Boehringer Ingelheim Contract Development and Large-Scale Manufacturing of Biopharmaceuticals

Boehringer Ingelheim is one of the world’s leading companies for contract development and manufacturing of biopharmaceuticals. All types of services from mammalian cell line or microbial strain development to final drug production and global market supply can be delivered within a one-stop-shop concept.

Boehringer Ingelheim has brought 19 molecules to market and has many years of experience in multiple molecule classes such as monoclonal antibodies, recombinant proteins, interferons, enzymes, fusion molecules, novel scaffold proteins and plasmid DNA.

Large-scale biopharmaceuticals manufacturing

At its large-scale manufacturing sites in Biberach (Germany), Fremont (US) and Vienna (Austria), Boehringer Ingelheim manufactures biopharmaceutical products under cGMP for the global market and for all stages of development. The Biberach and Fremont sites are specialised in highly efficient mammalian cell culture systems while the Vienna site offers high-yield bacteria and yeast processes for clinical and market supply.

For the past 125 years Boehringer Ingelheim’s basic principles and claim have remained to be outstanding in innovation and technology. It is our endeavour to bring your groundbreaking discoveries to the market with ever-improving methods for biomanufacturing.

Experienced manufacturer of biopharmaceuticals under cGMP

Working with Boehringer Ingelheim brings a variety of benefits. A partnership with Boehringer Ingelheim enables both small and large-scale cGMP production in multi-product plants approved by the European, US and Canadian authorities. As an established privately owned and globally operating company, Boehringer Ingelheim is a reliable partner for regulatory agencies and can guarantee smooth registration proceedings. Regular audits by customers secure compliance with the latest standards and result in highest performance and good success rates.

Boehringer Ingelheim has broad expertise in multifarious biopharmaceutical customer projects and has experience in the shipment of cell lines, frozen and liquid bulk material and drug product, as well as vast knowledge in technology transfer and process adaptation.

The company’s contractual competence allows smooth and quick handling of all necessary agreements, and its reliable financial standing is important for long-term arrangements. Working with Boehringer Ingelheim enables accelerated entry to the market, portfolio and capacity enlargement, flexibility in project uptake supported by a global network of production partners, and many advantages thanks to the low costs of goods due to our balanced production programme.

Biopharmaceutical production sites

Our biopharmaceutical production sites have the following capabilities and capacities:

  • >200kl commercial capacity for cell culture
  • >12kl commercial capacity for microbials and yeast fermentation
  • Maximum scale: 12kl (cell culture), 4.5kl (microbials and yeast)
  • Pilot scale: up to 2kl (cell culture), up to 200l (microbials and yeast)
  • Fill and finish (vials, syringes, cartridges) for clinical and commercial supply

Contract development and manufacturing of biopharmaceuticals

We can offer you a wide range of services for the contract development and manufacturing of biopharmaceuticals. These include:

  • Process development from DNA to drug product
  • Feasibility studies (expression and purification)
  • Analytical method development
  • Technology development
  • Process characterisation
  • Process transfer and optimisation (in and out)
  • Production of material for toxicological studies and clinical studies
  • Troubleshooting
  • A track record of more than 150 successfully transferred projects

Regulatory track record in biopharmaceutical manufacturing

Our regulatory track record in the last ten years is excellent. We have successfully undergone in our multiproduct facilities more than 80 regulatory cGMP audits and pre-approval inspections (PAI) from the EMA, FDA, Health Canada, PDMA (Japan), tFDA (Taiwan), KFDA (Korea), GCC-DR (Gulf States), COFEPRIS (Mexico), ANVISA (Brazil), ISP (Chile), MOH (Kazakhstan), MOH (Russia), NDA (Uganda) and many regular customer inspections.

For approval of our customer biopharmaceuticals we support the regulatory documentation for the CMC section benefiting from our long-standing experience in IND, BLA and other regulatory filings.

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Press Release

Exclusive Cooperation Between ARTES and IPK

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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Boehringer Ingelheim

Binger Strasse 173

55216 Ingelheim am Rhein

Other

Germany

+49 6132 77 0 +49 6132 72 0 www.biopharma-cmo.com

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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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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

Boehringer Ingelheim

Binger Strasse 173

55216 Ingelheim am Rhein

Other

Germany

+49 6132 77 0 +49 6132 72 0 www.biopharma-cmo.com

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