Newsletter | January 5, 2023

01.05.23 -- Where Do We Stand On Adopting Continuous Manufacturing For Biologics?
 
Featured Editorial
Rising Interest Rates Skew Risk-Return Paradigm For Life Sciences
 
By Jody Staggs, interim CEO and president, SWK Holdings

Rising interest rates, imploding cryptocurrencies, and erratic equities markets have upended assumptions about risk and returns during 2022. The “risk-free” rate has surged to more than 4% as of late November. Your pharma, biotech, or medical device company looking to raise cash needs to take the key considerations shared in this article into account.
Where Do We Stand On Adopting Continuous Manufacturing For Biologics?
 
By R. Chen, C. Hwang, K. Lee, A. Zydney, and J. Kokai-Kun

Continuous manufacturing offers productivity and cost-saving benefits, among other things, but technical and regulatory challenges have slowed uptake. Speeding up adoption will require innovation and knowledge sharing within the industry and regulatory support from the FDA.
Industry Insights
Comparing Vial Container Closure Systems Using The DeltaCube Modeling Platform
Article | By Anthony Bucci, Ph.D., West Pharmaceutical Services, Inc.

Examine a case study where two 20mm vial CCSs were compared using the DeltaCube Modeling Platform and experimentally show the link between prediction and real performance.
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.
3 Tips For Purifying His-Tagged Proteins
Article | By Emma Lind, Cytiva

Tags simplify purification and enable scientists to use standard protocols while also improving the yield, purity, and solubility of the protein of interest.
How Collaboration Transformed A Generic Into A Best-In-Class New Drug
Case Study | By Andrea Franks, Pfizer CentreOne

Learn how a drug developer collaborated to transform a generic solid active pharmaceutical ingredient (API) into a commercial sterile injectable approved by regulators.
Viral Safety Of Biologics: What's Changing With The ICH Q5A Revision?
Webinar | MilliporeSigma Biosafety Testing Services

ICH Q5A is currently being revised to address recent scientific advancements. We'll discuss the expected changes and potential impact on viral safety strategies.
News Headlines
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