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Manufacture

Manufacture Standards & Regulation

Safety First - Sizing Up Biologics Side Effects

| Catherine Akers

Biologic medicines present unique challenges for pharmacovigilance. And with biosimilars hitting the market, life just got more complicated.

Manufacture Bioprocessing - Upstream & Downstream

Pass Me a Bottle Opener

| Jaime Marach

Can a new generation of chromatography techniques and technologies get things moving again?

Manufacture Small Molecules

Calculate – Don’t Estimate – Drug Development Costs

| Ayman Chit

Researchers estimate the cost of drug development at over $1 billion, while others say it’s less than $100 million. Who’s right?

Manufacture Biosimilars

The Monoclonal Milestone

| Carsten Brockmeyer

The launch of the world’s first biosimilar monoclonal antibody was a big step forward from a regulatory and scientific standpoint.

Manufacture Small Molecules

The Final Frontier?

| Stephanie Vine

The Galactic Grant Competition encourages companies to use the International Space Station for pharmaceutical R&D

Manufacture Technology and Equipment

Game On

A business simulation video game called Big Pharma is being made by a UK game studio called Twice Circled.

Manufacture Facilities

Terminal Inertia

| Jeanne Moldenhauer

It is clear that terminal sterilization is the gold standard for sterile drug manufacture, so why are companies so reluctant to pursue it?

Manufacture Advanced Medicine

Don’t Forget CDx Developers

| Mark J. Roberts

Many drug developers are going ‘full steam ahead’ with personalized medicine strategies.

Manufacture Small Molecules

Antibiotic Apocalypse: Part II

| Stephanie Vine

The rise of drug resistance has left us facing a future with few effective antibiotics. Do the next-generation antibiotics in the pipeline offer hope?

Manufacture Biosimilars

Singular Head of Generics

| Charlotte Barker

Sitting Down With… Nick Haggar, Head of Western Europe, Middle East & Africa, Sandoz, and President of the European Generic Medicines Association (EGA).

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