The facility expansion includes a single-use 2,000 L mammalian production line with a seeding train consisting of 10L, 50L and 500L bioreactors, along with a cGMP pilot plant for both microbial and mammalian products at the firm’s site in Vilnius, Lithuania.
The expansion cost around €15m, head of Downstream Process Development Nerijus Makauskas told Biopharma-Reporter and came about due to general demand for third-party biomanufacturing.
“The last couple of years were mostly ‘CHO years,’ and mammalian line became a bottle neck,” he said.
With the added capabilities, the contract development and manufacturing organisation (CDMO) has single-use mammalian cell culture capacity at a 30L, 200L, 500L, 1000L and 2000L scale (all through GE brand Xcellerex bioreactors apart from the 30L vessel supplied by Applikon), along with a 300L workin volume stainless steel reactor for high density microbial fermentation.
Taking on the large CDMOs
According to reports, the bio-CDMO space is dominated by Lonza and Boehringer-Ingelheim, both being early players in the space and both having large commercial scale capacity.
It has been suggested single-use systems can help open up the market, and Makauskas said this, along with the firm’s flexibility, could help Biotechpharma compete.
“Understanding the specific challenges of pharmaceutical development programs of our clients, we support them with highest flexibility around our services,” he said, adding speed was also a core value.
“Identifying ourselves with your project and having all our CDMO-capabilities at one location, we help our clients to shorten the time to marke) without compromising quality. Also as a medium-sized company, we keep internal procedures as short as possible, resulting in a high responsiveness to our clients.”
We also asked Makauskas about the market in Lithuania:
“In Lithuania there are couple big players: Teva Sicor, Thermo Fisher Scientific Baltic. Biotechpharma is the only CDMO in Baltic states, and our clients are from USA, China, Western Europe.”
He added the firm is already working with a couple of big pharma companies.