Upstream & Downstream Processing

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 AleÅ¡ Å trancar 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…

Exclusive: Samsung BioLogics poised to enter cell therapy space

After building three large-scale biomanufacturing plants, CDMO Samsung BioLogics has told BioProcess Insider it is adding single-use capacity and is considering expanding into stem cell therapy services. It has been nine years since Samsung BioLogics entered the third-party biologics space, in which time it has brought two commercial biomanufacturing facilities online with a third expected to be fully validated by the end of this year. When operational, the firm’s site in Incheon, South Korea will boast a total of 362,000…

Sanofi deal shows demand for CHO alternatives, says Dyadic

Sanofi-Aventis Deutschland has teamed with Dyadic to test the potential of the C1 fungus-based expression system for the manufacture of biologics and vaccines. The fully funded proof of concept research deal will see Sanofi-Aventis use Dyadic International’s C1 platform to overcome specific gene expression challenges across some of its vaccine and protein-based biologics “Sanofi sees huge value in C1 and the future of bioprocessing and biomanufacturing efficiencies with such a power horse and we are excited for the collaboration as…

Thermo Fisher back on the M&A train through BD buy

The addition of BD’s Advanced Bioprocessing business will boost Thermo Fisher Scientific’s cell culture media formulations offering. At the BioProcess International Conference in Boston, Massachusetts last week, news broke that equipment and reagent supplier Thermo Fisher agreed to buy the Advanced Bioprocessing business of medtech firm Becton, Dickinson and Company (BD). The business, which clocks in around $100 million (€86 million) annually, will add several peptones that enhance cell culture media formulations, aimed at improving yield and reduce variability in…

BioMarin building $50m Irish fill/finish plant for orphan enzymes

The drug product plant in County Cork will support the fill and finish of BioMarin’s rare disease drugs Vimizim (elsulfase alfa) and Brineura (cerliponase alfa). The filling facility at BioMarin’s site in Shanbally, County Cork represents an investment of €43 million ($50 million) and will create 51 additional jobs. “We regularly evaluate our manufacturing capabilities and which capabilities we do ourselves and which make sense to outsource,†BioMarin spokesperson Debra Charlesworth told BioProcess Insider. “Based on our current business needs…

Vendors ‘awakening’ to the needs of cell and gene therapy makers

Equipment suppliers are vying to fill gaps in processing say cell and gene therapy experts, but understanding what end-users need will be central for success. In 2017, the US FDA approved two chimeric antigen receptor T (CAR-T) cell therapies. Since then there have been several other cell and gene therapies approved across several markets, including Europe’s first allogeneic stem cell in the form of Takeda’s Alofisel (darvadstrocel). And with several hundred cell and gene candidates moving through the clinical stages…

Sartorius combination tech deal a ‘win-win,’ says Repligen

Bioprocessing vendors Sartorius Stedim Biotech and Repligen Corporation have combined their bioreactor technologies to offer control integrated bioreactors for perfusion. Announced at the BioProcess International Conference in Boston this week, Sartorius and Repligen have inked a deal to integrate their respective technologies into a combined offering for biomanufacturers. Under terms of the deal, Repligen’s XCell ATF cell retention control technology will be combined into Sartorius’ BIOSTAT STR large-scale single-use bioreactors offering customers bioreactors used in perfusion cell culture applications between 50…

KBI boosts analytical services with Belgium expansion

The laboratories in Belgium will help international biopharma firms consolidate their outsourced analytical work to meet EU regulations, says KBI Biopharma. Contract development and manufacturing organization (CDMO) KBI Biopharma has opened laboratories in Leven, Belgium offering analytical development, formulation development, biopharmaceutical characterization and cGMP quality control testing. According to CEO Tim Kelly, the lab expansion was first announced in 2015, when the CDMO was acquired by JSR Corporation. “JSR’s decision to expand its A3 production capacity in Leuven created an…