Formulation and Drug Delivery

Oral Delivery of Biologic APIs: The Challenge Continues

March 02, 2017

Effective solutions for overcoming the high molecular weight, hydrophilicity, and instability of large biomolecules have yet to be identified.

Operational Excellence at Baxter BioPharma Solutions

March 02, 2017

Pharmaceutical Technology spoke with Frank Generotzky, plant manager for Baxter BioPharma Solutions’ Halle, Germany facility, about operational excellence at the site.

An Investigation of the Anomeric Stability of Lactose Powder Stored Under High Stress Conditions

March 02, 2017

This study investigated the stability of solid lactose stored under high temperature and humidity conditions.

Overcoming the Challenges of Capsule Filling in Preclinical and Clinical Studies

March 02, 2017

The authors discuss the challenges of capsule filling in preclinical and clinical studies.

Key Considerations in Capsule Filling

March 02, 2017

Capsule filling is a complex process, and the product to be encapsulated must be well developed to ensure mass uniformity.

UKSCB Releases Stem Cell Lines for Development

March 01, 2017

The UK Stem Cell Bank released validated stem-cell lines for researchers developing novel cell-based therapies for clinical trials.

Sanofi and Lonza Partner on mAb Cell Culture Facility in Switzerland

February 27, 2017

Sanofi and Lonza formed a joint venture to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland.

FDA’s Office of Generic Drugs Releases Annual Report

February 24, 2017

In 2016, FDA approved 630 ANDAs and tentatively approved 183 ANDAs, the highest number to date, according to the report.

Can Bigger be Better?

February 23, 2017

The industry is becoming more consolidated, but there needs to be some strategy behind the mergers and acquisitions.

Combination Products: Regulatory and Patent Issues You Should Consider Now

February 23, 2017

The authors discuss regulatory and patent issues with combination products.