Drug Development

David Schoneker is president, Black Diamond Regulatory Consulting, LLC

Videos

In part 2 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, explains what drives the need for the development of a new excipient and how involved regulators are in the process.

Regulatory Involvement in Excipient Development

In part 1 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, explains the difference between a new excipient and a novel excipient and what goes into developing a new excipient.

New Excipient Development–Part 1

Articles

The new facility offers cleanroom packaging and high-sensitivity analytical testing.

BASF Opens GMP Manufacturing Facility in Michigan

Pharmaceutical Technology Europe sat down with Joan Bassa, Human Health Business Unit Director at Bioiberica, to talk about the history of heparin, its uses in pharmaceuticals, and what heparinoids have to offer the industry. 

CPHI Milan 2024: Heparin and Heparinoids in Pharmaceuticals

Pharmaceutical Technology® Europe sat down with Álvaro Nocete Díaz, Pharma Division Manager at HTBA, about the benefits of flavonoids and their use in the pharmaceutical industry. 

CPHI Milan 2024: Flavonoids in Pharmaceuticals

 is Industry Market Manager Biopharma, Pharma EMEA - Brenntag GmbH.

Biopharmaceutical production faces the challenge of ensuring the quality of raw materials due to a lack of specific guidelines. By implementing effective risk assessment strategies and working with reliable, selected solution providers, biopharmaceutical manufacturers can minimize these challenges and improve product quality.

The Quest for Quality: Challenges and Strategies in Raw Material Selection for Biopharmaceuticals

Colorcon provides customers with Opadry complete film coating systems, which intends to help reduce complexity with delivering high-quality products and ingredients.

Colorcon Launches New Titanium Dioxide Free Moisture Protection Coating for Pharmaceutical Tablets

Recipharm will provide analytical and process development capabilities to support toxicology studies, in addition to GLP manufacturing of lipid nanoparticles to capture the active pharmaceutical ingredient, an antigen peptide. 

Recipharm Partners with Ahead Therapeutics to Develop Rare Autoimmune Disease Therapy 

The collaboration partner for Willow is focused on more sustainable methods to manufacture intermediates and APIs at reduced cost and less waste, in addition to looking for Willow’s expertise in developing and scaling key ingredients. 

Willow Biosciences Announces Collaboration with Biopharma Company 

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

The biggest hurdle is developing palatable formulations that are efficacious and patient friendly. 


Ingredients