Newsletter | April 25, 2024

04.25.24 -- Digitizing CMC Knowledge Management

SPONSOR

Webinar: Addressing The Options And Challenges In Subvisible Particulate Contamination Monitoring In Single Use

Join us for a webinar on May 16th with Entegris! Particulate contamination in pharmaceutical and biopharmaceutical products produced using single-use systems can create detrimental health risks that are required to be minimized by regulatory agencies. This contamination can be divided into visible and subvisible ranges, both ranges of particles are tested using different techniques. 

Click here to learn more.

FOCUS ON REGULATORY

Digitizing CMC Knowledge Management

By Irwin Hirsh, Q-Specialists AB

Systems that enhance know-how retention stretch from utterly simple to enterprise-scale. Here are some ideas for incorporating them into your knowledge management strategy.

Preparing For FDA Pre-Approval Inspection: Quality And Regulatory Topics

Webinar | Lonza

Learn about strategies to meet the quality and regulatory requirements of cell and gene therapies and how to identify issues early on, reduce quality and compliance risks, and avoid delays and rework.

NEW PODCAST EPISODE

Physician + Biotech Builder with Tome Biosciences' Rahul Kakkar, M.D.

Novel technologies aren’t interesting to Rahul Kakkar, M.D. unless they help patients. Sounds rational, but it’s a unique perspective in a platform-crazed biotech industry. Dr. Kakkar’s worldview is shaped by his work as a physician — work he continues even as he builds Tome Biosciences, where he serves as President & CEO. On Business of Biotech, Dr. Kakkar shares how his work as a physician informs his leadership, biopharma’s bad rap, and a whole lot more.

FOCUS ON ANALYTICS & QUALITY

Eying Up The Era Of Topical Biologics

By Matthew Pillar, Editor, Bioprocess Online

Claris Bio’s phase 1/2 clinical trial in patients with Stage 2 or 3 Neurotrophic Keratitis is breaking new ground in the development of topical biologic therapies. 

Reflecting Again On GMP Requirements For Marketing Authorization Holder

Article | By Geraldine Carr-Mulry, CAI

Learn in detail about Annex 16, the responsibilities of marketing authorization holders (MAHs), and a practical way for MAHs to implement their responsibilities with their contract manufacturers.

Data-Driven Approach Optimizes Robust, Scalable Lyophilization Process

Article | By Jeff Tremain, AbbVie

Selecting the right manufacturing partner with appropriate lyophilization expertise, experience, and analytical capabilities can speed drug development and expedite time to market for lyophilized drugs.

A Novel Thermodynamic Assay For Biomolecular Structure Stability

Application Note | TA Instruments

This comparability study utilized a nano differential scanning calorimeter to detect biomolecular structure changes in response to subtle manipulations of liquid protein reference formulation.

The 6 Must Haves Of Bioprocess Software

Article | INFORS HT

Utilizing modern technologies to create bioprocess software and discover scalable solutions that meet your existing and future data needs for bioprocessing.

ANALYTICS & QUALITY SOLUTIONS

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Industrial Data Operations Software Solution For Life Sciences - HighByte

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