Poly adenosine diphosphate ribose polymerase (PARP) inhibitor Rubraca® (rucaparib) is indicated for the treatment of breast cancer susceptibility gene (BRCA) mutation-linked advanced ovarian cancer.
Biovian is a one-stop-shop providing good manufacturing practices (GMP) contract manufacturing of biopharmaceuticals. The company offers a wide range of services from early development to aseptic fill and finish.
Biovian provides a full range of services including process development, cell cultivation, protein purification, and product’s fill and finish. Biovian’s GMP facilities are Europeans Medicines Agency (EMA) certified and Food and Drug Administration (FDA) inspected, which together with state-of-the-art equipment enables flexible pilot production and development services.
GMP contract manufacturing
Biovian offers contract manufacturing services including GMP contract manufacturing of biopharmaceuticals and recombinant proteins. The company also carries out GMP protein purification processes, GMP cell culture (mammalian and microbial), and GMP aseptic fill and finish.
Biopharmaceuticals for commercial and investigational GMP use
Biovian provides contract GMP manufacturing of biopharmaceuticals from milligram scale to hundreds of grams.
Recombinant protein production for research and drug development purposes
Biovian carries out recombinant protein production using yeast, microbial, mammalian and insect cell cultivation, and protein purification.
Biovian’s technologies for cultivation are conventional stirred-tank bioreactors and disposable suspension cultivation systems.
The company offers hosts such as mammalian cells, yeast, bacteria, and insect cells.
Protein purification involves:
- Membrane processes
- Varieties of chromatographic methods
- Virus removal and inactivation development and validation
- DNA and host cell removal and validation
Formulation and stability
Biovian offers formulation development for biopharmaceuticals, stability studies, and end products and intermediates.
Analytical methods and quality control (QC) analysis
- High-performance liquid chromatography (HPLC)
- Sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE)
- Western blotting
- Isoelectric focusing (IEF)
- Peptide mapping
- Total protein
- Host cell protein
- Residual DNA
- Total organic carbon (TOC)
- Microbial challenge tests
Contract research and development
Biovian’s contract research and development services include cell cultivation and protein purification process development, assay development and protein characterisation.
Analytical quality control services
Biovian offers quality control analytical services supporting GMP drug manufacturing which comply with the Ph.Eur and USP services, which include sterility, endotoxin, and bioburden testing.
Aseptic filling and finishing
Biovian offers aseptic filling and finishing current good manufacturing practice (cGMP) services including aseptic filling in vials. Typical vial sizes are 2ml to 15ml. If required, lyophilisation of the drug product is also offered. The sterile manufacture of injectables is offered for investigatioinal and commercial use. Biovian’s high-value package of aseptic filling services also includes full QC testing, individual labelling, colour coding, and warehousing, as well as qualified person (QP) release and delivery to a designated trial site.
Biovian is located in Finland, in the heart of Turku Science Park, and has excellent connections through both Turku and Helsinki international airports.
Biovian’s inspected 3,400m² cGMP facilities contain EU grade A, B, C, and D class cleanrooms, as well as warehouses under full quality control and extensively equipped development laboratories. The company holds manufacturing authorisation from EMA and complies fully with the EU GMP. Biovian’s facilities are also FDA certified and inspected. Biovian has biosafety level 1 and 2 laboratories and is capable of handling micro-organisms classified to GMM1 and GMM2. Biovian has been also inspected by the Finnish Board for Gene Technology.
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