Following a €50 million ($56 million) investment in its biomanufacturing capabilities, Celonic is spending a similar amount to propel itself into the commercial cell and gene therapy space.
Contract development and manufacturing organization (CDMO) Celonic announced last year the construction of a GMP facility at its site in Heidelberg, Germany, increasing clean room area by approximately 2,000 square meters to support clients’ Phase III and commercial biologics programs.
CEO Konstantin Matentzoglu told Bioprocess Insider on stage at BIO that the ‘Halle N’ project, set to begin production in Q2 next year, represented an investment of around €50 million. He added Celonic has “just allocated pretty much the same amount” to create a new facility close to its Basel, Switzerland headquarters to tap the growing demand for cell and gene therapy manufacturing.
|Perfusion at Halle N in Heidelberg
“We already have a phase I and phase II facility in Heidelberg for GMP manufacturing of biologics,” Celonic CEO Konstantin Matentzoglu told Bioprocess Insider as part of the BPI Theater at BIO, Philadelphia in July.
“The new facility will be late-stage phase three, and commercial manufacturing, it will have essentially three 2,000-liter fed-batch bioreactors in each suite.
“In total, six times 2,000 plus, and I think that’s a very strong point of Celonic. We have 1,000-liter perfusion We are probably one of the very few companies worldwide who can really handle 1,000-liter perfusion.”
“The new location will be on the former Syngenta campus,” he said. (Syngenta recently sold its 54,300 square meter campus, situated in the heart of Basel.)
“There we will install probably up to eight independent suites for gene and cell therapy manufacturing. It will be truly multi-product multipurpose. We have not finalized the design but we are looking at something like probably close to 2,000 square meters of capacity for gene and cell services.”
Cell & gene therapy space
Celonic entered the cell and gene therapy space last year with the hire of Soenke Brunswieck, “a veteran in the gene and cell therapy field.”
According to Matentzoglu, Celonic’ decision to jump into commercial manufacturing of such therapies was driven by the firm’s strategy towards production – “we are a fairly commercial organization, so we try to build commercial, we try to get deals prior, we do investment” – and the huge demand from end-users for the relatively small amount of available capacity.
“If you just look at the reports, we see that people nowadays would wait for something like 18 months for a gene vector batch. This makes it really difficult for people who want to bring their products to patients. I think the demand is huge as you rightly say and anybody who would bring capacity online would be able to fill it in no time.”
He added Celonic “as a smaller company” tries to partner strategically and look for more pipeline deals than transactional single molecule or single modality business. “My prediction,” he continued, is “when it’s online, it will be occupied.”