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Quality & Compliance

Manufacture Packaging

Chill Out: Understanding the Realities of mRNA Therapeutic Storage

| Silvia Gallina, Marco Povolo | 4 min read

As we transition into the endemic phase of the pandemic, companies will have to consider how their mRNA products will be housed and stored.

Business & Regulation Standards & Regulation

How to Avoid FDA Warning Letters

| Stephanie Vine | 3 min read

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

Business & Regulation COVID-19

VIDEO: From Quality Control to Cold Chain

| Sponsored by Dätwyler

The world wasn’t ready for COVID-19. But if we learn the right lessons, next time next time we’ll do better.

Manufacture Facilities

Don’t Worry, Be HPAPI

| Angus Stewart

We dig into the story of Lonza in China, and its new HPAPI expansion in Guangzhou

Discovery & Development Analytical Science

Meet the Trendsetting Techniques of Biotherapeutic Molecule Characterization

| Eliza Lee

Advanced analytical technologies now offer the detailed assessments biopharma drug developers need.

Business & Regulation Standards & Regulation

Sharing is Caring (for Animals)

| Stephanie Vine

How an initiative from EFPIA and a new public database on chemical substances could reduce animal experiments.

Manufacture Facilities

Embracing the Quality Mindset

| Mike Martin

With the FDA still behind on inspections, manufacturers need to uncover their own blindspots.

Business & Regulation Standards & Regulation

The (DILI) Model of Success

| Maryam Mahdi

An industry consortium is tackling one of pharma’s biggest drug-related challenges.

Manufacture Analytical Science

Understanding Bad Behavior

| Stephanie Vine

Researchers explain how they used video games to explore human behavior when it comes to producing pharma products.

Manufacture Facilities

Adapt or Get Annexed?

| Christian Dunne

Changes are coming to Annex 1 of the EU’s GMP. What can pharma expect?

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