Manufacturing, Biologics

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.

Increasing demand for biologics is driving the need for innovation in bioprocessing.

Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.

The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.

The company’s next-generation ultraperformance liquid chromatography platform is designed to meet the evolving laboratory requirements for chromatographic performance.

Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.

The company has completed the first phase of expansion at its headquarters in Freiburg, Germany, in anticipation of increasing demand as cell and gene therapies approach commercialization.

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.

Silicone is one of the polymeric materials that can be used for single-use components and assemblies in biopharmaceutical manufacturing.

Understanding differences in bioreactor lifecycle, design space, and product platforms is important for selecting a bioreactor type.

Biosimilars and biobetters have their own unique manufacturing strategies and challenges.

Single-use technologies have become increasingly prevalent in final fill/finish operations for biologics.

WuXi Biologics will invest $60 Million to establish a biologics production facility in Massachusetts.