Newsletter | August 3, 2019

08.03.19 -- 3 Steps To Prepare For FDA's Final Quality Metrics Guidance

 
Industry Insights
Addressing New Chromatography Challenges With Fiber Adsorbents
White Paper | By Iwan Roberts, GE Healthcare Life Sciences

A new adsorbent material using a novel proprietary structure overcomes the diffusional and flow limitations of packed bed chromatography purification systems and also aims to address the capacity issues of chromatography membranes.

3 Steps To Prepare For FDA’s Final Quality Metrics Guidance
Article | Dassault Systemes Americas

Reacting to trends, including drug shortages and plant inspections that increasingly question manufacturing data integrity, FDA’s recent draft guidance Request for Quality Metrics promotes a “quality-driven corporate culture” as one of its goals.

A Strategy To Remove Formulation Development From The Critical Path During Biologics Development
Q&A | Catalent

Biopharmaceuticals tend to be highly unstable. A pilot formulation study at the early drug substance development stage can make things considerably easier at the manufacturing stage, according to Yunsong (Frank) Li, director of process development at Catalent Biologics, in this Pharmaceutical Technology interview.

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