Quality Systems

Understanding Excipient Characteristics to Ensure Robust Continuous Manufacturing

June 13, 2024

Key information is needed for excipients and their potential impact on continuous manufacturing processes.

Determination of Shelf-Life from Stability Data: From Replicates or from Averages?

June 11, 2024

A statistical analysis for determining an expiration date can be applied to replicates or their corresponding averages as suggested in industry guidelines.

CDER Announces Emerging Drug Safety Technology Meeting Program

June 10, 2024

The new meeting program will create a dialogue around AI and be administered through CDER’s Emerging Drug Safety Technology Program.

Drug Shortage Reports Emphasize Continuing Problems

June 10, 2024

USP and FDA publish reports detailing drug shortage numbers and challenges through 2023.

Diversifying the Supply of Raw Materials

June 08, 2024

The final drug product relies on the quality and reliability of the raw materials used in its production.

The Need for Automated and Standardized CGT Manufacturing (BIO 2024)

June 07, 2024

Lonza’s Joe Garrity and Jerry Jiang discuss the importance of not only automating CGT manufacturing, but also standardizing across processes.

Using RWD in Non-Interventional Studies

June 05, 2024

EMA is promoting the use of RWD in decision-making and has started a public consultation to review its draft recommendations.

CGT Catapult and CATTI Establish Shared Training Standards for Advanced Therapies

June 04, 2024

CGT Catapult and CATTI aim to standardize advanced therapy manufacturing with new aligned training standards.

Rapid Sterility Methods for CAR T-cell Therapies

May 30, 2024

A combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.

Sanofi Gets Priority Review Status for sBLA Seeking Approval of Sarclisa in Combination Therapy for Multiple Myeloma

May 30, 2024

FDA granted priority review to Sanofi's sBLA for Sarclisa in combination with VRd in treating transplant-ineligible patients who are newly diagnosed with multiple myeloma.