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Standards & Regulation

Manufacture Packaging

Getting to Grips with the E&L Threshold

| Stephanie Sutton | 8 min read

The PQRI has released new recommendations on E&Ls in parenterals.

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

Manufacture Bioprocessing - Upstream & Downstream

Optimizing Manufacturing Strategies for mAbs

| Sponsored by Thermo Fisher Scientific

Making the right decisions in monoclonal antibody production

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.

Business & Regulation Standards & Regulation

How to Avoid FDA Warning Letters

| Stephanie Sutton | 3 min read

It’s relatively simple: Follow cGMP, keep your facilities clean, keep vermin out, and don’t sell unapproved products…

Business & Regulation Trends & Forecasts

Chasing Harmony

| Angus Stewart | 8 min read

An inside view of the pharmaceutical industry in China. Where has it been, where does it stand, and where is it going?

Business & Regulation COVID-19

From COVID-19 to Monkeypox

| Stephanie Sutton

It’s been a busy time for infectious disease vaccine news in Europe.

Business & Regulation Standards & Regulation

Quick-Fire Q&A: Biosimilars in the US

| Stephanie Sutton | 3 min read

Biosimilars have been available in Europe for years. Is the US still lagging behind?

Manufacture Biosimilars

Towards Better Biosimilar Access

| Maryam Mahdi | 4 min read

Though in theory, biosimilars should help improve medicines access, what challenges still stand in the way of therapeutic equality and equity?

Business & Regulation Business Practice

Moderna Begins New Search for Chief Financial Officer

| Stephanie Sutton

Moderna’s new CFO lasts one day in the job as investigation comes to light.

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