Quality & Compliance

Business & Regulation Quality & Compliance

The FDA Investigates T-Cell Malignancies in CAR-T Therapy

12/08/2023 | Jamie Irvine | 4 min read

The details and reactions behind a recent FDA investigation into the cancer-risk of CAR-T therapies

Manufacture Advanced Medicine

Droplet Digital PCR Technology for Accelerated Gene Therapy Testing

12/07/2023 | Sponsored by Bio-Rad Laboratories | 5 min read

Why drug developers are turning to this technique for rapid detection of replication-competent viruses.

Business & Regulation Standards & Regulation

The Ethical Issues of Advanced Medicine

12/04/2023 | Sumukhi Sreevatsan | 3 min read

How do we encourage the development of new cell and gene therapies without compromising our ethics?

Business & Regulation Standards & Regulation

Nowhere to Hide

11/10/2023 | Rob Coker | 2 min read

Never underestimate the meticulousness with which authorities operate or the standards that businesses are expected to adhere to.

Discovery & Development Ingredients

Manufacturers Urged to Take Steps to Avoid DEG and EG Contamination

11/02/2023 | Stephanie Vine | 4 min read

Ongoing issues in the Asian pharma sector prompt an unequivocal response from the FDA and the IPEC Federation.

Discovery & Development Clinical Trials

Ignaz Semmelweis, We Salute You

09/07/2023 | Rob Coker | 4 min read

In the second episode of the We Salute You series, we focus on much maligned Hungarian physician Ignaz Semmelweis

Manufacture Small Molecules

The Contaminated Childrens’ Cough Syrup Scandal

08/18/2023 | Stephanie Vine | 4 min read

I explore recent cases of pediatric cough medicines contaminated with diethylene glycol.

Manufacture Quality & Compliance

Shouldn’t We Modernize Quality Control Operations?

07/13/2023 | Jason Boyd | 4 min read

Three steps to drive meaningful change in quality control.

Manufacture Quality & Compliance

The Only Constant Is Change

06/28/2023 | Stephanie Harden | 5 min read

The Greek philosopher Heraclitus would have (most likely) agreed that QC and QA labs must be prepared for changes.

Manufacture Quality & Compliance

The Automated QC Lab of the Future

06/20/2023 | Mike Wilson

How quality control is getting smarter – but why it needs to be smarter still

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