API Synthesis and Manufacturing, Large Molecule

Report predicts PAT, NIRS, continuous bioprocessing, and a ‘technological arms race’ could improve biopharma manufacturing efficiencies.

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

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

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

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.

The new platform is expected to speed up cell line development.

A new report gives an overview of the work of the International API Inspection Program.

Kemiex trading network is designed to increase safety in the sourcing of APIs and additives.

The new 300,000-square-foot facility is considered the largest dedicated cell and gene therapy manufacturing facility with fully integrated services.

The companies have created Syna Therapeutics, a joint venture that will develop biosimilars and new molecules.

The companies will co-develop and co-promote a CAR T cell therapy in the United States.

The collaboration between the two companies aims to finish all necessary work needed to file for a first-in-human study by early 2019.

The company plans to install 4000-L disposable bioreactors from ABEC at its new commercial manufacturing facility in Wuxi city, China.

Ferring Pharmaceuticals will expand its biologics capabilities at its headquarters and manufacturing site in Saint-Prex, Switzerland.

The new Acquity Arc Bio System by Waters is specifically engineered to enable efficient transfer and improvement of bioseparation analytical methods.

The acquisition will strengthen Sanofi's R&D strategy and expands its franchise for rare blood disorders.

Corning will feature its 3D bioprinting technology and tools to support 3D cell culture at booth #1029 during the SLAS 2018 conference on Feb. 3-7, 2018 in San Diego, CA.

The authors present a robust and easy-to-implement chromatography column performance assessment method, called direct transition analysis (DTA).

BioTek Instruments has released a second edition of its BioSpa software that now offers users a simplified but effective interface for kinetic imaging or detection workflows.

Abzena has entered into a Master Services Agreement with a US biotech company to provide process development and manufacturing services to progress a novel antibody-drug conjugate (ADC) to clinical trials.

In partnership with Indian pharmaceutical firm, Torrent Pharmaceuticals, Novo Nordisk has expanded an insulin manufacturing facility at Torrent’s Indrad, Gujarat, India site.

The companies will co-develop and co-commercialize the lead candidate generated from their earlier collaboration to treat genetic blood disorders.

The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability.