Figure 1: ()
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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 are driving this change. Newly introduced vaccines are generating blockbuster revenues. Wyeth’s Prevnar accounts for nearly $3 billion of the company’s annual revenues, and Sanofi Pasteur’s Menactra (
www.sanofipasteur.com
) is approaching $1 billion. Concerns over influenza and bioterrorism and the potential for stable markets — both governmental and private — have made vaccines a more predictable business. An increasing recognition of...
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 any other components of direct animal origin (
1
). Adapting cells from medium containing hydrolysates and proteins to a chemically defined medium can be challenging because the cells must alter their gene transcription to adapt to the new conditions. However, the benefits of a defined, consistent, and predictable manufacturing process is often worth the investment of time and money. We developed a chemically defined medium and proceeded to optimize it for both g...
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 of purified or semipurified extracts of serum (or other biological material) to replace the growth factors and hormones normally present in it (which were necessary to maintain cell viability). Although such early “serum-free media” were more defined, they still contained animal-derived agents and were in many cases very expensive to use.
In recent years, the scale of mammalian cell culture manufacture has increased to cope with the large-volume demands of the next generation of protein-based therapeutics. In the biopharmaceutical ...
+1People 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, biochemical engineering, and scientific writing and documentation. Graduates from such programs often find themselves missing skills necessary for working in industry. Such crucial skills that are generally not trained in universities include experience with general and specific working conditions (such as professional project management); a knowledge of standards and regulations; an understanding of economics and markets...
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 buffer preparation and column equilibration to column regeneration, providing results quickly with minimal sample consumption.
Contact:
Tecan Group Ltd.
www.tecan.com/parallel
Shake-Flask Reader
Product:
SFR shake-flask reader
Application:
Small-scale microbial cultivation and cell culture
Features:
The shake-flask reader measures oxygen and pH in up to nine shake flasks simultaneously to ensure optimal growth conditions. This wireless s...
