Boehringer Ingelheim

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.