Author Archives: BPI Staff

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…

AGC adds mammalian capabilities to Japanese network

Demand for mammalian biomanufacturing services has led AGC Bio to invest in its facility in Chiba, Japan. Contract development and manufacturing organization (CDMO) AGC Bio is adding a new facility at its site in Chiba containing single-use bioreactors at the 500 and 2,000 L scale. The plant, expected to be operational by the second half of next year, will produce monoclonal antibodies (MAbs), fusion proteins and other types of therapeutic proteins for its customers. “The facility is being established for…

BIA Separations opens upstream lab; looks to future expansions

The newly opened lab looks to optimize the interface between upstream and downstream processing, says Slovenian bioprocessing firm BIA Separations. Developed on the back of customer demand, the upstream processing laboratory aims to optimize the critical interface between upstream and downstream processing for the production of complex molecules and biologics. BIA Separation CEO Aleš Štrancar said that product-contaminant complexes formed during upstream production represent a consistent and challenging obstacle for downstream processing. “These complexes interfere with every aspect of bioprocessing…

Shire buys sanaplasma AG to support immunology business

Shire adds 14 centers to its European-based plasma collection network through an acquisition aimed at extending long-term plasma supply. Plasma is essential to the manufacture of immunoglobulin therapies for certain rare immunological diseases. Shire, which prides itself on orphan and hemophilia drugs, has more than 100 plasma collection centers in the US and Austria and has further expanded its presence through the acquisition of sanaplasma AG. “The transaction was an acquisition of 100% of sanaplasma AG,” Shire spokesperson Paris Barker…