Newsletter | May 6, 2019

05.06.19 -- Toward A More Robust Regenerative Medicine Regulatory Pathway

Featured Editorial
Toward A More Robust Regenerative Medicine Regulatory Pathway
By Randy Hubbell, president and CEO, Carmell Therapeutics

In recent months, the FDA has increased its compliance focus on the regenerative medicine industry, vowing to crack down on illicit stem cell clinics and others advertising the untested use of human cell and tissue-based products (HCT/P), many of which are used in orthopedics.

An Introduction To Adverse Event Reporting And Product Complaints For Pharma Companies
By Joy McElroy

Managing complaints and controlling adverse events are critical processes for a pharmaceutical company. While varying international regulations for adverse event reporting and product complaint handling make it difficult to automate processes and implement SOPs, it is necessary for companies to successfully resolve incidents and continue on a path to innovation.

Industry Insights
How To Transfer Cell-Based Potency Assays Into A GMP Environment And Maintain Performance
Article | By Aryo Nikopour and Ming Li, Ph.D., Nitto Avecia Pharma Services

Cell-based potency assays don’t travel well. Here’s how to make their trip more pleasant from a non-GMP lab to a GMP environment.

Bispecific Antibody Purification: Insights And Case Studies
Article | By David Westman, GE Healthcare Life Sciences

New modalities, such as bispecific antibodies, present unique challenges compared to monoclonal antibody (mAb) production. For purification, there’s not just one right answer to which strategy to use. Here are some industry insights to help you navigate the bispecific jungle.

Process Analytical Technology (PAT) For Continuous Bioprocessing
Poster | By Edita Botonjic-Sehic and Steven Harris, Pall Biotech

The adoption of innovative technologies to perform timely measurements on critical quality attributes (CQAs) of raw and in-process materials allows better process understanding and control.

Implications Of Inaccurate Forecasting On Biologics Manufacturing
Article | Thermo Fisher Scientific

Inaccurate demand forecasts can have significant implications for companies developing biologics. Furthermore, it is increasingly difficult to locate capacity to respond to demand changes.

Looking Under The Hood Of The Unified Lab
Webinar | Dassault Systemes Americas

Striving to bring the way we acquire, share, and gain insights from scientific data through a community and into a framework for standardization and linked data.

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