Company Announcements

In August, MilliporeSigma began a collaboration with Angiex, a developer of vascular-targeted biotherapeutic, to speed its lead oncology antibody drug candidate in clinical use. This is the first project for MilliporeSigma’s Massachusetts BioReliance End-to-End Solutions center.

MilliporeSigma opened in September its first BioReliance End-to-End Biodevelopment Center in Asia Pacific, located in Shanghai, China. Services provided by the facility include cell line development, upstream and downstream process development, and non-GMP clnical production. It will host small-scale drug manufacturers working on early-phase clinical trials.

In September, MilliporeSigma provided an update on its participation in the EU Horizon 2020’s nextBioPharmaDSP project, led by Lek Pharmaceuticals, a Sandoz company. The project, undertaken by a consortium of seven public and private organizations, is developing a more efficient, cost effective and environmentally friendly downstream process to manufacture mAbs. MilliporeSigma is providing expertise in continuous and flow-through downstream processing approaches and single-use systems. Recently, the project completed an 18 month milestone submission to the EU. Developments include a disposable continuous chromatography system with novel analytical tools and sensors, which are also implemented in other parts of the downstream process.

In October, MilliporeSigma announced the completion of a US FDA Pre-License Inspection and EMA Marketing Authorization Application inspection of its Carlsbad, California–based manufacturing facility for the production of BioReliance viral and gene therapy products.

Sartorius Stedim Cellca, which currently employees 90 people, broke ground in September on a €30 million ($33 million) Cell Culture Technology Center in Ulm, Germany. The new lab and office complex will approximately double the company’s space and is expected to be completed by the end of 2019.

Product Introductions

In September, Esco VacciXcell launched the new TideCell bioreactor in the US. The company calls it the world’s largest single-use linearly scalable bioreactor for adherent cell scale up to 5,000 L packed-bed volume. New features include a standard hypoxic condition (suppressed oxygen) that is optimal for the growth of bone marrow–derived mesenchymal stem cells and exosomes, as well as the PC-based monitoring and control system.

Sales/Orders of Note

In September, Sartorius Stedim Biotech announced the purchase of its ambr 250 modular bioreactor system by industrial biotechnology firm Ingenza for fast fermentation development.

MilliporeSigma announced in September the sale of five Mobius single-use bioreactors, 50 L, 200 L and 2,000 L systems, to CDMO firm Celonic for its Basel, Switzerland, facility.

In October, ABEC announced that Emergent BioSolutions will equip its Baltimore, Maryland, bulk manufacturing facility with an ABEC 4,000 L CSR single-use bioreactor.