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Quality & Compliance

Manufacture Quality & Compliance

The AMR Certificate

| 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

| 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

| 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

| 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

| 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

| 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

| 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

| 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

| 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

| Stephanie Vine | 4 min read

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


Latest White Papers

Overcoming the challenges of nitrosamine impurities in drugs

| Contributed by Thermo Fisher Scientific

HRAM LC-MS method for the determination of nitrosamine impurities in drugs

| Contributed by Thermo Fisher Scientific

LC-MS/MS method for the quantification of 10 nitrosamine impurities in metformin

| Contributed by Thermo Fisher Scientific

All White Papers

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