Drug Development

Videos

The importance of characterizing excipients, supply chain security, and the role of novel excipients are explored.

Excipient Quality and Impact on Formulation

Articles

The CGMP manufacturing agreement will expand production of lenzilumab, a candidate for COVID-19 therapy, to support a potential emergency use authorization filing.

Avid Bioservices Enters Manufacturing Agreement with Humanigen for Lenzilumab

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

Plasma-based proteins and cell-based therapies have significant potential to address unmet medical needs.

Exploring the Therapeutic Value of Blood Components

Eric Sanchez is a senior consultant of Integra Continuous Manufacturing Systems with a special focus on the implementation of continuous manufacturing methods. He joined the firm after a successful 31-year career with Janssen Pharmaceuticals.

Fernando J. Muzzio, PhD, is distinguished professor of the School of Engineering at Rutgers, The State University of New Jersey, Piscataway, NJ 08855. Dr. Muzzio is a member of 

 editorial advisory board and President of Integra Continuous Manufacturing Systems.

Advanced manufacturing technologies are available, but challenges need to be addressed.

 Reshoring Pharmaceutical Manufacturing to the US: Can We Do It?

Jennifer Putnam is AR&D supervisor II, Perrigo

Katherine L. Ullman is president, KLU Consulting, LLC

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

David Schoneker is president, Black Diamond Regulatory Consulting, LLC

George Collins is vice president, Vanderbilt Chemicals LLC. 

Douglas G. Muse is consultant—Compendial Affairs, Eli Lilly & Co.

Brian Carlin is director QbD/Regulatory, DFE Pharma US

Joseph Zeleznik is technical product director, IMCD US

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

Viewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.


Understanding Concomitant Components in Pharmaceutical Excipients

Feliza Mirasol is the science editor for 

Open communication and transparency coupled with technical expertise foster strong long-term manufacturing partnerships.

Selecting the Right-Fit Partner for Biotherapeutic Development

The collaboration will focus on up to three types of lung and gastrointestinal cancers.

Boehringer Ingelheim and Enara Bio Partner on Cancer Immunotherapies

Using rDNA technology to synthesize production of proteins and peptide hormones, the biotech startup has achieved synthetic production of insulin, potentially lowering insulin cost by 30%. 

rBIO Hits Key Lab Milestone with Synthetic Production of Insulin

A newly developed polymer, DynaShield, may have the capability to ensure global access for COVID-19 treatment and prevention.

Helena Offers Polymer Solution to Global Cold Chain Issues for COVID-19 Vaccines, Biologics, and Therapeutics

The company will expand the site to include six new containment isolators and a product development manufacturing laboratory.

APIs and Excipients