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Standards & Regulation

Business & Regulation Standards & Regulation

Unproven Stem Cell Ruling Creates Uncertainty

| Stephanie Vine | 2 min read

ISCT speaks out after US court rules that stem cell therapy does not fall under FDA jurisdiction.
Business & Regulation Business Practice

Legislating Meaningful Change

| Maryam Mahdi | 5 min read

Roche’s Kowid Ho talks us through a career spent shaping regulation and striving for pharmaceutical excellence.
Business & Regulation Business Practice

When Two Worlds Collide

| Robin Ellis, Pete Sadler | 5 min read

To see continued progress, the pharma and tech industries must collaborate.
Manufacture Contract Manufacturing Services

Considering Capsids

| Sponsored by Charles River | 5 min read

Determining full versus empty capsids remains a key challenge with adeno-associated viral vectors.

Business & Regulation Business Practice

Rights, Denied

| Maryam Mahdi | 4 min read

How will bureaucratic red tape affect pharma’ ability to support women seeking abortions?

Business & Regulation Business Practice

Patents: Why Pharma & the High Tech Sector Should Collaborate

| Joerg Thomaier | 6 min read

Why pharma and the high tech sector should band together for the sake of innovation.
Manufacture Packaging

Getting to Grips with the E&L Threshold

| Stephanie Vine | 8 min read

The PQRI has released new recommendations on E&Ls in parenterals.
Manufacture Bioprocessing - Upstream & Downstream

Optimizing Manufacturing Strategies for mAbs

| Sponsored by Thermo Fisher Scientific

Making the right decisions in monoclonal antibody production
Manufacture Contract Manufacturing Services

Adversity, Adaption, Delivery, Expansion

| Sponsored by PCI | 8 min read

How one CDMO navigated the pandemic and came out on top of industry trends
Business & Regulation Standards & Regulation

Acting on the Drug Supply Chain Security Act

| Shabbir Imber Safdar | 8 min read

The US drug supply chain is not immune to counterfeits – but there’s a law for that. Here’s how it has been used so far.
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April Issue of The Medicine Maker