Drug Development

Articles

The companies will collaborate on the manufacturing, clinical development, and regulatory activities for Novavax’s COVID-19 vaccine in Japan.



Takeda and Novavax Team Up for COVID-19 Vaccine Development in Japan

The CDMO will offer capacity for manufacturing and distributing COVID-19 vaccines and therapeutics at its Grand Rapids, MI, fill/finish facility. 

Grand River Selected for Operation Warp Speed Efforts

Sanofi and GlaxoSmithKline have been selected to supply the US government and the European Union with millions of doses of their COVID-19 vaccine candidate.

Sanofi and GSK to Supply COVID-19 Vaccine to US Government and European Union

The company is working to ensure broad global access to its COVID-19 vaccine candidate, following approval from regulators.

J&J in $1-Billion Agreement with US Government for 100 Million Doses of Investigational COVID-19 Vaccine

The companies have agreements to supply its mRNA-based COVID-19 vaccine to Japan and Canada, pending regulatory approvals in those countries.

Pfizer and BioNTech to Supply Japan and Canada with mRNA-Based COVID-19 Vaccine Candidate

The use of analytical assays is crucial for determining that biosimilar critical quality attributes remain on point.

Using Analytical Assays to Ensure Biosimilar Quality

Flora J. Keumurian, florak@mit.edu, is program and operations manager, MIT Center for Biomedical Innovation.

Michael E. Wiebe, mewiebe@mit.edu, is lead investigator, CAACB, and principal at Quantum Consulting, MIT Center for Biomedical Innovation.

Jacqueline Wolfrum, jwolfrum@mit.edu, is co-director, Biomanufacturing Program, and director, BioMAN, MIT Center for Biomedical Innovation.

James C. Leung, leungjc@mit.edu, is lead investigator, CAACB, and senior research fellow, MIT Center for Biomedical Innovation.

Anthony J. Sinskey, is faculty director, MIT Center for Biomedical Innovation; Professor of Biology, MIT, asinskey@mit.edu.

Stacy L. Springs, ssprings@mit.edu, is senior director of programs and executive director of Biomanufacturing Initiatives, MIT Center for Biomedical Innovation.

This article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations. 

The Impact of SARS-CoV-2 on Biomanufacturing Operations

Esra’a Albarahmieh is associate professor, Pharmaceutical Chemical Engineering department of the School of Applied Medical Sciences, German Jordanian University.

Mohammad Khanfar is associate professor, Pharmaceutical Chemical Engineering department of the School of Applied Medical Sciences, German Jordanian University.

Emad Alzubi is instructor and workshop manager at the Industrial Engineering department of the School of Applied Technical Sciences, German Jordanian University.

This study suggests that using a simple centrifugal method can produce a natural polymer-blend molecule that can successfully be used as an oral delivery mechanism for poorly soluble drugs. 

Fabrication Modulation of Zein-based Fibers for Oral Delivery of Hydrochlorothiazide

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

Particle engineering is a useful tool to manipulate API particles into a form that is manufacturable and deliverable to the patient.

A Great Manipulation: The Value of Engineering Particle Properties

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

Understanding and overcoming excipient variation are crucial for successful continuous processes.

Formulation and Drug Delivery