americanpharmaceuticalreviewApril 18, 2019
Tag: Biotechpharma , GMP , Process Development
Biotechpharma UAB announced further expansion of its fermentation capacity to 5,000 L, along with an additional state-of-the-art process development laboratory, investing more than €50 million in the expansion.
"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," Dr. Vladas Bumelis, Chairman of the Board, said.
With the new capacity, Biotechpharma continues to advance its mission of becoming a single-source CDMO able to support its worldwide customers with a full range of development and manufacturing services to support clinical and commercial manufacturing.
"We are thrilled to announce this latest expansion of our infrastructure, as it will allow us to better support our customers’ biological development programs with quality, speed and flexibility of service," said Giedrius Žunda, CEO of Biotechpharma.
The new plant in Europe, located at the company’s site in Vilnius, Lithuania, will contain a new line of bioreactors for microbial fermentation at 5,000 L scale and the necessary equipment for downstream processing operations. Flexible facility design will also allow for increased mammalian cell culture production capacities in addition to the already existing two lines of 1000-L and 2000-L scale for mammalian cell production, both equipped with single-use bioreactors. Completion of the plant, which should be operational in Q4 2020, will result in an increase in Biotechpharma’s volume capacity by nearly a factor of two.
"With this latest expansion and plans for continued growth, we are better positioned than ever to meet the growing global demand for these specialized capabilities –– and to become a fully integrated biopharmaceutical CDMO," said Frank Ternes, CBO of Biotechpharma.
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