Drug Development

Articles

The 3M Polisher ST from 3M Health Care is a single-use anion exchange (AEX) chromatography solution intended to replace the reusable AEX polishing column for biologic drug manufacturing.

Chromatography Solution for Biologic Drugs

FDA moves recommended timeline for API and drug manufacturers to assess impurity risks to March 31, 2021.

Nitrosamine Risk Assessment Date Extended

Distribution of the first one-dose vaccine for COVID-19 to start in early March.

J&J Vaccine Approved for Emergency Use

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

To prevent future production delays of critical products, the Biden administration is examining supply chain vulnerabilities for pharmaceutical ingredients as part of a longer-range consideration of products important to public health. 

COVID-19 Vaccine Makers Overcome Challenges to Ramp Up Production

The company will join the network of approved manufacturers of the lipid excipients. 

AMRI to Develop and Manufacture Lipid Excipients for Pfizer-BioNTech COVID-19 Vaccine

New data shows that the COVID-19 vaccines can be stored at standard freezer temperatures for up to two weeks.

Pfizer and BioNTech Submit New Vaccine Stability Data to FDA

Aprecia's compression-free 3DP manufacturing platform and Glatt’s multiparticulate technologies offer solutions to pharmaceutical dosage design challenges.

Glatt and Aprecia Collaborate on 3D-Printing for Solid-Dosage Drugs

The agency issued guidance for developers of vaccines, diagnostics, and therapeutics to address variants of the COVID-19 virus.

FDA Gives Guidance on COVID-19 Variants

Once the vaccine has been authorized, Sanofi will provide Johnson & Johnson with access to its vaccine manufacturing plant in Marcy l’Etoile, France, to formulate and fill vials of the vaccine, at a rate of 12 million doses per month.

Sanofi to Support the Manufacturing of Janssen’s Single-Dose COVID-19 Vaccine

The companies have expanded their existing partnership to include 40 Million Doses of COVID-19 vaccine for South Korea.

Formulation and Drug Delivery