Newsletter | June 9, 2021

06.09.21 -- Robust CHO Cell Expression Platform For High-Quality Biomanufacturing

Aseptic Filling Operations: Keep In-House Or Outsource?

The advancement of small, aseptic filling equipment that fits on a benchtop seems like a great entry into an operation that typically requires automated filling lines in large, dedicated portions of a cleanroom facility. However, the manual operation of these systems poses dramatic sterility risk to the drug product and major challenges from a quality perspective.

Robust CHO Cell Expression Platform For High-Quality Biomanufacturing

Rapid development of a high-quality cell line is vital to any biomanufacturing project, but some of the industry’s most-used processes may be inadequate to help companies meet their timelines. How developers approach the fundamental steps can define their core biologics capabilities and keep projects on track.

Case Study: Developability Assessment Of Three Therapeutic Antibodies

The developability evaluation comprises in silico analysis and a series of in vitro assays for the drug candidates, providing information about the integrity, purity, aggregation, thermostability, charge heterogeneity, glycosylation, poly reactivity, potency, stability over low pH and accelerated storage conditions, and potential PKPD profiles.