Biovian Contract Manufacturing Of Biopharmaceuticals
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.
Products and Services
Rubraca (rucaparib) for the Treatment of Advanced Ovarian Cancer
Xultophy 100/3.6 for the Treatment of Type 2 Diabetes
SUN-101/eFlow for the Treatment of Chronic Obstructive Pulmonary Disease
Solithera (solithromycin) for the Treatment of Community-Acquired Bacterial Pneumonia
Xiidra (lifitegrast ophthalmic solution) for the Treatment of Dry Eye Disease
Briviact (brivaracetam) For the Treatment of Partial Onset Seizures
Biovian will be present at Nordic Life Science Days, BioTalk, and Bio-Europe.Read more
Visitors to this month's Biotech Outsourcing Strategies cmc 2014 in Copenhagen will have the opportunity to meet representatives from Biovian.Read more
Meet Biovian at Biotech Outsourcing Strategies cmc 2013, June 13, 2013, Copenhagen, Denmark.Read more
Meet Biovian at Lyckad Läkemedelsutveckling, 30 May, 2013, Grand Hôtel, Stockholm, Sweden.Read more
Meet Biovian at BioTrinity 2013 – European Biopartnering and Investment Conference – 14-16 May 2013, Newbury, UK
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Meet Biovian at the Biotech Outsourcing Strategies cmc2012 (BOS cmc) on 14 June 2012 at the Sohuset Conference Center, Denmark. Biovian's director of business development and projects, Dr Knut Ringbom, will be available for in-depth discussions with delegates at the conference.Read more
Meet Biovian at 'Lyckad Läkemedelsutveckling' seminar on 31 May 2012 at Hotel Grand, Stockholm, Sweden. Biovian's director of business development and projects, Dr Knut Ringbom will be available for in-depth discussions with delegates at Biovian's stand.Read more
Meet Biovian at the BioEurope 2011 partnering conference, which will be held 31 October - 2 November 2011Read more
Meet Biovian at the ICSE-BioPh International Contract Services Expo, which will take place 25-27 October 2011 in Frankfurt, Germany.Read more
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