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Process Development

Focused process development studies with the aim of improving yields and product quality are beneficial in terms of time saved to clinic and project budget when planned correctly.

Time and effort spent on key areas of the process is critical when planning to produce material in larger quantities for later phase trials. Optimizing yields and productivity from upstream and downstream steps will lead to lower production costs and a faster route to commercial supply. A good process is characterized by reproducibility, robustness, high yields both in terms of process time and scale of manufacture (time-space yield) and quality, followed by transferability, scalability and affordable costs.

The processes we develop on behalf of our customers are GMP compliant.  We ensure that all materials and equipment are fit for purpose and can be used as the process moves forward for GMP manufacture. The process development stage is also important for establishing the relevant in-process controls and analytical tools required for release of the final product.  Vibalogics brings a wealth of experience in suggesting the most relevant assays to characterize your product whilst remaining relevant to the clinical stage of the project.

The following activities are performed at Vibalogics and are often considered as key areas for process development:

  • Conversion of conventional process to single-use technologies
  • Transfer process to defined media
  • Optimize feeding strategy
  • Elimination of media supplements such as anti-foam and animal based products
  • Optimization of filtration technologies and filtration train to reduce the number of steps and minimize costs

Vibalogics develops cGMP processes with the following aims in mind:

  • Quality
  • Productivity
  • Functionality
  • Robustness
  • Scalability
  • Transferability

For more information regarding Bacteria Process Development, contact us today on +49 4721 565 400 or email contact@vibalogics.com

Bacteria

Live bacterial products…

…aseptically manufactured