Newsletter | December 9, 2021

12.09.21 -- Why We Should Celebrate This FDA Leadership Shift

 
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Bayer Evaluates Fibro For Scalable Single-Use mAb Purification
Learn how Bayer evaluated Fibro PrismA chromatography to determine its potential as a true single-use monoclonal antibody (mAb) capture technology. They assessed scalability from lab-scale to process-scale tracking pressure drop, step recovery, purity, and eluate volumes across multiple cycles. Read the outcome here.
Technology Transfers: A Beginner’s Guide

You may have questions and knowledge gaps regarding technology transfers. This beginner’s guide covers the basics and the three key phases of technology transfers.

A Look Into The Future Of Bioprocessing

The Internet of Things (IoT) and robotics are now being implemented in the biopharma industry, which is more conservative due to strong regulations and intrinsically complex processes. Industry experts for process analytical technologies, automation, and data analytics share their views on the future of bioprocessing.

Addressing The Evolving Needs Of Variable Drug Delivery Regimens

Pharmaceutical companies now have a wearable solution designed to enable new delivery formats in alternate settings and for customization to support adjustments to existing formulations and variations in treatment regimens.

How To Use QbD Software To Improve An Existing Identification Method

What can you do when the identification method defined by the USP monograph does not provide clear guidance? The authors decided to improve the method with a quality by design (QbD) approach.

CDMO Collaboration: Foundation For Sterile Injectable Product Success

Explore how a small or midsize biotech or pharma company developing sterile injectables can benefit from the experience and assistance provided by a CDMO.

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