Fully continuous biosimilar manufacturing framework: A case study


14th June 2018 | 9:30AM GMT, 2PM IST | Samir Varma, Head of Manufacturing, Enzene Biosciences and Lotta Molander, Global Product Manager, GE Healthcare |WATCH THIS FREE ON DEMAND WEBINAR

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

  1. 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.
  2. 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 ,
  3. 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.
  4. 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)

 

Presented by Samir Varma, Head of Manufacturing, Enzene Biosciences

Samir has more than 16 years of experience in the Biotech Industry. Having worked at various mid-size biotech and large pharma such as Medarex, Bristol Myers Squibb, Celgene in NJ, USA and Lupin Ltd and Enzene Biosciences in India, he has extensive experience in all aspects of process development and cGMP production of therapeutic biologics. Samir holds a MS in Biochemical Engineering from Drexel University, Philadelphia and a MBA from New York University, New York. He currently heads the Manufacturing Department at Enzene Biosciences. Enzene Biosciences is a full owned subsidiary of Alkem Laboratories and is based in Pune, India.

 

 

Sponsored by GE Healthcare

About GE Healthcare Life Sciences
The Life Sciences business of GE Healthcare provides a wide range of bioprocessing products and services that enable the development and manufacture of high-quality biotherapeutics and vaccines. Using our knowledge and expertise, we support our customers in increasing speed to market, while avoiding unnecessary costs and improving quality and performance in drug manufacturing.  As a provider of high-quality products, customized technical and commercial services, as well as design and construction of complete biomanufacturing solutions, we support the biopharmaceutical industry in making health visions a reality.

 

Continuous bioprocessing – one tool in the toolbox

The cost pressure on biopharmaceuticals drives the industry towards exploring process intensification options that will maintain or improve quality, stability, and manufacturability of the product. As one option in the process intensification efforts, continuous or connected biomanufacturing is being evaluated. For continuous chromatography, the interest in techniques such as periodic counter-current chromatography (PCC) is increasing with drivers such as operational flexibility due to reduced footprint and manpower, cost benefit for the protein A mAb capture step, and enhanced productivity.

This presentation will focus on process economy, and case studies of PCC setups will be discussed. In addition, process development and solutions for pilot-and large-scale manufacturing will be demonstrated. The novel MabSelect™ PrismA protein A resin provides upgraded features in terms of increased capacity and enhanced alkaline stability over predecessor products. Using this new resin in a PCC setup enabled improved productivity and allowed the use of high concentrations of NaOH for cleaning, thereby reducing the risk of column contamination during the extended PCC runs.

 

Presented by Lotta Molander, Global Product Manager, GE Healthcare

Lotta Molander is the Global Product Manager covering GE Healthcare’s continuous chromatography portfolio. With a background in Chemical Engineering she joined GEHC Life Sciences in 2006 spending the first 10 years as Section Manager and Department Director within R&D, supporting developmental projects for AxiChrom™ columns and ÄKTA™ lab scale systems, before joining the Product Management team in 2015.


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