Articles by Jill Wechsler - BioPharm International

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Articles by Jill Wechsler

Manufacturing Issues Crucial to Combating Ebola

Nov 20, 2014

The United States government is ramping up support for formulation, production, and packaging of Ebola treatments.

Combination Products Challenge Biopharma Manufacturers

Nov 5, 2014

Most new injectable drugs and biologics are being designed as combination therapies, presenting difficult regulatory and production issues for manufacturers. FDA policies are encouraging this trend.

New Era for Generic Drugs

Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.
Nov 1, 2014

Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.

Biopharma Manufacturers Respond to Ebola Crisis

Demand for new therapies and vaccines spotlights production challenges.
Oct 1, 2014

Demand for new therapies and vaccines spotlights production challenges.

Data Integrity Key to GMP Compliance

FDA demands accurate manufacturing and test information to ensure product quality.
Sep 1, 2014

FDA demands accurate manufacturing and test information to ensure product quality.

Suppliers Seek to Boost Single-Use Technology

Aug 21, 2014

Attendees at the Bio-Process Systems Alliance annual summit discuss the benefits of single-use technology in biopharmaceutical manufacturing.

Changes and Challenges for Generic Drugs

FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.
Aug 1, 2014

FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.

Industry Seeks Clearer Standards for Track and Trace

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.
Jul 1, 2014

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.

Supplier Audit Program Marks Progress

Jul 1, 2014

Supplier Audit Program Marks Progress

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