Anglo-Spanish firm Aglaris has developed an autonomous, closed production system for the manufacture of cell therapies such as T-cells and MSCs (Mesenchymal Stem Cells). According to new CEO Steven Docksey, the platform overcomes many issues associated with this new product class. “Most current processes are intensive, manual techniques derived and scaled-up from the cell preparation techniques used in research labs – adapting existing tools to the job. There is little in the way of genuine innovation that has come to…
Upstream & Downstream Processing
Eli Lilly to demolish mothballed Erbitux plant in NJ
The former Imclone facility will be knocked down to give Eli Lilly “flexibility for future opportunities†at its Branchburg, New Jersey site, the firm says. Building 36 on Eli Lilly’s Branchburg, New Jersey campus is scheduled to be demolished by the end of the first quarter of 2019, Lilly spokesperson Tamara Ann Hull told BioProcess Insider. “A second building on the same campus – a new, higher capacity, modern facility, Building 50 – has been producing biologics since 2006. Therefore,…
Turning over a new Leaf? Plant-based expression as a disruptor
Plant-based protein expression offers high yields and easy harvesting but has been held back by a lack of funding and the ubiquity of mammalian and bacterial systems, says Leaf Expression Systems. UK-based contract biopharmaceutical development firm Leaf Expression Systems has appointed Simon Saxby, a former executive at contract manufacturing organizations (CMOs) Recipharm and Cobra, as its CEO. Leaf Expression Systems offers the production of proteins, antibodies and vaccines through its Hypertrans expression system, based on tobacco plants. Saxby’s immediate focus…
Hoba (cell) banks on Selexis to advance neuropathic pain program
Selexis will use its SUREtechnology platform to develop a research cell bank to help advance Hoba Therapeutic’s neuropathic pain candidate HB-086. The Danish firm Hoba Therapeutics has selected cell line development firm Selexis to help express viable levels of its clinical candidate HB-086 (recombinant human Meteorin) in Chinese hamster ovary (CHO) cells. The candidate is a 31 kD secreted protein that promotes neurite outgrowth and glial differentiation in the central nervous system. “We do not have a conclusive scientific explanation…
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…
Pandion selects Just to cut cost of bispecific Ab development
Just Biotherapeutics says smart design and optimization of the molecule and the manufacturing process will speed the development of Pandion Therapeutics’s lead bispecific antibody PT101. Just Biotherapeutics has entered into a master services agreement for the development and clinical manufacturing of Pandion Therapeutics’ lead candidate. Pandion is a biotech located in Cambridge, Massachusetts developing bispecific antibodies for the tissue-specific treatment of patients with autoimmune and inflammatory diseases and organ transplants. The firm completed a $58 million (€50 million) Series A…
The POD couple: Pall and G-CON team on modular cleanrooms
Pall’s continuous bioprocessing technologies will be incorporated into G-CON’s prefabricated ‘POD’ cleanroom units in efforts to address current capacity constraint, CAPEX deferment, and cost predictability. G-CON’s PODs are mobile cleanroom units, which include integrated process piping and heating and air conditioning (HVAC) system. A collaboration with bioprocessing vendor Pall Biotech will bring its continuous bioprocessing and viral vector production designs, including automation and utility supplies, to the units. The partnership sets out to solve three needs: contract development and manufacturing…
Emergent extends ABEC disposable deal to equip Maryland plant
Emergent BioSolutions has extended its partnership with vendor ABEC and added a dual purpose single-use system at its site in Baltimore, Maryland. ABEC has shipped a custom designed CSR (Custom Single Run) dual purpose single-use system to Emergent’s Bayview facility, intended for large scale microbial fermentation and mammalian cell culture. “A CSR dual purpose system can operate as a 750 L production microbial fermenter or as a 500L seed bioreactor for Emergent’s 4,000 L CSR bioreactor,†ABEC spokesperson Susan Cooper-Curcio…
Hey Praesto: Purolite opens Protein A plant, opens up resin market
Purolite says its 100,000 L facility will give biomanufacturers the “only credible alternative†for the supply of agarose Protein A resin. The firm claims its chromatography resins can reduce costs by up to 70% compared to the market leading product. This week, Purolite Life Sciences cut the ribbon at a manufacturing facility in Llantrisant Business Park, Wales capable of producing 100,000L of its Praesto range of agarose Protein A affinity resins. Supported by a Welsh government grant, the facility is…
Three-way collaboration looks to scalable purification for AAV
The UK’s Centre for Process Innovation (CPI) will work with CDMO Cobra Biologics and vendor GE Healthcare to reduce the cost of making adeno-associated virus (AAV) vectors. Funded by a £570,000 ($750,000) grant from Innovate UK, the three-way consortium is looking to increase the robustness and reduce costs for the manufacturing of adeno-associated virus (AAV) vectors to feed the growing gene therapy space. The collaboration will see each player contribute its expertise. GE Healthcare’s Puridify fibre-based chromatography technology platform will…