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
- 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.
Products and Services
Boehringer Ingelheim Wins 2011 European Bio Pharmaceutical Contract Manufacturing Competitive Strategy Leadership Award
Boehringer Ingelheim is pleased to announce that it has received the Frost & Sullivan '2011 European Bio Pharmaceutical Contract Manufacturing Competitive Strategy Leadership Award'. The analysts recognised Boehringer Ingelheim Biopharmaceuticals as a global contract manufacturer tRead more
Boehringer Ingelheim and ProBioGen have signed a non-exclusive licensing agreement regarding ProBioGen's GlymaxX® technology. Boehringer Ingelheim's Contract Manufacturing Business will apply the technology to enhance ADCC (antibody-dependent cell-mediated cytotoxicity) activity of antibodieRead more
Boehringer Ingelheim is expanding its capacities and capabilities in fill and finish for biopharmaceuticals at its state-of-the-art facility in Biberach, Germany, with a new filling line. The new line is available as of today for contract filling of liquid and lyo vials from 0.5ml - 100ml. The exRead more
Boehringer Ingelheim is pleased to announce the US-registration for manufacturing of Bayer HealthCare's Betaferon® against multiple sclerosis. Recently Bayer HealthCare has extended the commercial production agreement for Betaferon with Boehringer Ingelheim, which received the FDA approval fRead more
Pfenex, an industry leader in protein expression through the Pfenex Expression Technology platform, and Boehringer Ingelheim International, a leading pharmaceutical company and global leader in biopharmaceutical contract development and manufacture, announced today that thRead more
Boehringer Ingelheim Collaborates with VTU Technology to Provide Customers with a Broader Range of Contract Services
Boehringer Ingelheim, a global leader in biopharmaceutical contract development and manufacture, and VTU Technology, a leading supplier of exclusive technologies and comprehensive services for the development of high-performance Pichia pastoris protein expression strains, have entered into a globRead more