Upstream & Downstream Processing

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…

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…

Video news: Pall strategic deals aim to enable biosimilar and novel scale-up

Pall Corporation has inked separate partnerships with cell line and expression tech firms Celltheon and Aetos Biologics. The deals help enable both novel and biosimilar manufacturing, the firm says. At the 2018 BPI Conference in Boston, Massachusetts earlier this month, Pall Corporation announced it had entered into a strategic partnership with cell line and expression technology platform development company Celltheon Corporation.   The deal combines Pall’s bioprocessing equipment and consumables with Celltheon’s SMART Expression Platform to offer customers integrated systems…

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…