The new building includes biosafety level (BSL) 2 Grade B/C cleanrooms supporting host-cell expansion suites, upstream processing capacity at 500L single-use-bioreactor production, and separate downstream purification suites, said the CDMO.
With the first construction milestone complete, Vibalogics will now progress GMP manufacturing campaigns for multiple clients currently contracted to the Cuxhaven facility.
“Capacity utilization remains high for 2022, with some development and production contracts already extending GMP campaigns into 2024, however select opportunity to secure production through the expansion suites still remains,” it said.
The project is a part of an overall $50M (€43m) investment in the 100,000 ft2 (9,400 m2) facility.
Additional expansion
The CDMO is now planning the second phase of expansion in through design and construction of additional process development and quality control testing laboratories set to commence early this year.
The Cuxhaven campus provides fully integrated service offerings for preclinical through phase I-II oncolytic virus, viral vector gene therapy, and vaccine programs including cell and virus banking, process and analytical development, drug substance manufacturing, drug product fill-finish of liquid and lyophilized products, quality control batch release testing, and stability studies.
Late phase and commercialization services are offered at Vibalogics’ new Boxborough, Massachusetts facility, which completed late 2021; it is set up to provide an end-to-end service for virotherapy products.
The company outlined how those infrastructure improvements have been coupled with strengthened operations and expansion of its global executive leadership team including CEO, Tom Hochuli, formerly head of cell and gene therapy operations at Lonza, Houston, among other key hires, and promotion of company veteran, Kai Lipinski, to CSO, along with formation of its scientific advisory board.
It expects to expand to over 200 employees by year end.
New owner
The CDMO was prized by new owner, Recipharm, for its capabilities in new biologics modalities, its expertise in oncolytic viruses, viral vaccines, and viral vector gene therapies.
“Vibalogics is responding to the rapidly growing biopharmaceutical industry demand for specialized CDMO capabilities for the manufacture of live viruses and viral vectors including Herpes Viruses, Pox Viruses, Adenoviruses, and other viral classes for cancer and other applications.
“The company has seen rapid growth of its global customer base comprised of Big Pharma, mid-sized biotechs and start-ups requiring its unusual process expertise, capabilities and capacity for virus production. Continued investment, including its recent expansion in Germany and the US, has positioned it to support the full product lifecycle of its clients,” said the Swedish firm following announcement of the deal last month.
