Newsletter | November 27, 2019

11.27.19 -- Congressional Testimony: Stop Targeting U.S.-Based API Manufacturers

From The Editor
Congressional Testimony: Stop Targeting U.S.-Based API Manufacturers
By Louis Garguilo, Chief Editor, Outsourced Pharma

A representative for U.S.-based CDMOs recently testified before Congress regarding the fact 80% of our API is manufactured overseas. If you ask me, they picked the right guy to hear from. “The irony is the same biopharma companies that come to me for clinical material don’t want to go to India and China because of quality issues, but then their API gets manufactured there anyways,” said Edward Price, President & CEO, SEQENS N.A.

Featured Editorial
New EMA Requirements On Nitrosamines: What ALL Pharma Needs To Know
By Barbara Unger, Unger Consulting Inc.

The EMA recently issued two new publications containing information on nitrosamines for marketing authorization holders (MAHs). Every MAH and manufacturer of chemically synthesized APIs and resulting drug products should carefully read the new EMA expectations on potential nitrosamine contamination.

Achieve Quality Through A Continued Process Verification Program
By Peiyi Ko, Ph.D., KoCreation Design LLC

Continued process verification (CPV) is not only required for companies but also is a good investment in product quality and setting the foundation for continuous improvement. 

Industry Insights
Anticipating The Formulation Challenges Of Complex Molecules
Article | Thermo Fisher Scientific

Due to the increasing complexity of today’s API molecules, formulation problems are arising with greater frequency, delaying development and burdening developers with unanticipated and heavy costs.

It Depends: The Real Answer To The Single-Use Or Stainless-Steel Question
Article | Samsung BioLogics

During the past decade there have been innumerable and contentious comparisons between stainless-steel and single-use (SU) biomanufacturing systems. The reality is that stainless steel and SU can coexist — and often do — in today’s hybrid bioprocessing manufacturing environments.

Downstream Process Development For Efficient Purification Of Adenovirus
Application Note | GE Healthcare Life Sciences

Here, we describe the development of two effective downstream processes for purification of adenovirus from cell culture harvest.

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