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Considering Cell Culture Automation in Upstream Bioprocess Development

With the increasing importance of biologics in today’s pharmaceutical market, throughput and efficiency are crucial in developing a production cell line. Cell culture automation can be a good solution for high-throughput and labor-intensive areas of a development process. Because of the cost of the investment, there are many factors to be considered before committing to a purchase.

In this paper, Tim Gryseels, a senior scientist at Pfizer, discusses the important steps in identifying and purchasing cell culture automation, and how the automation process can reduce costs and increase throughput, efficiency and consistency.

Mycoplasma In-Process and Lot Release Testing: To PCR or Not to PCR

by BPI Contributor

Mycoplasma are the simplest self-replicating prokaryotes, and they are frequent contaminants of cell cultures. Mycoplasma infection can affect nearly every cell culture parameter and result in decreased quantity or quality of product, inconsistency of manufacture, or possible adverse effects in recipients. Because of this, detection of mycoplasma is extremely important; but because of their small size, limited turbidity produced in culture, the wide diversity of mycoplasma species, and other factors, detection of mycoplasma can be challenging.

Some common culture methods of mycoplasma detection for cell bank and raw material release, in-process, and lot release testing have a long turnaround time (minimum 28 days). For most biological products, the mycoplasma culture test is the rate-limiting step for lot release. This white paper examines alternate methods of mycoplasma detection with shorter turnaround times, such as polymerase-chain-reaction (PCR)—based assays.