Articles by Martin van Trieste - Pharmaceutical Technology

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Articles by Martin van Trieste

Biosimilars Development and Supply: How Complex Can the Process Be?

As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.
Sep 2, 2013

As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.

Achieving More Effective and Efficient GMP Auditing

Adherence to GMP in API manufacturing is crucial in determining the safety of drug products. Due to the limitations of quality-control testing and repeatedly occurring major API adulterations, the regulations for supplier qualification have been globally tightened. As a consequence, authorities demand more vigilance of the pharmaceutical supply chain. API and other starting material manufacturers are facing an ever-increasing demand for on-site audits from their pharmaceutical customers.
Feb 1, 2013

Adherence to GMP in API manufacturing is crucial in determining the safety of drug products.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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