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Quality & Compliance

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?

Manufacture Advanced Medicine

The ABCs of Apheresis Infrastructure

| Lacey Anderson

Building and managing an advanced therapy collection network is a significant challenge, but there is another route.

Manufacture Biosimilars

Driving Down Biosimilar COGS

| Amanda Turner, Khaled Mriziq

To keep biosimilars costs as low as possible, take a good look at your purification and characterization processes.

Manufacture Quality & Compliance

Always Watching

| Paul Daniel

Simple and efficient systems for continuous monitoring can make all the difference in developing innovative products.

Business & Regulation Standards & Regulation

Of Medicine and Machine Learning

| Angus Stewart, Stephanie Vine

AI is expanding into medicine. Are the world’s regulators ready?

Manufacture Technology and Equipment

Now You See It

| Andrea Sardella

What are the challenges and best practices in quality control for difficult-to-inspect products?

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