May 15, 2019
Patheon will produce an antibody for Cantargia; GI Innovation has signed a second development services deal with Samsung BioLogics; Sekisui Diagnostics is growing its contract microbial manufacturing business. Welcome to Bioprocess Insider’s CDMO round-up.
First up in our contract development and manufacturing organization (CDMO) round-up is news from Thermo Fisher’s Patheon, which has been selected to produce CAN04 (nidanilimab) for Cantargia AB.
Cantargia already has a contract in place with Celonic (formerly Glycotope Biotechnology) for clinical supply of the monoclonal antibody but the agreement with Patheon secures additional supply as it progresses through the clinic. CAN04 is currently in phase IIa trials for non-small cell lung cancer and pancreatic cancer.
Under terms of the deal, Patheon will scale up the process to 2,000 L before the next production campaign of clinical material. Financial details have not been revealed.
Next up, and Samsung BioLogics will provide contract development services for fellow Korean firm GI Innovation.
The CDMO, which launched its contract development organization (CDO) offering in 2018, will provide the bio-venture company services from cell line development to Phase I drug substance production for an undisclosed candidate said to be a microbiome-protein combination drug.
“Thanks to Samsung BioLogics’ CDMO business, we can overcome the problem of producing high quality clinical test samples, the biggest barrier of bio venture companies,” said Soo Yeon Nam, CEO of GI Innovation.
“We are very positive that global pharmaceutical companies interested in the R&D pipeline of GI Innovation will be able to access global new drug licensing (BLA) and biotech drug business through Samsung BioLogics’ CDMO service.”
This is GI Innovation’s second contract with Samsung BioLogics following a project inked between the two firms in June last year.
Sekisui Diagnostics jumped into the microbial biologics CDMO in 2017 and now the Massachusetts-based firm will expand its presence through a $1.9 million (€1.7 million) investment in its new BioProcess Innovation Center at its site in Maidstone, Kent, UK.
The center will more than double the firm’s development laboratory space to aid process development and support its 20 L to 5,000 L recombinant microbial manufacturing services.
“Over many years we have built both a technical and operational competency and expertise in enzyme production and microbial fermentation,” Robert Schruender, CEO of Sekisui, said. “As the Biopharma CDMO market grows, we aim to further leverage this capability to grow our share in this market.”
The expansion is set to be completed by the end of the year.
And finally, sticking with microbial expansions, Vilnius, Lithuania-based CDMO Biotechpharma is upping its fermentation capacity to 5,000 L through a €50 million ($56 million) investment.
“The expansion comes amid growing global demand for flexible and responsive outsourcing partners that are able to support the full product lifecycle, from upstream and downstream process development and optimization to GMP manufacturing of drug substance and formulated drug product,” said Vladas Bumelis, chairman of Biotechpharma’s board.
The microbial capacity complements the CDMO’s two lines of 1,000 L and 2,000 L for mammalian cell production, both equipped with single use bioreactors.
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