Industry Insights
Importance Of Chain Of Custody Documentation For Biologics
Article | Thermo Fisher Scientific

Preventing patients from receiving “counterfeit, diverted, sub-potent, substandard, adulterated, misbranded, or expired drugs” is a critical element of the mission of the US Food and Drug Administration (FDA). Chain of custody for genetic and cell therapies differs and is more complex than for traditional pharmaceuticals, and the requirements for documentation vary as well.

Process Effects On Drug Product Quality In Pharmaceutical Manufacturing — A Validated Measurement Process
White Paper | GE Healthcare Life Sciences

This white paper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.

A Model System For Fast Screening Of Optimal Protein Purification Conditions
Application Note | Bio-Rad Laboratories, Inc.

This study in an overview of a model system for screening optimal protein purification conditions on a mixed-mode cation exchange resin using a statistical software–generated design of experiment (DOE) model with ChromLab Software’s Multivariable Scouting (MVS) function on the NGC Chromatography System.

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