Expertise and excellence in a thriving sector
Microbial product market is a market with attractive growth – and that growth is coming from diverse molecule formats and process formats where Boehringer Ingelheim in Vienna has outstanding development and manufacturing experience. We’re proud to be pioneers in the microbial field, with a track record of success going back to the 1980s and our work on recombinant interferons. Since then, we have brought 20 microbial manufactured products to the global market: some our own, some as trusted manufacturing partner.
Why microbial?
Microbial systems are ideal for synthesizing smaller and non-glycosylated proteins, complementing mammalian cell processes for larger proteins like monoclonal antibodies. With doubling times measured in minutes, not hours, microbial upstream processes can be 30 times faster than mammalian processes and yield product titers as high as 20 g/L of fermenation broth.
It’s also a versatile technology that allows for production of a wide and diverse range of molecule formats. Our Vienna facility has experience of delivering recombinant proteins like growth hormones and peptides, as well as antibody-like molecules (e.g., fragments, scaffold proteins), sub-unit vaccines, virus like particles, and pDNA (plasmid DNA) products.
Our cGMP facilities - quality and reliability
Boehringer Ingelheim comprises three facilities in Vienna, allowing flexibility on cGMP scales from 200 L up to 4,500 L working volume - designed for high cell density processes. All three are multi-licensed, with a strong track record of manufacturing for global markets. Our downstream can handle a great variety of molecule formats, mostly using E. coli and yeast systems.
At the heart of our success in Vienna lies our strong capabilities in protein refolding, as well as large scale soluble expression and purification. We have commercial scale columns up to 1.8 m in diameter, plus special techniques (e.g. handling organic solvents, large scale HPLC columns, bulk lyophilization) and explosion-proof facilities for hard-to-manufacture proteins and peptides. We also offer chemical modifications to prolong protein half-life, including PEGylation and albuminfusion. All this combines to yield consistently, reliably high-quality output.
Advanced technology for faster delivery
Once the molecule format has been defined, our highly automated, high-throughput platforms can shorten time to clinical trial. Our SMART PROCESS DESIGN tool uses machine learning or mechanistic process models to simulate and optimize manufacturing processes, helping us to predict the right process parameters for optimal output.
Our CASPONTM fusion protein system, for non-platform molecules, includes a peptide fused to the N-terminus of the protein of interest and a highly specific protease to remove the tag after purification, leaving the authentic N-terminus of the target protein. This increases product yield (up to tenfold depending on the target molecule), enhances product solubility (preventing IB formation), provides a recognition sequence for the protease, and includes a histidine stretch for a platform affinity purification.
Combined with a comprehensive genetic toolbox and predictive screening, our advanced and improved manufacturing processes bring real benefits to all our customers - whether they need clinical development or market supply, and whatever their desired molecules.
An ideal partner
In the last 40 years, those processes have yielded over 150 molecules – and long-standing, in-depth experience of both development and manufacturing of biopharmaceuticals.
Blending that experience with our broad commercial expertise, our development capabilities, and our state-of -the-art facilities, we can offer the whole value chain: from early stage, to launch, to commercial supply.
In short, we are the ideal partner in microbials.
Proven technical expertise and in house capabilities for diverse molecule formats manufactured in E. coli and yeast systems.
Collaboration partner for sustainable late stage and commercial manufacturing from our microbial facilities.
Long-standing experience with a track record of 20 microbial commercial products brought to the market together with our partners.
Microbial capabilities reflect global market: 300 L and 2 x 6,000 L for commercial microbial manufacturing.
Digital Twin and Artificial Intelligence for fast transfers and process optimization.
We have all analytical methods in-house: Microbiology, Cell & Molecular Biology, Raw Material Testing, TOC & Photometry, Chromatography and Virology.