Is India Anywhere Closer to Implementing Continuous Bioprocessing

16th August 2018 | 3.00 PM Indian Standard Time, 11.30 AM CEST, 9.30 AM GMT | Narasimha Rao Nedunuri, Managing Director of CLONZ and José Castillo, PhD, CTo and co-founder of Univercells |WATCH FOR FREE
Continuous processing has been widely employed in many biological manufacturing processes. In recent years it gained the momentum in the field of Biosimilar manufacturing due to an ever-increasing pressure for reduction in manufacturing costs. Potentially, the continuous processing offers Lower Cost of Goods, ease of scalability, and lower manufacturing footprint and hence became a topic of interest to many biosimilar players. Ongoing research on various new technologies for continuous operation, both in upstream and downstream processing may potentially be a game changer. Top on the wish list being, integration of all the multiple unit operations into a single continuous process with real time analytical tools. Though there are several challenges to develop and adapt continuous bioprocess, the magnitude of potential benefits are currently driving the research programs worldwide. India , being a significant global player in the biosimilar domain, currently making efforts to adapt these novel processes to make the drugs more cost effective.

Presented by Narasimha Rao Nedunuri, CEO of CLONZ Biotech

Narasimha Rao Nedunuri is one of the founding members of CLONZ Biotech, a Biosimilar Monoclonal Antibody company based in Genome Valley, Hyderabad, India.
He is currently serving the company as the Managing Director & CEO .
Nedunuri, a Molecular Biologist turned Entrepreneur has 18 years of experience in the field of Life Sciences Research including Cancer Biology, Proteomics, and Molecular diagnostics. He also had business experience in a USA based company, with the responsibility of establishing a business division for its Indian subsidiary.
At CLONZ , a 7 year old start-up, along with the co-promoters coming from recognized leaders who launched complex Biosimilar MAbs, driving the company to emerge as a significant Global Biosimilar MAb company.

Sponsored by

Univercells is a technology company offering novel biomanufacturing platforms, aimed at increasing the availability and affordability of biologics – recombinant proteins and vaccines – for all. Univercells designs innovative production processes to significantly decrease the size of the necessary equipment and facility, for a lower capital and operational cost.
The company’s process intensification and integration technology entails smaller footprint and unit cost while offering flexible capabilities, from small to large batches.
Deployment of affordable production units enables ‘in-country, for-country’ biologics production, creating value for manufacturers and healthcare systems with cost efficiency and local supply while increasing patients’ access to healthcare.
Univercells was founded in 2013 by experienced entrepreneurs Hugues Bultot, CEO, and José Castillo, CTO, who bring close to 25 years of expertise in the biotechnology and life sciences sectors. Headquartered in Gosselies (Belgium), Univercells benefits from support from the Walloon region, and received €3 million from Takeda in 2015. Most recently, the company was awarded a $12 million grant from the Bill & Melinda Gates Foundation.
Presented by José Castillo, PhD, CTo and co-founder of Univercells
After working as the head of viral vaccine industrialization at GSK Vaccines, he started up Artelis with a small group of developers in 2006. At Artelis, he designed and developed bioreactors that transformed industrial operations. With his team, he developed the iCellis system and transferred it for more than 50 viral processes over the world. The technology is now marketed by PALL, where Jose held the position of Director of Cell Culture Technologies. With the same group of developers, he started up Univercells in 2013, aiming to develop disruptive manufacturing platforms that significantly impact affordability to vaccines and antibodies.
With a background in Chemical Engineering, Jose’s education includes a PhD in Applied Sciences from the Université libre de Bruxelles, and an entrepreneurship degree from the Solvay Business School.​ As Univercells’ CTO, he is now the architect of highly efficient production processes that will make cell culture available and affordable for all. The goal is to disrupt the industry and become the leader of comprehensive manufacturing solutions.
Continuous Bioprocessing for cost-effective vaccine manufacturing
Vaccines are one of the most powerful and effective health interventions ever developed, providing tremendous economic and societal value. Yet a number of factors interact to limit complete global immunization coverage, as is the capacity to develop fast and effective vaccines and cost-effective vaccine production. Innovations are needed to develop manufacturing platforms able to transform production economics.
In this light, Univercells has developed an affordable, ultra-low footprint platform designed to produce up to 40M doses per year of sIPV vaccines. Intensified upstream and downstream operations are integrated into a continuous process, resulting in a drastic reduction of footprint and manufacturing cost. The use of automation and real-time parameters monitoring and adjustment permits to increase process robustness and reproducibility, reducing manual operation-related risks.
Based on innovative continuous processes, Univercells’ viral micro-facility leads to a tremendous impact on the factory design, CAPEX and cost of manufacturing, for a global increase of vaccines availability.

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