Author Archives: BPI Staff

Boehringer expanding China CDMO plant

Boehringer Ingelheim has begun an expansion at its biomanufacturing facility in Shanghai as it looks to tap the “great potential in China.” The expansion at the site in Shanghai covers an additional bioreactor and will include the necessary utility and infrastructure to support GMP operations of two 2,000 L single use bioreactor manufacturing lines. When asked, the Germany-headquartered firm did not divulge further details on the specifics of the investment. Boehringer Ingelheim spent more than €70 million in the first-phase…

Solentim and ATUM team partner for cell line development service

The collaboration brings together instrumentation with expression technology to create what the firms say is “the most efficient cell line development solution for biotherapeutic drug developers yet.” The collaboration – financials of which have not been divulged – aims at overcoming the bottlenecks in biomanufacturing by establishing and isolating the most suitable cell lines for a drug candidate. The combined offering will appeal to “pharmaceutical and biopharma companies wanting to shorten their cell line development timelines and make sure they…

Selexis and Agenus expand immune-oncology cell line deal

After an initial collaboration in 2015, Selexis has signed commercial license agreements with Agenus to develop research cell banks for additional antibody programs. In 2015, clinical-stage immuno-oncology firm Agenus selected cell line development firm Selexis to collaborate on its lead anti-CTLA4 (AGEN1884) and anti-PD1 (AGEN2034) programs. Four years on and the firms have extended the deal to include the use of Selexis’ SUREtechnology platform with additional novel single agent and combination therapies. “Under the expanded collaboration, Selexis will continue to…

Univercells to scale-up sub 30 cent polio vaccine platform

A Univercells-led consortium has received a grant extension to scale-up a manufacturing platform it claims can slash the cost of inactivated polio vaccines. In December 2016, a consortium led by Belgium biomanufacturing technology firm Univercells received a $12 million (€10.4 million) grant from the Bill & Melinda Gates Foundation to develop a low-cost vaccine manufacturing platform. The consortium also involves Batavia Biosciences which has developed the polio manufacturing process and Natrix Separations (now owned by MilliporeSigma) for the purification membrane.…

Teva two: FDA approves Celltrion-made Herceptin biosimilar

The US FDA has approved a second biosimilar of Roche’s breast cancer drug Herceptin (trastuzumab): Celltrion’s Herzuma, to be marketed by Teva. In 2016, Israeli firm Teva Pharmaceutical Industries expanded its biosimilar portfolio by teaming up with Korean drugmaker Celltrion. The $160 million (€141 million) deal gave Teva the US rights to versions of Roche’s Rituxan (rituximab) and Herceptin. The former received US Food and Drug Administration (FDA) approval last month, and now the latter has been given the regulatory…

Stilmas buys MarCor to boost global biopharma water biz

Stilmas Americas has been formed from the acquisition of Canada’s MarCor, bringing its purified water and water for injection (WFI) solutions to North America. The deal sees Stilmas add the high purity division of MarCor to its business. Finanacial details have not been divulged. Stilmas is a subsidiary of the Masco Group, a conglomerate which offers engineering, pure media systems – including WFI stills, purified water systems, pure steam generators – and super skid preparation systems to the biopharma industry,…

MacroGenics clinical hold has no wider implications for bispecifics, say analysts

The US FDA has placed a partial clinical hold on MacroGenics’ CD3 bispecific candidate MGD009 following reports of hepatic adverse events. On December 6, the US Food and Drug Administration (FDA) sent Maryland-based clinical-stage biopharmaceutical company MacroGenics a letter indicating that a partial clinical hold has been placed on its Phase I monotherapy study of MGD009 and a combination study of MGD009 and MGA012 (anti-PD-1). No new patients will be enrolled in either study until the partial hold is lifted…

Separate together: Biotage buying purification firm PhyNexus

Swedish separations firm Biotage will add lab scale purification technology through its acquisition of PhyNexus. Financial details of the deal have not been divulged, but the California-based private firm PhyNexus has agreed to be acquired by Biotage this week. PhyNexus will bring an enabling automation platform based on Dual Flow Chromatography to Biotage’s bioprocess offering and increase the firm’s place in the downstream space. The technology enables miniaturized and parallel automated work-flows to address different laboratory purification processes. The Dual…

Small molecule M&A round-up: Roche buys Jecure, Arsanis and X4 merge

Bored of biologics? Tired of T-cells? Well BioProcess Insider takes a look at some of the big developments in the small molecule world. First up in this compendium is Swiss pharma giant Roche. The firm has acquired San Diego, California-based Jecure Therapeutics through its Genentech division. While Genentech is synonymous with biologics, Jecure’s business focuses on small-molecule therapeutics for the treatment of non-alcoholic steatohepatitis (NASH) and liver fibrosis. Its lead candidate is an inhibitor of Nucleotide-binding oligomerization (NOD)-like Receptor Family…

Lonza and Sartorius rejig cell culture media deal

Lonza says cell culture media is no longer simply a consumable but a critical part of the biomanufacturing process as it modifies its supply deal with Sartorius. In December 2012, contract development and manufacturing organization (CDMO) Lonza teamed up with bioprocessing equipment and consumables supplier Sartorius Stedim Biotech (SSB) for the supply and distribution of media and buffers used in the manufacture of protein-based therapeutics and vaccines. A shift in the arrangement now sees supply continue but under non-exclusive terms,…