Manufacturing

Articles

The guidance document provides recommendations for reporting and implementing changes to container closure system components consisting of glass vials and stoppers for sterile drug products.

FDA Publishes Guidance on Changes to COVID-19 Container Closure Systems

Feliza Mirasol is the science editor for 

While manufacturing increases have been implemented for vials and syringes, meeting future market needs remains unpredictable.

Increases in Manufacturing Capacity Target Vial and Syringe Shortages

CDMOs address the unique challenges of liquid and lyophilized forms as well as preparing for the large capacity needed for COVID-19 vaccines.

Meeting Fill/Finish Challenges for COVID-19 Vaccines

Cytiva acquired Vanrx Pharmasystems, a Canadian manufacturer of robotic aseptic filling equipment.

Cytiva Acquires Vanrx Pharmasystems

Clinical material for a Theratechnologies product in development will be produced at PPS’ manufacturing facility in Lexington, KY.

Piramal Pharma Solutions to Provide Sterile Fill/Finish Support to Theratechnologies

The companies have entered into an agreement to support the formulation and fill/finish of Moderna’s COVID-19 vaccine supply outside of the United States. 

Moderna and Recipharm Announce COVID-19 Vaccine Supply Agreement 

The company is investing in expansion at four sites in the United States, United Kingdom, and Italy, which will include construction of new facilities and addition of sterile and lyophilized filling lines.

Thermo Fisher Scientific Expands Sterile Drug Product Development and Commercial Manufacturing

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

A holistic approach to validation and quality assurance is essential.

Prepping Fill/Finish Systems to Ensure Quality Output 

The expansion will include a new 25,000-ft2 warehouse, a filling line for flexible plastic containers, a high-speed automated syringe fill line with the ability to fill up to 600 units per minute, and a high-speed automated visual inspection line.

Baxter to Invest $50 Million into Indiana Fill/Finish Manufacturing Facilities Expansion

The 110,000 ft2 site, which is set to be operational by the second half of 2021, will feature new technology including 2000-L scale bioreactors and additional fill-finish capabilities.

Manufacturing, Fill/Finish