Newsletter | July 15, 2019

07.15.19 -- Environmental Isolates: What's The Proper Use Of In-House Cultures?

  The CMC Function: Best Practices And Optimization

ISR interviewed chemistry, manufacturing, and controls (CMC) professionals at 14 Top 50 pharmaceutical and biotechnology companies, and one company outside the Top 50 to better understand the chemistry, manufacturing, and controls function throughout the preclinical, clinical, and commercialization phases of the product development process. This report also details how CMC departments are modeled, the challenges faced by CMC professionals, best practices, and perspectives about how the role may evolve over time. More.

Featured Editorial
Environmental Isolates: What’s The Proper Use Of In-House Cultures?
By Crystal M. Booth, PSC Biotech

Use of environmental isolates in the biopharmaceutical microbiology laboratory has been increasing in popularity, and, in some instances, warning letters have been written for not using environmental isolates in microbiological testing. This article discusses current regulations and guidance, regulatory expectations, and expert opinions.

What To Do When Your CDMO Receives A Warning Letter
By Barbara Berglund, COO, CMC Turnkey Solutions

You have just completed a full technical transfer to a CDMO for your commercial drug product. This has been a two-year program and you are gearing up to launch the opening campaign. Then, the regulatory team from the CDMO alerts you that it has been issued a warning letter by the FDA.

Industry Insights
Closed And Semi-Automated Processing Of CAR T Cells
Application Note | GE Healthcare Life Sciences

T-cell immunotherapy challenges include costly manufacturing, lengthy and complex open workflows, and high manual labor requirements that influence product variability. This application note details a CAR T-cell manufacturing workflow that can be adapted for cGMP compliance in commercial production.

Rapid, Serum-Free, High-Yield Antibody Production In PETG Roller Bottles
Application Note | Thermo Fisher Scientific

A rapid, flexible, and high-yield approach for both hybridoma expansion and for antibody production using a serum-free medium in Nunc PETG Roller Bottles.

Acidic IgM Purification With The Strong Anion Exchanger
Poster | Bio-Rad Laboratories, Inc.

IgM antibodies are one of the fastest growing groups of diagnostic and therapeutic candidates, but, unlike IgGs, IgMs cannot be purified by affinity chromatography due to their physiochemical properties. Their large size presents an additional purification challenge.

  Festival Of Biologics 2019

October 15 to 17, 2019 | Basel, Switzerland

The Festival of Biologics 2019 will address the strategic and commercial aspects of discovering, developing, and bringing new biologics to patients with high-level, global speakers from Big Pharma, biotech, academia, and industry. We will bring you three days packed full of top-level science, data, case studies, workshops, roundtables, and networking opportunities. With 350 speakers and 1,500 attendees, this is an event not to be missed.

Capsule Filters
Meissner Filtration Products
API To Clinic Within 4 Months
Nitto Avecia Pharma Services
Ibex Design
Lonza Pharma & Biotech
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