Manufacturing, Biologics

The CHF 400-million (US$416-million) investment in Lonza's biopark in Visp, Switzerland, will expand Ibex Solutions with two new offerings, drug substance development and drug substance and drug product manufacturing.

BeiGene is set to build late-stage clinical and commercial production capacity for cancer monoclonal antibodies with GE Healthcare’s KUBio, the prefabricated biopharma facility based on single-use technologies.

The biopharmaceutical company will invest approximately $800 million to expand facilities and manufacturing capacity at its campus in Rensselaer County, NY.

The provider of plant-based ingredients will present recently launched multi-compendial materials for upstream and downstream biopharmaceutical applications.

Avara Pharmaceutical Services acquired Sandoz’s sterile manufacturing facility for injectable medicines in Boucherville, Quebec, Canada.

The new features on the purifier deliver additional sizes and sterilization/sanitization compatibility.

The collaboration will focus on developing manufacturing solutions for biosimilars.

The company is increasing manufacturing capacity at its Copenhagen, Denmark facility with the addition of six new bioreactors.

The SciLog SciPure FD System from Parker Bioscience is an automated single-use system for the filtration and dispensing of products into either bottles or bags.

Watson-Marlow Fluid Technology Group added a new actuator suitable for applications where reduced weight is a concern.

Automation can improve many aspects of bioprocessing, but several hurdles must be overcome before the full range of benefits can be realized.

Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.

The company is certified as a manufacturer of pressure vessels and components for use in China.

The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.

Dompé Farmaceutici’s Oxervate (cenegermin), a topical eye drop, is the first treatment approved by the agency for neurotrophic keratitis, a rare disease affecting the cornea.

FDA grants support US research in continuous manufacturing monitoring and control techniques for bio/pharmaceutical manufacturing at Rutgers, MIT, and Georgia Tech.

Pharmaceutical scientist association announces upcoming term’s board of directors.

Drug product approval from FDA follows previous approvals from European and Japanese authorities.

The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

Avalon and Weill will co-develop bio-production and standardization procedures for CAR-T therapy.

The companies will collaborate on the discovery, development, and commercialization of cell therapies for cancer.

Boehringer Ingelheim joins Oxford BioMedica, UK Cystic Fibrosis Gene Therapy Consortium, and Imperial Innovations to form a partnership for developing a new gene therapy to treat cystic fibrosis.

The company broke ground on its $200-million, 120,000-ft2 biomanufacturing plant in West Greenwich, RI.

The changing regulatory and manufacturing environment is ushering in a new approach to drug development.

The quality of the cell lines used to manufacture biopharmaceuticals are crucial for the production of high-quality, stable biopharmaceuticals.

The media, by Tosoh Bioscience, is composed of calcium and phosphate buffers and offers mixed-mode properties for biomolecule purification.

CELLforCURE will produce cancer CAR-T treatments for Novartis at a manufacturing facility in Les Ulis (Essonne), France.

Moderna’s new manufacturing plant in Norwood, MA gives the company capacity for preclinical and Phase I and II clinical manufacturing for its mRNA development candidates, including personalized cancer vaccines.

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

Flexibility and process intensification are advantages of continuous biopharmaceutical manufacturing, but some challenges remain.