Drug Development

Articles

The study in 48 healthy adults will assess the safety and immunogenicity of a prime-boost regime of two different intranasal doses of the RSV vaccine, SynGem.

Mucosis Starts Phase I Trial of Needle-Free Nasal-Spray RSV Vaccine

The new facility will focus on formulation development, drug product analytical development, and quality control.

Lonza Holds Grand Opening of New Drug Product Services Labs

German biotech ARTES and Iranian biopharma manufacturer BioSun will develop an HPV vaccine.

ARTES and BioSun Collaborate on HPV Vaccine

David W. Osborne, PhD, is Chief Scientific Officer and Founder, Independent Derm Solutions, LLC, 4215 Creekside Court, Fort Collins, CO 80525.

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.

Impact of Quality by Design on Topical Product Excipient Suppliers, Part II: Reasonable Expectations

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Reliable, high-quality products require innovative analytics and production.

Biosimilars to Drive Modern Manufacturing Approaches

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

A dissolution method should have adequate discriminatory power to detect formulation changes that affect the dissolution rate of a drug product.

Dissolution Testing

A variety of strategies have been employed to deliver proteins and peptides in improved parenteral formulations and/or via noninvasive routes.

Advances in Delivering Protein and Peptide Therapeutics

Astellas will acquire Ganymed and its portfolio of ideal monoclonal antibody candidates.

Astellas to Acquire Ganymed

The biosimilar pathway permits licensure based on less than full clinical data.

FDA Advises Limited Clinical Testing for Biosimilars

Oxford Genetics has secured a GBP1 million capital from investment group Mercia Technologies to support its growth strategy in delivering new services for cancer-fighting gene-therapy technologies.

Formulation and Drug Delivery