Drug Development

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

Articles

FDA is encouraging alternative insulins and challenging anticompetitive practices.

Biosimilars Poised for Gains in US Market

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.

Can Vaccine Development Be Safely Accelerated?

Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes.

Alternative Cleaning Validation Methods for Biologics

R. Christian Moreton, PhD, is vice-president of pharmaceutical sciences at Finnbrit Consulting and a member of Pharmaceutical Technology’s editorial advisory board.

Priscilla Zawislak is global regulatory affairs advocacy manager, DuPont Nutrition & Biosciences

Katherine L. Ulman is principal, KLU Consulting

Luke Grocholl is regulatory affairs expertâpharma food materials, MilliporeSigma

With ingredients sold to multiple markets, excipient manufacturers must understand the different regulatory requirements for pharma vs. food.

Comparison of Pharmaceutical Excipients and Food Ingredient Requirements

N4 Pharma will be undertaking a proof-of-concept research project using a COVID-19 DNA plasmid to demonstrate the ability of its delivery system, Nuvec, to collaborative partners developing DNA or RNA vaccines.

N4 Pharma Undertakes Research Project Using a COVID-19 DNA Plasmid

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Considering the potential interaction of a drug with the delivery device early on in in development is integral to achieving the best combination.

Avoiding Negative Drug–Device Interactions

The new molecules entering the development pipeline are bringing forth exciting challenges in drug delivery.

Delivering the Goods

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

But are innovations sufficient to increase adoption? CMOs are demanding better continuous bioprocessing options.

Biomanufacturing: Demand for Continuous Bioprocessing Increasing

With new tests showing NDMA levels increase under normal storage conditions, FDA calls for removal of ranitidine products from the market.

FDA Removes Ranitidine Products from Market

Understanding formulation properties early in development can prevent some costly issues later on.


Formulation and Drug Delivery