Newsletter | March 13, 2025

03.13.25 -- Emerging Trends In mAbs Manufacturing

FEATURED EDITORIAL

Emerging Trends In mAbs Manufacturing In 2025 And Beyond

By Bikash Chatterjee, CEO, Pharmatech Associates

Two key innovations — continuous perfusion in upstream processing and multicolumn chromatography in downstream processing — are having a profound impact on biologics manufacturing.

Ensuring Repeatable, Viable Surface Sampling In Aseptic Settings

By Josh Erickson, USP

Without high quality data, surface sampling simply becomes another exercise in checking regulatory compliance boxes.

FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products

By Susan Shockey, Clarkston Consulting

The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. The public comment period ends April 7.

INDUSTRY INSIGHTS

The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly

Article | Cytiva

In your pursuit of developing a high-quality biosimilar, think strategically. Consider what type of biologic your team’s expertise can support and which is needed most in your target market.

NEWS HEADLINES

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Celltrion Receives U.S. FDA Approval For STOBOCLO (denosumab-bmwo) & OSENVELT (denosumab-bmwo) Biosimilars Referencing PROLIA & XGEVA

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Fresenius Continues Growth Of Biosimilars Portfolio With The U.S. Availability Of Otulfi (ustekinumab-aauz)

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Amneal's BLA Submissions For 2 Denosumab Biosimilars Accepted For Review By U.S. FDA

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SmithRx Introduces Stelara Biosimilars To Its Autoimmune Program, Helping Clients Save A Projected $14.5M In Prescription Drug Costs