Author Archives: BPI Staff

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,…

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

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…

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

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…

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

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…

GSK selects Hitachi to make T-cell therapy

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…

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

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…

BioProcess International Conference and Exhibition 2018 Postevent Report: Key Insights, Highlights, and Take-Away Messages

From the global shift in demographics to increased efficiencies in chromatography media, change is constant within the bioprocessing industry and a major reason delegates flock to the annual BPI Conference and Exhibition. As a place to get an overview of the hot topics affecting this industry, the meeting brings together key aspects of bioprocessing — therapeutic modalities, cells, expression systems, upstream production, downstream processing, development, and manufacturing — with digital integration and the increasing importance of analytics. Add in macrobusiness…

MaSTherCell wins Iovance deal as commercial cell therapy demand increases

Cell therapy CDMO MaSTherCell will produce late-stage clinical supply of an adoptive cell therapy for Iovance Biotherapeutics from its facility in Belgium. Iovance has selected MaSTherCell S.A., a cellular therapy-focused contract development and manufacturing organization (CDMO) and subsidiary of Orgenesis, to manufacture an adoptive cell therapy using its tumor infiltrating lymphocyte (TIL) product as it goes into late-stage trials in Europe. The manufacturing will take place from MaSTherCell’s plant based in Belgium, which according to a spokesperson from the CDMO…

In-house investments let Synthon keep control of ADC production

Synthon Biopharmaceuticals chose to develop its antibody-drug conjugate (ADC) capabilities in-house to keep control of planning and product quality. Aad Van de Leur, COO of Synthon Biopharmaceuticals, spoke at KNect365’s Bioproduction Congress in Dublin, Ireland this week on the need to adapt biomanufacturing strategies and technologies for next generation therapies, using his own firm’s antibody-drug conjugate (ADC) capabilities as an example. “With the introduction of innovative high-potent biopharmaceuticals like antibody-drug conjugates (ADCs) the industry had to adapt and move to…

Sanofi and Regeneron gain approval for skin cancer MAb

The US FDA has approved skin cancer drug Libtayo, a programmed cell death protein-1 (PD-1) inhibitor developed through a Sanofi and Regeneron collaboration. In 2007, Sanofi teamed up with Regeneron Pharmaceuticals to discover, develop, and commercialize fully-human therapeutic antibodies. While the discovery collaboration ended last year, Sanofi still owns a 22% stake in Regeneron. The the firms also continue to develop and commercialize a number of monoclonal antibodies, including its metastatic cutaneous squamous cell carcinoma (CSCC) product cemiplimab which the two…