CDMO Lonza has produced the first 2,000 L batch of Tracon Pharmaceuticals’ antibody TRC105 from its Singapore facility after transferring production from the UK.
Californian biopharma firm Tracon has been using Swiss contract development and manufacturing organization (CDMO) Lonza for the manufacture of its lead candidate TRC105 (carotuximab) since the pre-clinical phase of development.
The candidate is an antibody to endoglin – a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation – now in Phase III trials for angiosarcoma.
Tech transfer from the UK to SIngapore has been successfully completed. Image: iStock/LewisTsePuiLung
Using its GS Gene Expression System, Lonza has performed cell-line development and provided clinical supply for TRC105 from its Slough, UK facility, but announced this week the successful completion of a tech transfer to its single-use facility in Tuas, Singapore.
“Client confidentiality means we can’t discuss specifics for Tracon Pharmaceuticals but in general clinical development and manufacturing work are carried out in a range of different scales,” Jenifer Wheat, head of commercial development, mammalian and microbial manufacturing, Lonza Pharma & Biotech, told this publication.
“There are a variety of reasons why clients choose a particular technology or site – our role is to work together with them to help them design the best solution for their particular needs from early stage to commercialization across our broad network of technologies, scales and geographies.”
The CDMO’s Slough site is equipped with a variety of technology, scales and capacities, which Wheat said feeds into the rest of its network as clients move through clinical into commercial.
The Singapore site has both large scale stainless steel (four 20,000 L vessels) and smaller scale single-use assets.
“This is our first batch for Tracon from the single use facility with a view to fulfilling their needs for global commercial supply as they move towards approval,” said Wheat.
“Our team are highly experienced in tech transfers across geographies and technologies. The number of projects and clients we work with across our network mean that this is a regular part of our business, whether clients choose to scale up or expand geographies.”
Ibex expansion
The news comes weeks after Lonza announced an investment of CHF 400 million ($415 million) to expand its Ibex Solutions business at its Visp, Switzerland site, adding end-to-end services for biotech customers.
The services, Ibex Design and Ibex Develop, offer smaller biopharma companies complete product lifecycle management, joining the Ibex Dedicate offering – a service where companies have their own dedicated facilities but plug into the CDMO’s network.
According to Wheat, “the single-use facility in Singapore will be joined by its Ibex Design and Dedicate program that will further expand 2K scale single use in our network.”