Biovian Contract Manufacturing Of Biopharmaceuticals

Biovian GMP contract manufacturing

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 antigen isolation, cell line and process development, cell cultivation, protein purification, and product’s fill and finish. Biovian’s GMP facilities are Europeans Medicines Agency (EMA) and Food and Drug Administration (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 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.

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 optimisation.

Cultivation

Biovian’s technologies for cultivation are conventional stirred-tank bioreactors and disposable suspension cultivation systems.

Hosts

The company offers 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 offers formulation development for biopharmaceuticals, stability studies, and end products and intermediates.

Analytical methods and quality control (QC) analysis

  • Immunoassays
  • 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
  • Endotoxin
  • Sterility
  • Total organic carbon (TOC)
  • Bioburden
  • Mycoplasma
  • Microbial challenge tests

Contract research and development

Biovian’s contract research and development services include expression vector construction and cell line development, cell cultivation, 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 facilities

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 2,700m² 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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Press Release

Meet Biovian at BioTrinity 2013 – European Biopartnering and Investment Conference – 14-16 May 2013, Newbury, UK

Meet Biovian at BioTrinity 2013 - European Biopartnering and Investment Conference - 14-16 May 2013, Newbury, UK.

White Papers

From Gene to Finished Vial

Biovian is a one-stop-shop in GMP contract manufacturing of biopharmaceuticals, covering services from early development to finished vial.

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Press Release

19 October 2016

Biovian has announced it will be present at the biotechnology partnering Conference Bio-Europe in Cologne, Germany.

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8 September 2016

Biovian will be present at Nordic Life Science Days, BioTalk, and Bio-Europe.

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9 March 2015

Biovian will attend BIO-Europe Spring 2015 from 9-11 March 2015 in Paris, France.

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8 June 2014

Visitors to this month's Biotech Outsourcing Strategies cmc 2014 in Copenhagen will have the opportunity to meet representatives from Biovian.

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6 March 2014

Biovian CEO Dr Knut Ringbom will be available for in-depth discussions with delegates at the forthcoming BIO-Europe Spring conference.

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10 October 2013

Biovian's CEO, Dr Knut Ringbom will be available for in-depth discussions with your delegates at the partnering offered at the conference, as well as at Biovian's stand D2, at Nordic Life Science Days.

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29 August 2013

Meet Biovian at BioKorea 2013 International Convention, 11-13 September at Kintex, South Korea.

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3 June 2013

Meet Biovian at Biotech Outsourcing Strategies cmc 2013, June 13, 2013, Copenhagen, Denmark.

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28 May 2013

Meet Biovian at Lyckad Läkemedelsutveckling, 30 May, 2013, Grand Hôtel, Stockholm, Sweden.

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15 May 2013

Meet Biovian at BioTrinity 2013 - European Biopartnering and Investment Conference - 14-16 May 2013, Newbury, UK.

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8 May 2012

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.

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8 May 2012

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.

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17 October 2011

Meet Biovian at the BioEurope 2011 partnering conference, which will be held 31 October - 2 November 2011

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2 October 2011

Meet Biovian at the ICSE-BioPh International Contract Services Expo, which will take place 25-27 October 2011 in Frankfurt, Germany.

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8 March 2011

Fujifilm Corporation and Merck, known as MSD outside the US and Canada, have announced that they have entered into a definitive agreement by which Fujifilm will acquire the Merck BioManufacturing Network, a leading provider of contract manufacturing and development services for the biopharmaceut

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26 September 2010

ARTES Biotechnology announces today the acquirement of the ANAVAX virus-like particle (VLP) technology from Select Vaccines. ANAVAX is a patent-protected VLP technology that can be applied to the prevention of several infectious diseases. With the combination of two excellent technolog

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2 June 2010

Bachem and ISA Pharmaceuticals have announced the conclusion of an agreement for the manufacture of the active ingredients and the supply of finished dosage forms of ISA Pharmaceutical's immunotherapeutic HPV-SLP® product. The company has successfully concluded a clinical phase II

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21 April 2010

The complex formation between biotin and avidin or streptavidin is one of the strongest and most specific non-covalent interactions of a low-molecular weight compound with a protein. In practical use, the non-glycosylated streptavidin is preferred over the glycoprotein avidin as it shows less uns

