Formulation and Drug Delivery

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FDA Releases Draft Guidance on Biosimilarity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Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.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.

Packaging Becomes Enabler for Biopharmaceuticals

May 02, 2014

PTSM: Pharmaceutical Technology Sourcing and Management

Once an afterthought, packaging has now become an essential component of biopharmaceutical product development and marketing.

Achieving Zero-Order Release Kinetics Using Multi-Step Diffusion-Based Drug Delivery

May 02, 2014

Zero-order release of a freely water-soluble active drug can be obtained using release-controlling polymers.

Boosting New Antibiotic Drug Development in Europe

May 02, 2014

With the rising threat of antibiotic resistance and a diminishing R&D pipeline for novel drugs, Europe must step up its game to address this growing problem.