Global mammalian cell culture biologics expertise

As your trusted CMO partner, Boehringer Ingelheim BioXcellence™ delivers reliable, scalable and high-quality mammalian cell culture manufacturing, from late-stage clinical to global commercial supply.

Your mammalian manufacturing partner

In the rapidly evolving market of biopharmaceuticals, monoclonal antibodies derived from mammalian cell culture account for approximately half of all produced biologics.

Boehringer Ingelheim BioXcellence™’s mammalian manufacturing expertise is not only limited to this dominating molecule format; instead, we’re able to produce a wide range of mammalian‑derived biologics at late-stage clinical and commercial scale.

We manufacture mammalian biopharmaceuticals such as monoclonal antibodies, fusion proteins, complex antibodies, enzymes and other recombinant proteins in a global manufacturing network spread across the USA, Asia and Europe.

We're proud to be one of the leaders in this key technology, with a 40+ years’ history of success that includes 29 mammalian-derived market products.

Our mammalian contract manufacturing capabilities

Looking back at decades of experience, we’re known for our upstream, downstream, and aseptic filling know-how, robust tech transfers, effective launch preparation and regulatory support.

We build quality and reliability into every stage of our mammalian manufacturing operations, and all sites operate under harmonized global quality systems. With all analytical capabilities available in‑house, incl. full GMP batch release testing, we maintain control over product quality and timelines.

We’re your one-stop partner for mammalian drug substance and drug product.

Mammalian manufacturing services

• ~ 460,000 L overall commercial production capacity in a worldwide manufacturing network

• CHO‑based mammalian cell culture

• Fast and tailored tech transfers in ~ 12 months

• Upstream and downstream processing

• N-1 perfusion technology

• Late-stage clinical and commercial supply

• GMP batch release testing from multi-licensed facilities

• Launch preparation, submission and regulatory support

• Logistics support in material and vessel management

In-house analytical services

• Bioassays and ELISA

• Microbiology

• Raw materials lab, raw material qualification and testing

• TOC lab

• DNA lab

• Electrophoresis

• Chromatography

• IPC support, determining product quality

Aseptic filling services

• 25+ years of aseptic filling experience

• Flexible filling volumes for late-stage clinical and commercial supply

• Formulations for liquid and lyophilized vials

• Manual and automated visual inspections

• Explore our aseptic filling services in more detail

Global cGMP network for mammalian cell culture manufacturing

Our mammalian cell culture production network spans three continents, demonstrating our commitment to being your global CMO partner. The multi‑site network gives partners flexible manufacturing paths, optimized lead times, and reliable delivery across the world.

With about 460,000 L of commercial mammalian drug substance production capacity distributed between the USA (Fremont, California), Germany (Biberach), Austria (Vienna) and China (Shanghai), we’re committed to high-quality late-stage clinical and commercial supply.

• Fremont, USA: Strategic U.S. site offering two separate trains for mammalian cell culture production.

• Biberach, Germany: Flagship large‑scale hub with deep process expertise and robust commercial scale‑up capability.

• Vienna, Austria: Newest cell culture production facility with high level of automation and digitalization to maximize output.

• Shanghai, China: Regional hub providing flexible supply routes and accelerated access to Asian markets.

All our cGMP multi-product facilities are licensed by the EMA, FDA, MHLW, and others.

Similarly, N-1 perfusion technology is implemented throughout our mammalian manufacturing network to accelerate late‑stage and commercial biologics programs.

Get a glimpse at our expertise by watching the video below showcasing our multi-product large-scale cell culture facility in Vienna.

Large-scale cell culture facility in Vienna – Boehringer Ingelheim BioXcellence™ from Boehringer Ingelheim on Vimeo

Cross-site synergies in our large-scale production network

Our large-scale mammalian manufacturing network is spread over three continents, with commercial capacity up to 18kL.

The similar setup of bioreactors and harmonized procedures means flexibility and supply security for partners.

Whether in the U.S., Germany, or Austria, we offer site-neutral product supply. Seamless operations across sites ensure consistent quality and delivery.

Together, let’s navigate changing product demands, regulatory or geopolitical complexity. Our team of mammalian manufacturing experts is ready to solve your next challenge.

“I enjoy working closely with our customers to understand their needs and transform them into robust, scalable processes. Together, we ensure that each product reaches patients with the highest quality.”

“For me, MSAT is about curiosity and collaboration. We test, learn, adjust – and together we aim to make sure that our biologics run exactly as they should.”

What we manufacture at Boehringer Ingelheim BioXcellence™

In mammalian manufacturing, we’re experienced in various molecule formats, including:

• Monoclonal antibodies

• Complex antibodies, such as bi-specific or multi-specific antibodies

• Fab fragments

• Fc Fusion proteins

• Ig DART

• Recombinant proteins and enzymes

Why partner with Boehringer Ingelheim BioXcellence™?

The last 40 years are a testament for our long-standing and in-depth experience in the manufacturing of biopharmaceuticals. As pioneers in mammalian cell culture technology, we’re proud of a product track record of 29 mammalian-derived market products.

With services from launch to commercial supply, we’re your end-to-end partner for mammalian drug substance and drug product.

Our track record in mammalian biomanufacturing:

• 40+ years of mammalian manufacturing expertise

• 29 marketed products manufactured in mammalian cell culture systems

• Vast experience with about 80 different mammalian manufacturing processes

• Robust and tailored tech transfers (~ 12 months) with rapid onboarding of client processes into our manufacturing facilities

• End‑to‑end manufacturing capabilities, in-house analytical methods, launch preparation and regulatory support

• Advanced digital tools (e.g. digital twin, artificial intelligence) for fast transfers and process optimization

• Large‑scale commercial manufacturing capacity for mammalian cell culture biologics

We’re an ideal, long‑term contract manufacturing partner in mammalian cell culture technologies.

Our integrated capabilities span upstream and downstream manufacturing, aseptic filling, launch preparation, and regulatory support, enabling a seamless transition from drug substance to drug product within a single global network.

Our unique partnership approach and commitment is also reflected in the voices of partners who have worked with us.

“We deeply value the continuous communication and collaboration that have characterized our partnership despite facing numerous hurdles along the way.”

Mammalian cell culture thought leadership

We're proud to be pioneers in the mammalian biopharmaceuticals space. Look at our featured content below to learn more about our history and expertise.