Newsletter | March 20, 2023

03.20.23 -- Women Rising In Cell & Gene Therapy
 
Sponsor
From The Editor
Women Rising In Biotech
 
By Louis Garguilo, chief editor, Outsourced Pharma

Recent studies show women in the pharma industry represent 61% of the workforce, considerably higher than other industries. However, the percentage of female leaders is significantly lower. I spoke to an up-and-coming cell and gene therapy professional about this.
Featured Editorial
ICH Guideline Q9(R1) On QRM, Part 1: Formality And Risk-Based Decisions
By Stacey Largent and Virginia Andreotti-Jones, ValSource Inc.

The long-awaited revision to ICH’s harmonized tripartite guidance on quality risk management (QRM), Q9(R1), was adopted on January 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.
Industry Insights
5 Reasons Why You Need To Review Your Data Privacy Policy Now
Article | By Neil Jones, Egnyte

Data privacy will be a much bigger focus for small and midsize businesses in 2023, as stricter privacy legislation is enacted. Learn key reasons to review your privacy policy.
Using Mathematical Models To Improve Process Development
Article | Cytiva

Mathematical models are recommended to generate enhanced process understanding and meet QbD guidelines. Explore the differences between statistical and mechanistic models along with their use in improving process development.
Liposomal And Nanoparticle Technology
White Paper | Pfizer CentreOne

Specializing in oncology, anti-infective, and complex formulations, this facility provides end-to-end services from development through to commercial manufacture of sterile dosage forms.
How To Automate Continued Process Verification
e-book | MilliporeSigma

This e-book describes automation of continued process verification and offers a one-click solution for statistical trending of data, campaign reports, and annual product quality reviews.
Critical Quality Attributes Of Plasmid DNA For Advanced Therapies
Infographic | Thermo Fisher Scientific

Review helpful insights on critical quality attributes impacting plasmid DNA.
Future-Proof Your Aseptic Filling
Webinar | Resilience US, Inc.

Using the Cytiva SA25 Aseptic Filling Workcell, a standardized system designed with flexibility built in, ensures that companies can pivot between products quickly and adapt as manufacturing needs change.
Solutions
Nonproprietary Assays: Advancing Your Molecule With Speed
Pyxant Labs
Your Guide To General Toxicology
Charles River
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