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Fully continuous biosimilar manufacturing framework: A case study

Biologics manufacturing has traditionally been in fed batch mode for the last 2 decades. During the early stages of biologics manufacturing, lower cell line productivity and product instability necessitated the usage of perfusion technology. As productivity increased and mabs became more stable, perfusion was replaced by fedbatch technology, as they were simpler to scale up. However, during the past 2-3 years, the perfusion technology is making a comeback due to the novel continuous chromatography technology. Connecting the perfusion bioreactor to the continuous chromatography system creates a continuous flow of drug substance and promises the following advantages

The facility footprint for a continuous manufacturing plant would be substantially lower. Our calculations show that a 10-fold reduction in bioreactor size is possible with continuous bioprocessing. So the capacity of a 2000L Fed batch Bioreactor can be achieved by a 200L continuous bioreactor. This reduces the capex by about five fold.
Consumption of media per amount of DS produced is the same for fedbatch and perfusion, although the cost per liter might be lower for perfusion as it could be a more diluted version of the fedbatch media ,
Another major cost in bioprocessing is the Protein A resin. A significantly smaller Protein A column could be used in the continuous process and the utilization could be maximized by this strategy.
As the process is more dynamic in continuous, automation and in-line analytical tools are essential for the successful implementation.
Enzene Biosciences is on the forefront of the development of the continuous bioprocessing. We are in the processing of building a cGMP plant that would have a fully integrated continuous bioprocess. We have already complete a proof of concept studies in pilot scale (50L)
Recorded Jun 14 2018 68 mins
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Presented by
Samir Varma, Head of Manufacturing, Enzene Biosciences and Lotta Molander, Global Product Manager, GE Healthcare
Presentation preview: Fully continuous biosimilar manufacturing framework: A case study
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    Compare and contrast the available full scale processing technologies, and discover what works the best for manufacturing next generation therapeutic products in Asia.

    Biologics are complex and hard to make, which helps to explain why biotech manufacturing plants are huge and expensive to build. To be competitive, manufacturing must be efficient and cost-effective and should brainstorm economical ways to manufacture biologics.

    Biosimilars are a cost competitive market. Pricing may have a direct impact on market share, and return on investment. The market for biologics, including approved and in pipeline like ADCs, antibodies & antibody fragments present both tremendous opportunity and challenge. Challenges necessitates looking beyond the current platform philosophy for how to modify the process with a goal to increase overall productivity in a flexible manner.

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    Cost Effective Biosimilars Manufacturing may include
    Single-use technologies and continuous upstream processes have proven to be cost-efficient options
    Aspects of continuous manufacturing in both upstream and downstream manufacturing are being incorporated thereby increasing yields through a combination of longer production run times, more stable and higher secreting cell lines
    Technologies enabling high productivity, right-sized, small footprint, continuous, and automated operations are being evaluated.
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    Partnerships will continue to transform biosimilars industry. In order to gain access to developed markets, Indian biosimilar manufacturers are partnering with multiple local established manufacturers and big pharmaceutical companies
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  • Title: Fully continuous biosimilar manufacturing framework: A case study
  • Live at: Jun 14 2018 8:30 am
  • Presented by: Samir Varma, Head of Manufacturing, Enzene Biosciences and Lotta Molander, Global Product Manager, GE Healthcare
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