Northway Biotechpharma is a flexible biologics contract development and manufacturing organization (CDMO) headquartered in Lithuania with cGMP sites in Vilnius and Boston, MA. As a fully integrated CDMO, the company is well-versed in all aspects of the biopharmaceutical value chain, from cell line development to commercial production and aseptic fill-finish. We are wholly focused on providing high quality, world-class services and long-term partnerships based on our blend of experience and openly collaborative project teams.
We have increased our production capacity for mammalian cell-production by installing an additional production-line up to 2000 L (SUBs). Furthermore, we have added a pilot plant to serve our clients who are in need of small GMP-batches (microbial or mammalian-cell based) and of Master and Working Cell banks.
New, separate production facility with capacity of up to 5,000L bioreactors train to be operational by Q1 2021 at Vilnius site.
Contract R&D, GMP and regulatory services:
Mammalian cell line and bacterial strain development, USP and DSP process development, protein production process optimization and scale-up. We have extensive experience in Biosimilar protein development, including monoclonal antibodies (mAbs).
Formulation development for both drug substance and drug product.
Tech transfer, process characterization and validation, pharma release of both DS and DP by Qualified Person.
While maintaining appropriate segregation, for mammalian projects, Northway use single-use bioreactors to scale-up to 2000 L, and, for microbial projects, Northway is expanding its fermenter size from 300 L to 3000-3500 L working volume (5000 L total volume) in Q1 2021.
Aseptic fill/finish services are offered and include vials, prefilled syringes, and lyophilization. Automated filling machine is used for vials and pre-filled syringes (PFS). Innovative proteins and biosimilars drug products (DP) could be filled, labeled and packaged as well as supplied for clinical trials. Packaging and labeling are also performed by Biotechpharma.
Biotechpharma also provides QC testing services, analytical methods implementation or development, qualification and validation according pharmacopoeia requirements.