Newsletter | April 21, 2022

04.21.22 -- Amneal Achieves Second U.S. Biosimilar Approval
 
New Podcast Episode
Featured Editorial
FDA Seeks Public Comment On Quality Metrics Reporting Program
 
By Mark Durivage, Quality Systems Compliance LLC

The FDA recently announced it is soliciting comments on changes to its previously proposed Quality Metrics Reporting Program. This article shares which primary metrics the FDA intends to collect data on as well as the FDA's questions for input. The comment period ends June 7, 2022.
Betting The House: CDMO Selection For Emerging Pharma
 
By David Stowe and Greg Anthos, Tunnell Consulting

How an emerging company selects a CDMO to produce materials for clinical trials and commercial production is like the high stakes of betting the house at a pivotal point in a card game. A good gambler knows how to assess the risks and odds to know when it's best to “bet the house.” Selecting the right CDMO can lead to successful clinical trials and rapid commercial growth.
Industry Insights
Top Four Considerations For Tech Transfer Performance
Article | By Lei Zheng, Pfizer CentreOne

Successful tech transfer is how long-term strategic CDMO relationships begin. A product’s continued success may hinge on this critical exchange of product data and required regulatory filings.
Gliding Toward De-Risked Combination Product Development
Article | By Victoria Meyer, BD Medical - Pharmaceutical Systems

Discover how a new product’s role is critical in determining combination products’ exposure to extractables and leachables.
Guide Clients Through Drug Development With Intelligent Collaboration
Q&A | Pfizer CentreOne

This article recounts a recent discussion with the general manager of Pfizer CentreOne, regarding what it’s like to lead an embedded CDMO within one of the largest pharmaceutical companies.
How Buffer pH And NaCl Affect Size Exclusion Chromatography
White Paper | Cytiva

Using a design of experiments approach, this study describes the effect of buffer pH and NaCl concentration on proteins purified by size exclusion chromatography.
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