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Mathematical Modelling for Microbial Bioprocess Design

Highlights

  • Fast and efficient design and optimization of microbial fed-batch process
  • Innovative, proven methodology based on a reference model database
  • Scale-ability is ensured using reference scale-up models
  • Complementary to DoE based bioprocess optimizations

Benefits

  • Increase productivity while meeting product quality specifications
  • Decrease risk of scale-up by implementing a robust feeding strategy
  • Decrease experimental effort based on a reference model database

The Exputec Service “Design and optimization of fed-batch processes: Feeding strategy” is applicable for following product categories and production systems:

Product categories, production systems and process steps

  • Biologics produced in microbial production systems
    • recombinant proteins
    • antibody fragments
    • pDNA, growth factors
  • Seed train & main fermentation process
  • Stainless steel and single-use processing

As a biotech company with a promising product pipeline, you are faced with the challenge of increasing productivity and to develop a scale-able fermentation process. As a product owner and innovator, you are responsible for the development of a manufacturing process that delivers a product that guarantees safety, efficacy and quality. Furthermore, you want to keep cost-of-goods low and increase the volumetric productivity. This will enable you to enter clinical phase 1 or phase 2 and market a competitive product.

In state-of-the-art fed-batch fermentation processes, the feeding strategy stirs productivity and product quality and impurity patterns of your manufacturing process. Furthermore, the feeding strategy is critical for scale-ability and technology transfer and subsequent downstream processing. Therefore, the challenge of feeding profile design is a key- and far-reaching challenge within the bioprocess lifecycle.

Design and optimization of fed-batch processes: Feeding strategy

With The Exputec Service “Design and optimization of fed-batch processes: Physiological feeding strategy”, Exputec has developed a unique service addressing the needs of biotech companies to optimize microbial production processes and ensure scale-ability. The service delivers an optimized fed-batch feeding strategy that enables high titers and which is fit for robust scale-up and technology transfer to a GMP production environment. Based on the Exputec model library and standard bioprocess data (optical density data, product data), the service optimizes microbial processes for the production of in stainless steel or single use production bioreactors. This increases productivity while decreasing costs of goods and ensuring robust scale-up to a state of the art cGMP production environment. This is done by a team of biopharma process experts, in close collaboration with your product –and process experts.

Streamlined project workflow

The Exputec Service “Design and optimization of fed-batch processes: Physiological feeding strategy” follows a clear and proven project workflow: First, confidentiality agreements are signed. Then, Exputec biotech experts analyze the “As-Is State” of the laboratory scale bioprocess and process design rationales. This is achieved in a streamlined workshop in close collaboration with the product or process experts at your company. Subsequently, Exputec data scientists structure and analyze available process- and product data. This data is used for the subsequent model building based on the Exputec model library. The developed model is presented in a customer workshop and applied for scale-up simulations and the in-silico design of an optimized feeding strategy. In the final project phase, Exputec consultants deliver and implement the optimal feeding profiles in your production environment and support you during the experimental verification of the results.

Comprehensive deliverables

Project results are post-processed by Exputec based on reference best practices. All optimization results, the applied scale-up and process design rationales are described in a comprehensive report. Within two month of overall project duration, comprehensive deliverables are provided to you that can directly be put to practice:

  • Optimized & implemented feeding profile to increase productivity
  • Report on scale-up and feeding strategy design rationales
  • Roadmap for scale-up and technology transfer

Project phases

1. Start phase
  • Confidentiality agreement
  • On-site workshop on process design
  • Transfer of data for model development
2. Prediction
  • Prediction of optimal feeding profile
  • Scale-up cross-check
  • Implementation concept
3. Verification
  • Support for experimental verification at customer
  • Data analysis of results
  • Comprehensive report