Manufacturing

Articles

The new facility, which will be Evotec’s first in Europe, will aim to offer capacity, flexibility, and quality for biotherapeutic development and manufacturing while utilizing technology that employs small, automated, highly intensified, and continuous bioprocessing operations inside autonomous cleanrooms.

Evotec Launches Biomanufacturing Facility in France

Catalent’s new mammalian cell culture suites in Madison, Wis. use single-use bioreactor systems for CGMP clinical and commercial manufacturing.

Catalent Completes Expansion of its Biologics Drug Substance Facility in Wisconsin  

The China National Medical Products Administration has given the company the green light to begin manufacturing commercial supply of its approved anti-PD-1 antibody, tislelizumab, at its biologics facility in Guangzhou, China.

China Approves BeiGene for Commercial Manufacturing at its Biologics Facility

Sherri Dolan is a global technology consultant for Virus Clearance at Sartorius North America.

Paul Nolan is a process scientist at Sartorius in Glasgow, Scotland.

Stephen Carey is an analyst at Sartorius in Glasgow, Scotland.

Craig Quinney is a process scientist at Sartorius in Glasgow, Scotland.

Lorna Littlejohn, lorna.littlejohn@sartorius.com, is the manager of Confidence Virus Clearance Services at Sartorius in Glasgow, Scotland.

A series of minute virus of mice spiking studies were performed with a monoclonal antibody product and small-scale AEX membrane adsorbers to evaluate a range of critical processing conditions.

Using Anion Exchange Membrane Adsorbers to Ensure Effective Virus Clearance of Challenging Parvoviruses

The transaction is set to close during the first half of 2021 and is expected to enhance drug substance and drug product capabilities for WuXi. 

WuXi Biologics to Acquire Pfizer China’s Biologics Manufacturing Facilities 

Feliza Mirasol is the science editor for 

Overcoming time and cost constraints can help enable seed train intensification efforts to maximize product yield.

Jumping Seed Train Intensification Hurdles to Maximize Yield

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

Videos

Lessons learned from the pandemic can advance future biologic drug development and manufacturing.


Pandemic Response Lessons

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

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%. 

Manufacturing, Biologics