September 2012

From the Editor

    Another successful BioProcess Theater at the Biotechnology Industry Organization’s annual BIO Conference and Exposition (Boston, MA) led BPI into the summer on a high note. In fact, a number of our presentations this past June attracted standing-room–only audiences in the exhibit hall’s BioProcess Zone, with steady attendance throughout the three days of the event. The BioProcess Theater creates a forum for discussion of technologies and applications for both exhibit-hall–only attendees and full-conference registrants. Presenters enjoy long conversations afterward…

Thermo Fisher Hosts a Series of BioProcessing Seminars

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…

The Votes Are In!

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…

Creating a Corporate Compliance Program

    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…

QbD for Biologics: Learning from the Product Development and Realization (A-MAb) Case Study and the FDA OBP Pilot Program

    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…

Legacies in Bioprocessing

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.…

Production of a Viral-Vectored Vaccine Candidate Against Tuberculosis

    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…

Novel Single-Use Sensors for Online Measurement of Glucose

    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…

Advancements in Processing That Optimize Samples for Future Research

    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…

Global Marketplace

  Product Development   Service: Contract development and manufacturing Applications: Clinical- and commercial-scale complex biologics Features: Therapure Biopharma specializes in biologics development, scale-up, and manufacturing. At its 130,000-ft2 CGMP facility in Toronto, Ontario, Canada, the company offers cell-line, process, and analytical development; product manufacturing and testing; and aseptic fill–finish and lyophilization. It has >20 years of experience working with mammalian and primary cell cultures, whole blood, and plasma sources. Contact Therapure Biopharma www.therapurebio.com     Capsule Filters   Product: CM…