Drug Development

Andrew Harrison is chief regulatory affairs officer and general counsel with Regulatory Compliance Associates.

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Articles

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss performing investigations of biological products.

Investigating Biologics

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

The development of successful ADCs involves careful selection of drug, antibody, and linker, as well as choosing the right attachment chemistry to link the cytotoxic to the antibody.

Building Safe and Effective Antibody-Drug Conjugates

This article looks at the current status of alcohol-induced dose dumping of modified-release formulations and the need for regulatory harmonization in handling this challenge.

Regulatory Considerations for Alcohol-Induced Dose Dumping of Oral Modified-Release Formulations

New formulations that enhance bioavailability, optimize drug-delivery profiles, reduce dosing frequency, or improve patient experience have the potential to deliver quicker returns on investments than developing a completely new drug.

Stretching Product Value  through Reformulation Strategies

Ananda Seneviratne is principal scientist, Analytical and Formulation Development at Agensys, Inc., Santa Monica, CA.

Gaya Ratnaswamy is director, Analytical and Formulation Development at Agensys, Inc., Santa Monica, CA.

Characterization and Formulation Screening of mAb and ADCs by  High-Throughput DLS

Hovione will double its manufacturing capacity in New Jersey with an expanded facility and a commercial spray dryer designed to handle potent APIs.

Hovione Expands Drug Substance Manufacturing

The CDMO is striving to become a market leader in the development and manufacturing of antibody-drug conjugates.

Piramal Introduces Proof of Concept Service for Next Wave of ADC Growth

The agency releases guidance on controlled correspondences related to generic-drug development.

FDA Releases Guidance on Generic-Drug Development

There is growing interest in the development of liquid formulations in prefilled syringes and autoinjectors, which offer convenience and ease of administration in a home setting.

Trends in Biologics Drug Delivery

Cobra Biologics and the University of Manchester announce a collaboration to improve industrial scale-up of mammalian cell bioprocessing.

Formulation and Drug Delivery