The Biopharmaceutical Emerging Best Practices Association (BEBPA) hit the scene in September 2008 with its inaugural Bioassay Conference in Berlin, Germany. A not-for-profit association, BEBPA (www.bebpa.org) is managed by the biopharmaceutical scientific community for the benefit of the biopharmaceutical scientific community: companies, regulators, and clinicians. BEBPA provides an open international forum for the presentation and discussion of scientific issues and problems encountered in the biopharmaceutical community. The purpose of this open discussion is to promote development of innovative approaches and…
2009
Using Innovation to Drive Competitive Advantage
Figure 1: () STOCKXPERT (WWW.STOCKXPERT.COM) After spending decades as the “sleepy†segment of the biopharmaceutical industry, vaccines are now seen as one of its highest growth segments. Major pharmaceutical companies — Novartis AG (www.novartis.com) and Pfizer, Inc. (www.pfizer.com), for example — are aggressively entering this area. Those already in it are expanding capacity and increasing business development activity. Indeed, access to the vaccines business was a major driver of Pfizer’s acquisition of Wyeth Pharmaceuticals (www.wyeth.com) (1). Several factors…
Maintaining Product Titer While Replacing Undefined Components in a CHO Culture System
Proteins, hydrolysates, and lysates of plant or yeast origin are commonly used in cell culture media for large-scale manufacturing processes for human biotherapeutics. Lot-to-lot variability in the composition of such constituents is well established and can affect multiple biological performance indicators. Our goal was to replace an undefined, protein-containing medium with a chemically defined medium (meaning the chemical structure and concentration for each component in a formulation is known). Such a formulation should be free of protein and…
Rethinking Media Performance
Fetal bovine serum (FBS) was — and in many cases still is — the supplement of choice to maintain the viability of mammalian cells in culture. However, there are considerable limitations to its use. In the early days of cell culture, the issues surrounding serum were mainly its variable performance and the potential to contaminate cultures with fungi, viruses, and bacteria. Early attempts to produce a serum-free medium (SFM) were academic exercises that usually relied on the use…
Preparing Bachelors of Science to Work in Bioprocessing
People employed in production and development for life science industries not only need solid knowledge of the scientific bases of modern biotechnology. They also have to be familiar with the working conditions and regulations applicable when working in the field of bioprocessing. Academic curricula in biotechnology and related fields such as bioprocess engineering traditionally prepare students for careers in basic research at public institutions such as universities or research institutes. Students typically study cell biology, biochemistry, genetics, molecular biology, bioinformatics,…
Global Marketplace
Automated Chromatography Product: Tecan Freedom EVO liquid handling workstation Applications: Resin and condition screening, bioreactor monitoring, sample preparation Features: Atoll RoboColumns miniaturized columns are prepacked with a resin of choice in a 96-array SBS format and integrated on a liquid handling robotic workstation. Eight columns are processed together for highly reproducible chromatographic separations. Fraction volumes ≥25 µL can be collected, providing sufficient data points to construct a chromatogram. The entire process can be automated, from…
ZAP-CHO: A Powerful New CHO Cell Culture Supplement
Figure 1: ZAP-CHO enhances performance of mammalian cell culture by optimizing cell growth and reducing apoptosis, leading to higher antibody production yield. It achieves these performance advantages in commercial media, especially chemically defined media and serum– or animal-component–free media. Because ZAP-CHO is defined and free of animal components, it is an ideal additive for cell culture media formulations. ZAP-CHO is an important breakthrough in mammalian cell culture operations. Previously, the performance seen with ZAP-CHO required the use of hydrolysates, FBS…
Risk Mitigation and Quality by Design (QbD) Enhancement Through Raw Material Characterization
Interruptions in bioproduction pose serious setbacks for biopharmaceutical companies. Shipping delays, performance variability, quality unknowns, and regulatory issues can delay time to market and ultimately depress a producer’s financial results. Unforeseen variability in process parameters has led the US Food and Drug Administration to insist that biopharmaceutical manufacturers find ways to ensure batch quality of a drug product during manufacture without relying solely on finished product characterization. This challenge is daunting, considering the large number of raw materials required for…
Althea Technologies, Inc.
While CMOs have traditionally been used to play a critical role in the manufacture of drug product, Althea has evolved beyond being a role player to a strategic development and manufacturing partner that can drive value to a client’s product or product candidate. As drug development costs are always increasing, a properly integrated development and manufacturing scheme can significantly decrease development time and expense, while increasing the probability of clinical success and product differentiation. To allow clients to leverage such…
A Dedicated Contract Development and Manufacturing Organization Focusing on the Delivery of Advanced Biologics for Customers Worldwide
Angel has provided contract development and GMP manufacturing services for recombinant proteins, antibodies, and vaccines since 2001. Responding to market demand, Angel has also built an impressive track record delivering advanced (live) biologics comprising cell therapies including stem cells, cellular vaccines, and bacteriophages. Angel is one of very few European companies providing specialist GMP manufacturing support of these products for international clients. Comprehensive Solutions Angel offers vertically integrated manufacturing solutions reducing risk, cost, and timelines for clients. We believe that…