Biovian - Contract Manufacturing Of Biopharmaceuticals

Biovian is a one-stop-shop that provides cGMP contract manufacturing of biopharmaceuticals. We offer a wide range of services from early development to aseptic fill and finish.

Biovian provides a full range of services including antigen isolation, cell line development, process development, cell cultivation, protein purification, and product fill and finish. Biovian’s cGMP facilities and state-of-the-art equipment enable flexible pilot production and development services.

cGMP contract manufacturing

Biovian offers contract manufacturing services including cGMP contract manufacturing of biopharmaceuticals and cGMP contract manufacturing of recombinant proteins. We also carry out cGMP protein purification processes, cGMP cell culture (mammalian and microbial) and cGMP aseptic fill and finish.

Biomolecules for the diagnostic industry

Biovian provide contract manufacturing of antibodies from milligram scale to hundreds of grams.

Recombinant protein production for research and drug development purposes

We carry out recombinant protein production using yeast, microbial, mammalian and insect cell cultivation, and protein purification.

Contract research and development

Our contract research and development services include expression vector construction and cell line development, cell cultivation, protein purification, process development, assay development, and protein characterization.

Analytical quality control services

Biovian offers quality control analytical services supporting GMP drug manufacturing which comply with the Ph.Eur. and USP. Services include sterility testing, endotoxin testing and bioburden testing.

Expression vector construction and cell line development technologies

Expression vector construction and cell line development technologies include vector cloning and transfections, gene amplification, clone selection and medium optimization.

Hosts

We offer hosts such as mammalian cells, yeast, bacteria and insect cells.

Cultivation

Our technologies for cultivation are conventional stirred-tank bioreactors, disposable suspension cultivation systems, and hollow-fibre reactors for both bench-scale and large-scale antibody production with emphasis on diagnostic use.

Protein purification

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 offer formulation development for biopharmaceuticals, stability studies and end products and intermediates.

Analytical methods and QC-analyses

• Immunoassays
• HPLC
• SDS-PAGE
• Western blotting
• IEF
• Peptide mapping
• Total protein
• Host cell protein
• Residual DNA
• Endotoxin
• Sterility
• TOC
• Bioburden
• Mycoplasma
• Microbial challenge tests

Aseptic filling and finishing

Aseptic filling and finishing cGMP services include aseptic filling in vials. Typical vial sizes are 2ml to 15ml. If required, lyophilization 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, as required, full QC testing, individual labelling, colour coding and warehousing, as well as QP release and delivery to a designated trial site.

Biovian facilities

Biovian is located in Finland, in the heart of Turku Science Park with excellent connections through both Turku and Helsinki international airports.

Biovian’s inspected 1,600m² cGMP facilities contain EU grade A, B, C and D class clean rooms and warehouses under full quality control, as well as extensively equipped development laboratories. Biovian holds manufacturing authorisation from NAM (Finnish National Agency for Medicines) and complies fully with the EU GMP. 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.