By Wayne Koberstein, Executive Editor
Speaking with Paul Stoffels is like continuing a long-ago conversation with the late Paul Janssen. A generation younger than the original Janssen company founder, Stoffels now has responsibilities similar to his former boss and mentor, but for a much larger and more complex company now under the Janssen name.
By Milton Boyer, President, OSO Biopharmaceutical Manufacturing
The changing regulatory environment is shaping a new paradigm between drug sponsors and contract manufacturing organizations (CMOs). One key aspect is demonstrated quite nicely in a case study from February 2012 (read it here), when the FDA issued a warning letter to a contract manufacturing organization.
By Brent Bushnell, Bioprocess Applications Specialist, Colder Products Company
This short, detailed Q&A provides information about combination connections and explains their use in single-use bioprocessing. It offers a guide on how single-use systems can be designed to integrate the combination connectors and discusses applications that benefit from utilizing them.
By Brandy Nunez; Brian Canna, MBA; and Jessie Ni, Ph.D.
Irvine Scientific specializes in developing and manufacturing cell culture media for bioproduction. To ensure the utility of the medium, CHO cell lines are tested for density, viability, and productivity.