that must be flexible enough to adapt to both a company’s unique business climate and to changing regulatory circumstances. Although standard operating procedures (SOPs) are a compliance tool and can and should be strongly recommended, they cannot become the end of a process. Compliance is not a set of standards or procedures that sit on a shelf until something goes wrong. Instead, compliance requires thought in creating a code of conduct and in setting up a process to allow for internal complaints and to test a company’s rate of success or failure. Anything less is doomed and — in a worst-case scenario — will encourage fraud and severely affect a company’s reputation and financial bottom line. Compliance Is Driven By Statutes and Regulations The biopharmaceutical industry has many federal laws, regulations, and guidance documents. Among these are the False Claims Act; the Foreign Corrupt Practices Act; the Food, Drug and Cosmetic Act; the anti-kickback law; th...

Cosponsored by CASSS (an international separation society) and the FDA, the 23rd CMC Strategy Forum was held in Bethesda, MD, on 19–20 July 2010. For the third time, this forum explored the topic of quality by design (QbD) for biologics. The first such forum was held in July 2007 and focused on establishing a general understanding of QbD terminology and concepts. In July 2008, the second discussed approaches for submission of QbD data and associated regulatory implications. Building on those previous QbD forums, this third forum extended the discussion from “what” to “how.” The program committee intended to cover detailed implementation strategies and practical key QbD elements that are readily achievable in the short term. In addition, this forum would combine key learning from two important QbD industry–FDA collaborations: the A-MAb Case Study and the FDA OBP Pilot Program. The pilot program is still in its early stages but nonetheless provides concrete examples of the types of exchange of ideas between...

Bioprocessing is full of legacies. Our remote ancestors discovered fermentation: microbial magic that transformed fruit to wine and grain to beer. Building on the work of Edward Jenner and others, Edward Ballard systematically reinfected cattle to make vaccines. Louis Pasteur revolutionized both fermentation and vaccination by showing that different microbes caused fermentation and spoilage (saving wine and beer production from disastrous batch contamination), establishing the germ theory of disease, and using that knowledge to develop new vaccines against endemic infections. Another legacy (from Paul Ehrlich’s “magic bullet” concept) led to development of horse antitoxins — and later, antibody therapeutics. Deep-tank fermentation of penicillin mold enabled commercial-scale antibiotic production just in time for World War II. Separation of plasma from blood enabled battlefield transfusions, and after the war, extraction of proteins from plasma produced breakthrough treatments for hemophilia. The massive p...

Vaccines are among the most efficacious and cost-effective human health interventions available. They provide protection against a surprisingly broad spectrum of infectious diseases. Notable recent successes protect against human papillomavirus (Cervarix and Gardasil vaccines from GlaxoSmithKline and Merck, respectively) and rotavirus (Rotarix and RotaTeq vaccines from GlaxoSmithKline and Merck, respectively). However, generating reliable sterilizing or therapeutic immunity is still not possible against a number of latent and chronic pathogens that especially affect people in developing countries. Among those agents are Mycobacterium tuberculosis , human immunodeficiency virus, hepatitis C virus, and the Plasmodium protists that cause malaria. Protection against such complex pathogens may require activation of cellular immunity, a compartment of the human immune system that most conventional vaccines usually fail to target. An exception to that rule are live attenuated vaccines, but the approach is una...

According to an FDA guidance document, process analytical technology (PAT) tools “are intended to support innovation and efficiency in pharmaceutical development” ( 1 ). The agency encourages manufacturers to use a PAT framework for developing and implementing effective innovative approaches in development, manufacturing, and quality assurance. The sensors described here are one possible response to the requirement of systems by analyzing and controlling critical cultivation parameters with real-time process measurements. Working Principle Glucose was measured using a #CITSens Bio sensor (C-#CIT) ( 2 , 3 ). It uses an enzymatic oxidation process and direct electron transfer from glucose to the electrode (anode) by a chemical wiring process. By contrast with other enzymatic glucose sensors, it works without cross-sensitivity to oxygen. To separate the sensor from the cultivation medium, a dialysis membrane is cast over the sensing head, which is delivered ready-to-use (gamma-irradiated and integrated into...

Many factors contribute to the quality of biospecimen collections, and most are not mutually exclusive. How we assess the value of a biosample at the time of collection may be very different from at the time of analysis, which can be (and often is) an event in the distant future. To help ensure quality and create a sample resource that is not easily depleted, both novice and experienced “biobankers” can follow some general sample life-cycle management principles to retain the maximum value of their collections. Sample Collection and Management Optimized management of research sample assets is best achieved through a comprehensive sample life-cycle management approach. The key stages of this life cycle are planning, collection, transport, bioprocessing, protection, retrieval, and disposal. The most effective process for managing research samples guides each stage with standard operating procedures (SOPs) focused on optimizing the current and future value of each sample asset. By developing an understanding...