Formulation and Drug Delivery

Advances in Controlled-Release Drug Delivery

June 02, 2014

Industry experts share their perspectives on key advances in controlled-release drug delivery and future innovations in this arena.

FDA Issues Guidance on Expedited Programs for Serious Conditions

May 30, 2014

FDA finalizes guidance on expedited programs for new drug approvals for treatment of serious and life-threatening conditions.

GSK Announces Vaccine Price Freeze in Support of GAVI Alliance

May 27, 2014

PTSM: Pharmaceutical Technology Sourcing and Management

GSK reports 5-year vaccine price freeze for countries graduating from GAVI Alliance.

Novasep Commissions Plant Extension for Highly Potent APIs

May 15, 2014

PTSM: Pharmaceutical Technology Sourcing and Management

New manufacturing capacity at the Le Mans, France facility is being used to scale up antibody drug conjugates.

Continuous Bioprocessing Challenges

May 15, 2014

What challenges do biopharmaceutical manufacturers face when deciding to move from a fed batch process to a continuous process?

Determining Cross-Contamination Risks in Multiproduct Biopharmaceutical Facilities

May 15, 2014

A global contract manufacturer of biologics discusses the increasing impact of health-based exposure limits in assessing cross-contamination risks.

Using Modular Systems in Biopharmaceutical Manufacturing

May 15, 2014

What is a modular system and how are modular systems being used in the biopharmaceutical industry? Pär

FDA Releases Draft Guidance on Biosimilarity

May 14, 2014

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

Advanced Aseptic Technology Provides Glass-Free Delivery of Injectable Drugs

May 14, 2014

Equipment and Processing Report

Catalent's Advasept platform uses blow-fill-seal technology to aseptically manufacture, fill, and seal a polymeric primary container for injectable drugs.

Extractables and Leachables Testing

May 02, 2014

Industry experts discuss how extractables and leachables studies are designed using a risk-based approach.