Upstream Processing

Recommendations for Extractables and Leachables Testing

Extractables and leachables from disposable manufacturing systems must be addressed as part of process validation. Extractables are compounds that can migrate from a material into a solvent under exaggerated conditions of time and temperature. Leachables are compounds that actually do migrate into a drug product formulation under normal processing conditions. All materials have extractables and potentially have leachables. When properly evaluated, both are easily addressed and rarely lead to disqualification of a disposable component. PRODUCT FOCUS: ALL BIOLOGICSPROCESS FOCUS: MANUFACTURINGWHO…

Comparing Shaker Flasks with a Single-Use Bioreactor for Growing Yeast Seed Cultures

Pichia pastoris is a species of methylotrophic yeast that is widely used for protein expression both in academia and the biotechnology industry. A number of properties make it suited for this task (1). Pichia has a high growth rate, and it can grow on simple, inexpensive media. It can also be grown in either shaker flasks or bioreactors, which makes it suitable for both small-and large-scale protein production. PRODUCT FOCUS: Yeast-expressed recombinant proteinsPROCESS FOCUS: ProductionWHO SHOULD READ: Manufacturing and process…