In this collaboration, AbCellera will apply its expertise to generate panels of antibody candidates for Gilead to evaluate.

The two countries have been included into the mutual recognition agreement between the European Union and the US FDA that recognizes facility inspections conducted in different territories.

Kingston Pharma LLC received a warning letter after an FDA inspection found violations of current good manufacturing practices including inadequate quality control.

The $10-million investment will include a 500-L single-use perfusion bioreactor and seven patented downstream processing units.

The current president of Novartis’ Advanced Accelerator Applications has been appointed as the new Novartis Pharmaceuticals president.

The acquisition will boost Biogen’s gene-therapy pipeline with the addition of two mid- to late-stage clinical assets and preclinical programs.

Jefferson established the Jefferson Institute for Bioprocessing workforce training institute in collaboration with NIBRT using the GE Healthcare FlexFactory Platform to produce biopharmaceuticals.

Tergus Pharma announced a partnership with Great Point Partners and construction of a new commercial manufacturing facility in North Carolina.

Paul Hudson, formerly CEO of Novartis Pharmaceuticals, has been tapped to succeed Olivier Brandicourt as CEO of Sanofi.

Cambrex has announced the completion of its new facility at its Karlskoga site in Sweden that combines new laboratories for process and analytical development.

EMA has opened a three-month consultation on its draft guidelines on the quality of requirements for drug-device combination products.

A new United Kingdom life-science asset, HIRANI, was launched at a reception at BIO in Philadelphia.

Biotage has announced a strategic collaboration with Shandong Yingsheng Biotechnology for the development of clinical MS applications in China.

ERS Genomics and Bioneer have revealed the signing of a license agreement for access to CRISPR/Cas9 genome editing technology intellectual property.

European midmarket private equity group, Duke Street, has agreed to acquire Kent Pharmaceuticals and Athlone Laboratories from DCC Vital.

CPI, has supported a project focused on developing and integrating novel recombinant prokaryotic lectins (RPLs) into a biosensor-based platform.

Gene therapy development company, bluebird bio, has revealed that the European Commission has granted conditional marketing authorization for Zynteglo.

The SIMCA 16 software has enhanced functionality features that include usability improvements and increased workflow flexibility.

A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.

CDMO iBio introduced cGMP sterile fill/finish services at its facility in Texas.

Although continuous approaches offer significant benefits for some products and processes, batch manufacturing is not going away any time soon.

The US Pharmacopeial Convention released new and revised standards for compounding nonsterile medicines, sterile medicines, and radiopharmaceutical drugs.

Shimadzu’s C2MAP-2030 system can improve operational efficiency for optimizing and controlling the cell culturing process.

Agilent’s updated portfolio of products for immunotherapy researchers provides cell-based tools for translational research and development.

FDA’s annual manufacturing report card shows more quality compliance is needed.

Big Pharma is partnering with Alphabet company, Verily, to modernize clinical trials and accelerate time-to-market for drugs.

A good working relationship between sponsor and contractor will become invaluable when an OOS occurs, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Prestige BioPharma has announced that the EMA has accepted its marketing authorization application for HD201 (Tuzune) for review.