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23 March 2010

Bachem is continuously expanding and updating its extensive range of products for your research purposes. We are pleased to present our latest product additions, which include the PAC1 receptor antagonist M65, the opioid peptide Gliadorphin-7, additional pseudoprolines, and several high-sensitivi

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18 March 2010

In 2009, despite difficult market conditions, the Bachem Group achieved sales of CHF181.8 million. Compared with the previous year, this corresponds to a sales decline of only 5.6% in local currencies. The mid-year deficit compared with the previous year’s period was therefore substantially

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10 February 2010

Bachem, the number one in the production of peptides at any scale, is and will remain your ideal partner for custom synthesis. Our proficient peptide synthesis techniques coupled with high capacity and efficient production equipment result in swift delivery and superior quality. Our de

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16 November 2009

ARTES Biotechnology, specialised in recombinant protein production and process development from yeast expression systems, and Rhein Minapharm Biogenetics, a subsidiary of Minapharm SAE, jointly announced the successful production of a new target of a therapeutic protein. This was the first result

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18 October 2009

The coupling reaction is the critical step in peptide synthesis. In particular, the solid-phase approach relies on rapid peptide bond formation and complete conversion with a minimum of concomitant side-reactions such as racemization. To meet these requirements a plethora of coupling (

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18 October 2009

mondoBIOTECH and Bachem have announced the conclusion of a longterm cooperation. In the frame of the agreement with Interferon Medical Use in Collina d'Oro, Switzerland - a 100% affiliate of mondoBIOTECH Holding - Bachem provides its comprehensive know-how on peptides and its longstanding exp

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22 September 2009

Bachem is continuously expanding and updating its extensive range of products for your research purposes. We are pleased to present our latest product additions, which include a number of bioactive molecules, synthetic RANTES peptides, several LHRH impurities and a range of new immunology product

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1 September 2009

ARTES Biotechnology has announced its collaboration with five other collaboration partners in a joint 28-month research programme that is granted by the national Deutsche Stiftung Umwelt within the ChemBioTec initiative. The Deutsche Bundesstiftung Umwelt DBU is one of Europe's largest foundation

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5 August 2009

ARTES has announced that it has signed an exclusive marketing agreement with the Institute of Cell Biology of the National Academy of Science of Ukraine. The agreement is that the NAS technology based on the yeast organism Hansenula polymorpha is now exclusively marketed and licensed by ARTES Bio

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10 May 2009

ARTES Biotechnology has announced its collaboration with Henkel in a joint three-year research programme that is granted by the German national BMBF (German Ministery of Education and Research) within the CLIB2021 cluster (Wettbewerb Industrielle Biotechnologie 2021). The cooperation aims to adva

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14 January 2008

ARTES Biotechnology, which specializes in recombinant protein production from yeast expression systems, and Rhein Minapharm Biogenetics, a subsidiary of Minapharm, jointly announced the start of a strategic collaboration to develop three therapeutic proteins. Financial details were not disclosed.

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8 October 2007

ARTES Biotechnology GmbH expands technology platform Having achieved notable success with the Hansenula technology for years, the biotech company ARTES has now concluded an exclusive partnership with the internationally renowned Leibniz Institute of Plant Genetics and Crop Plant

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17 July 2007

"We are looking forward to working with an international team“, says Dr Melanie Dröttboom, head of business development of Artes Biotechnology GmbH. Biotech company Artes, based near Düsseldorf, has been confirmed that it is developing an aptamer-based microarray for

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29 May 2007

ACE Pharmaceuticals today announced that the first patient has entered the Phase III trial also known as the Levamisole trial. This trial was accepted by the EMEA by November 2006. The goal of this trial, which was accepted by the EMEA in November 2006, is to assess the efficacy and sa

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9 January 2007

ARTES announces the grant of the European patent on increasing recombinant protein secretion in yeast by co-expression of Calnexin, a protein responsible in intracellular quality control and sorting. In extensive studies, ARTES could show that overexpression of Calnexin results in sign

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19 June 2006

Kiel - Erkrath, June 19, 2006. PROTEO Biotech AG, a wholly owned subsidiary of PROTEO Inc., USA, has signed a cooperation agreement with ARTES Biotechnology GmbH. The aim of the agreement is the marketing of Elafin, the lead product of PROTEO Biotech AG / PROTEO Inc., in India, Egypt and Argentin

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Regional Offices

Biovian Ltd

Tykistökatu 6B, Biocity

FIN-20520 Turku

Other

Finland

+358 2 2748840 +358 2 2748841

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