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Expertise in microbial

A faster route to synthesis

Microbial technology is a specialized area driven by a number of different molecule formats requiring a variety of manufacturing process formats.

In general, microbial expression systems are most suitable for the synthesis of smaller and non-glycosylated proteins – larger proteins such as monoclonal antibodies require mammalian cell culture instead. A doubling time of minutes instead of hours means microorganisms based upstream processes are significantly (up to 30-fold) shorter than mammalian processes and yield high product titers up to 20 g/L.

A faster route to synthesis
Figure 1: Chemical and biopharmaceutical active pharmaceutical ingredients (APIs) differ in size and complexity. Microbial host cells are best suited for small biopharmaceuticals.

The numbers

Boehringer Ingelheim Vienna develops and manufactures a variety of molecule formats using microbial technologies. These include:

  • recombinant proteins (for example, growth hormones and peptides)
  • antibody-like molecules (for example, fragments and scaffold proteins)
  • sub-unit vaccines
  • virus-like particles
  • plasmid DNA

Our key manufacturing technologies are mainly E. coli and yeast systems.

We have a track record to trust, having derived more than 150 molecules in the past 40 years. Our combination of broad commercial expertise and development capabilities means we can offer the whole value chain from early stage to launch and commercial supplies. Our key in-house capabilities are outlined below.

Expertise in microbial
Figure 2: Our broad commercial expertise and development capabilities cover the whole value chain

Reliable and high-quality supplies

Our Vienna site operates three facilities, providing flexibility with cGMP scales in the range of 200 L up to 4,500 L working volume, designed for high cell density processes. All facilities are multi-licensed with a strong manufacturing track record of 20 commercial products for global markets.

Reliable and high-quality supplies
Table 1: Our fermentation capacity for microbial manufacturing.

Our downstream can handle a large variety of molecule formats, mainly manufactured in E.coli and yeast systems. The foundation is our strong capabilities in protein refolding as well as soluble expression and purification at large scale. For example, we have commercial scale columns up to 1.8 diameter and special techniques for difficult to manufacture proteins/peptides in explosion-proof facilities. Customers can benefit from chemical modifications that prolong the half-life of a protein of through, for example, PEGylation or Albuminfusion.

Industry leading timelines

Once a molecule format has been defined, we employ high-throughput platforms, including automation, to speed up time to initiation of clinical trials. With our SMART PROCESS DESIGN tool, we can convert data via machine learning or mechanistic process models to simulate and optimize manufacturing processes. This results in a prediction on how to set process parameters for optimal output. The outcome is a manufacturing process that delivers efficiency, quality and speed for desired molecules, both in clinical development and for market supplies.

Experts in Microbial Faster Delivery
Figure 3: Our general approach from lab to commercial scale for recombinant protein manufacturing.

An ideal partner in microbials

  • Proven technical expertise and in-house capabilities for diverse molecule formats, manufactured in E. coli and yeast systems.
  • A collaborative 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.

 

For more information, please read the full whitepaper here.   

For further information please contact Dr. Sandra Peinhopf or Dr. Barbara Esch