Biovian

Contract Manufacturing Of Biopharmaceuticals

Biovian is a one-stop-shop providing GMP contract manufacturing of biopharmaceuticals.

Biovian is a one-stop-shop providing GMP 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 and process development, cell cultivation, protein purification, and product's fill and finish. Biovian's GMP facilities are EMA and FDA certified, 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 GMP contract manufacturing of recombinant proteins. We also carry 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

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

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.

Cultivation

Our technologies for cultivation are conventional stirred-tank bioreactors, disposable suspension cultivation systems.

Hosts

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

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

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.

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 2,300m² 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 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.

Contact Details

Biovian Ltd
Tykistökatu 6B, Biocity
FIN-20520 Turku
Finland
antti.nieminen@biovian.com
contact@biovian.com
knut.ringbom@biovian.com
www.biovian.com

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From Gene to Finished Vial 19 October 2016 Biovian is a one-stop-shop in GMP contract manufacturing of biopharmaceuticals, covering services from early development to finished vial.