Author Archives: BPI Staff

Stilmas buys MarCor to boost global biopharma water biz

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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,…

December 14, 2018

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

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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…

December 12, 2018

Separate together: Biotage buying purification firm PhyNexus

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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…

December 6, 2018

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

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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…

November 28, 2018

Lonza and Sartorius rejig cell culture media deal

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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,…

November 19, 2018

Rentschler $34m Austrian plant to feed freeze-drying capacity demand

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Rentschler Fill Solutions has inaugurated a €30 million ($34 million) fill & finish facility in Austria. The site will produce Mepsevii (vestronidase alfa) drug product for Ultragenyx Pharmaceutical. Construction of the facility began in July 2016, and the plant received GMP approval in August this year. But today (Friday) the contract development and manufacturing organization (CDMO) officially inaugurated the facility in Rankweil, Austria. The clinical and commercial plant forms part of Rentschler Biotechnologie’s strategic alliance with Leukocare, which aims to…

November 16, 2018

NIIMBL and BPOG publish roadmaps for ADCs, vaccines and gene therapies

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The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), in collaboration with the BioPhorum Operations Group (BPOG), has published a series of technology roadmaps for the biopharma industry. The roadmaps cover manufacturing issues surrounding gene therapies, vaccines, antibody-drug conjugates (ADCs) and bi-specific antibodies, and are based on insight from biomanufacturers, equipment makers, suppliers, academic institutions, non-profits, and federal agencies. They are intended to provide a clear vision of innovation for biopharmaceutical manufacturing processes and platforms and address technology needs and…

November 15, 2018

Abzena adds 2,000L scale through $20m expansion

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Abzena will have two 500 L bioreactors and one 2,000 L bioreactor supplied by Sartorius at its San Diego facility once additional capacity comes online next year. Biologics services firm Abzena has increased its manufacturing capacity through a $20 million (€17.8 million) investment at its drug substance and antibody-drug conjugate (ADC) facility in San Diego, California. “The investment decision has been driven by demand from existing and new customers moving through from cell line development and those already utilizing our…

November 13, 2018

GSK selects Hitachi to make T-cell therapy

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Hitachi Chemical Advanced Therapeutics Solutions (HCATS) will make clinical batches of GlaxoSmithKline’s T-cell receptor therapy targeting NY-ESO-1 from its New Jersey site. The three-year agreement will see HCATS manufacture clinical batches of GSK’s T-cell receptor therapy targeting New York esophageal squamous cell carcinoma 1 (NY-ESO-1). The SPEAR (Specific Peptide Enhanced Affinity Receptor) T‑cell therapy is one of a number of cancer immunotherapies being codeveloped between GSK and Oxford, UK-based Adaptimmune, in a collaboration inked in 2014. The clinical production of…

November 5, 2018

Deal-making digest: IDT’s $80m US contract, WuXi’s strategic partership

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The US National Institutes of Health (NIH) has awarded IDT Biologika a ten-year contract to make biologics and vaccines worth up to $80 million. IDT Biologika has been contracted by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) – an agency of the United States Department of Health and Human Services – to provide process development, manufacturing and characterization of vaccine and biologic products. The German drug and vaccine maker will receive…

October 26, 2018