Author Archives: BPI Staff

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. Meanwhile, 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…

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…

GMP round-up: Samsung Bio becomes bigger, Rentschler fills aseptic gap

Korean CDMO Samsung BioLogics says its third facility is GMP ready and the largest single biomanufacturing plant in the world. Meanwhile, Rentschler has received GMP certification for an Austrian fill/finish plant. Samsung BioLogics has begun production at its third plant at its site in Incheon, South Korea. With 180,000 L of capacity from 12 times 15,000 L tank, the plant is the world’s largest single facility, according to the contract development and manufacturing organization (CDMO). It took Samsung BioLogics 10…

Double deal with Asterias gives Novo Nordisk CA stem cell plant

Novo Nordisk will pay Asterias $2 million to lease a facility in Fremont, California for the supply of stem cell-based therapies. An manufacturing tech licensing deal is also an option. Danish drugmaker Novo Nordisk intends to set up manufacturing capabilities for its clinical phase stem cell therapies for type 1 diabetes and other chronic diseases from 2019 onwards after subleasing the plant in California from Asterias Biotherapeutics. The 44,000 square feet current good manufacturing practices (cGMP) facility is used as…

Alexion refilling pipeline through potential $1.2bn Syntimmune buy

The acquisition of early-phase biotech Syntimmune is “part and parcel” to Alexion Pharmaceuticals’ plan to build up its pipeline, says the firm’s CFO. Alexion Pharmaceuticals has entered into an agreement to buy Syntimmune for an upfront payment of $400 million (€342 million), though milestone payments could see the firm shell out a further $800 million. The deal brings Alexion SYNT001, a humanized monoclonal antibody candidate that inhibits the interaction of FcRn with Immunoglobulin G (IgG) and IgG immune complexes. The…