Quality & Compliance

Manufacture Quality & Compliance

The AMR Certificate

02/07/2024 | Jamie Irvine | 5 min read

Introducing the British Standards Institution’s new environmental initiative to minimize antimicrobial resistance caused by manufacturing operations.

Manufacture Quality & Compliance

The Quest for the Golden Batch

01/03/2024 | Eoghan Moloney | 4 min read

Data is power when it comes to batch-quality prediction and obtaining the coveted perfect profile.

Manufacture Technology and Equipment

The Innovation Awards 2023

12/11/2023 | 13 min read

It’s December – time for The Medicine Maker to welcome you to 2023’s most innovative new technologies in drug development and manufacturing

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.

Upcoming Webinar

Manufacture Advanced Medicine

Overcoming Cell Therapy Production Challenges: Maximizing Quality Assurance Through Rapid Sterility Testing

05/16/2024, 11:00 AM US/Eastern | Sponsored by Thermo Fisher Scientific

Join us as we discuss how the SteriSEQ can help uncover potential contamination, thereby mitigating the risk of product loss, production delays, and maintaining the integrity of the final product.

All Webinars