Newsletter | January 12, 2023

01.12.23 -- FDA Accepts Stelara Biosimilar BLA For Review
 
Featured Editorial
CDMO Partnerships In Early Development Aren’t Always The Best Choice
 
By Aisha Shakeel and Kieran Reals, PA Consulting

This article looks at the needs and challenges biotech organizations face during the manufacture of therapies, how they can reduce costs, and how establishing — or not establishing — partnerships with CDMOs can help get their therapies to patients faster.
ICH Issues Draft Guideline On Viral Safety Evaluation Of Biotech Products
 
By Tim Sandle, Ph.D.

Viral contamination can affect raw materials, cell culture processes, bioreactor contamination, and downstream processing. ICH's new draft guideline titled Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin is available for public comment through the FDA (ending January 14, 2023) and through the EMA (ending February 10, 2023).
Industry Insights
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.
Dry-Powdered Medium Milling Equivalency Study
Article | Cytiva

An assessment of the physical, chemical, and biological characteristics of representative complex media and feeds was made to compare pin mills and overall dry-powdered medium manufacturing processes.
Impact Of PFS Needle Dimensions On High-Volume, High-Viscosity Fluid Delivery
Poster | By Christopher J. Rini, Rick Klug, Aishwarya Vaidyanathan, Bruce Roberts, Didier R. Morel, Ph.D., Ronald J. Pettis, Ph.D., BD Medical - Pharmaceutical Systems
High-volume parenteral delivery systems require consideration of both functional design and human factors to enable successful and consistent reliable delivery to the target tissue. Examine the influence of needle inner diameter and length on delivery time across a range of fluid viscosities using a prototype auto-injector device.
Process Impurities: Don’t Let PEI Or HCP Derail Your Biotherapy
Webinar | MilliporeSigma Biosafety Testing Services

Learn product characterization strategies to de-risk manufacturing and detect and characterize host cell proteins and polyethylenimine in mAb and cell and gene therapies .
News Headlines
Solutions
Sterile Injectables Made With Intelligent Collaboration
Pfizer CentreOne
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