Manufacturing

Workforce training is crucial for biopharmaceutical manufacturing.

Understanding both the challenges and solutions of aseptic manufacturing.

This article summarizes industry views on PAT in bioprocess-related applications and presents a vision for the biopharmaceutical industry to achieve Industry 4.0.

Applying modeling methods in preclinical studies can be a powerful tool for generating data and shortening development timelines.

The SamuxMP enables routine quantification of empty/full AAV capsid ratios

Societal CDMO has been awarded a new manufacturing and packaging task order agreement by National Cancer Institute.

FDA has approved commercial production at Kite’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland.

Catalent will invest $350 million into integrated biologics drug substance and drug product manufacturing at Bloomington, Indiana facility.

The European Investment Bank has provided €15 million to fund coronavirus research at IRBM.

Otsuka Pharmaceutical and Osaka University have entered an exclusive license agreement on a new anti-tumor antibody.

High Purity New England has launched its third facility, focused on single-use assemblies.

ReiThera and Exothera are collaborating to develop a large-scale, low-cost-per-dose manufacturing process to deliver novel vaccines to low and middle-income countries.

Achilles Therapeutics has announced that it will expand its clinical manufacturing capabilities in the UK and enter a partnership agreement for expansion in the US.

Tjoapack has doubled its packaging capacity with the completion of its Netherlands facility expansion.

VectorBuilder will expand with the construction of new $500 million Gene Delivery Research and Manufacturing Campus in Guangzhou, China.

Opus enters a strategic collaboration with Resilience for AAV-based gene therapy development and manufacturing for inherited retinal diseases.

Lonza and Asher Biotherapeutics have entered a manufacturing agreement for a cis-targeted IL-2 fusion protein, AB359.

IAVI and Moderna have announced a new collaboration to employ mRNA technology to meet the challenge of a range of global health issues.

INCOG Biopharma has completed the construction of its cleanroom production area, marking a milestone in the completion of an overall $100 million investment in a new facility.

Catalent has acquired the Vaccine Manufacturing Innovation Centre in Harwell, Oxford to expand its biologics capabilities across the UK and Europe.

Merck has expanded its manufacturing facility in Elkton, Va. to further increase its HPV vaccine supply.

ten23 health is expanding its sterile drug product manufacturing site at Visp, Switzerland to enlarge cold storage and visual inspections capacity and add clean rooms.

Sterling Pharma Solutions has unveiled a £1 million expansion project to increase its capabilities and laboratories capacity at its Deeside, UK site.

UK government has awarded chemical producer Croda a £15.9 million grant to increase the UK’s capacity to manufacture key vaccine ingredients.

The recent success of mRNA vaccines has opened the door for further and future development of nucleic acid-based therapies.

The growing demand for antibody and other bio-therapeutics will require long-term scale-up solutions.

The past year of downstream processing has brought innovations in pH sensitive antibody purification, single-use fermentation separators, and more.

Taking key considerations into account along the cell therapy supply chain can set cell therapy developers up for success.

As process controls adjust to a continuously shifting manufacturing landscape, implementation of information gathered from novel data analysis techniques has become a priority.

Effective cleaning and disinfection along with contamination controls are imperative when operating and utilizing a cleanroom.