Author Archives: John R. Godshalk

eBook: Vaccines — COVID-19 Invigorates a Stagnant Industry

by and

The SARS-CoV-2 novel coronavirus has galvanized what was a stagnant and oligopoly-run vaccine industry. In this inaugural BioProcess Insider eBook, the first of four to be published in 2021, founding editor Dan Stanton explores economic and technical conditions that until now have hampered innovation in vaccine development and discouraged market entry for emerging biotechnology companies. Leveraging commentary from vaccine industry experts and analyzing the range of emerging vaccine modalities, Stanton surveys how industry responses to the COVID-19 pandemic are fostering…

February 18, 2021

Do We Need Separate Regulations for Advanced Therapies?

by

Before we had the 21 CFR 1271 regulation for tissue therapies, the US Food and Drug Administration (FDA) had determined that regenerative medicine was exceptional enough to warrant its own regulations for good manufacturing practice (GMP). Since 2001, the tissue industry has adapted to those new rules while the FDA stepped up enforcement over time. When a cell or tissue product is regulated under 21 CFR 1271, its specific regulations apply before the general regulations for biologics and drugs. But…

January 31, 2020