Newsletter | January 12, 2023

01.12.23 -- FDA Accepts Stelara Biosimilar BLA For Review

Featured Editorial
Industry Insights
Three Reasons Integrated CDMO Models Are Best

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

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
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

Learn product characterization strategies to de-risk manufacturing and detect and characterize host cell proteins and polyethylenimine in mAb and cell and gene therapies .

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