Newsletter | December 15, 2022

12.15.22 -- ACMA Develops Board-Certified Biologics & Biosimilars Specialist Certification
 
Featured Editorial
A Methodology To Support Particle Investigations In Biopharma Products
 
By BioPhorum

Particles in parenteral products are a major cause of product recalls, and appropriate management of risk from visible particles is vital. This standardized methodology provides users with a decision-making tool to clarify the risks presented by a particle to a batch.
Create The Correct Checklist To Land The Best CDMO
 
By Stephanie Gaulding, managing director, Pharmatech Associates

When considering outsourcing strategies, develop the right kind of checklist that considers human dynamics. This is not a script, nor is it static. Flexible enough to meet the needs of the project and the personnel, this spec will help you create frameworks, master service agreements, and quality agreements for the best oversight of your supplier.
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.
Tips For Purifying Cryo-EM Samples
Webinar | By Kristin Lenberg, Cytiva

Cryo electron microscopy can help you determine structures for challenging proteins such as membrane proteins and larger complexes. This presentation offers tips on purifying your cryo-EM samples.
Three Reasons Integrated CDMO Models Are Best
Article | Pfizer CentreOne

Some of pharma’s top brands developed their own responses to the demand for strategic outsourcing, creating a distinct class of contract development and manufacturing services suppliers.
Guide Clients Through Drug Development With Intelligent Collaboration
Q&A | Pfizer CentreOne

This article summarizes 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.
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