Biotechpharma UAB BIOTECHPHARMA IS A CONTRACT SERVICES PROVIDER FOR BIOPHARMACEUTICALS Biotechpharma is a contract services provider for biopharmaceuticals. We have expertise in a biotechnological drug substance and drug product development as well as GMP compliant manufacturing. Biotechpharma provides contract R&D services: mammalian cell line and bacterial strain development, USP and DSP process development, protein production process optimization and characterization. We have extensive experience in Biosimilar protein development including MABs (Monoclonal Antibodies). Formulation development for both drug substance and drug product are developed by Biotechpharma. We develop mammalian and bacterial cell lines. Preliminary clone selection, primary biosynthesis optimization steps and expression analysis are performed using regulatory compliant technologies. We have capacities and capabilities to perform development of biosimilars, including MABs (monoclonal antibodies). The fill and finish (F&F) line is designed for liquid or lyophilized products (proteins). 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 is also performed by Biotechpharma. Biotechpharma provides QC testing services. Analytical methods development, analytical methods transfer or analytical methods implementation following pharmacopoeia. cGMP manufacturing of Master and Working Cell Banks (MCB/WCB). Aseptic Cell banking activities are performed within certified laminar flow II biosafety level cabinets with HEPA filtered air Class A. Cells are grown only in qualified incubators. Characterization/testing of MCB/WCB following regulatory guidelines: ICH Q5B, Q5D, Q5A, Q6B, Q7.