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Syngene Viral Testing Facility
Striving for ExcellenceDr Rahul S FadnisViral Testing Services, Syngene International Ltd.
2 | External Document © 2020 Syngene International Limited
Syngene International is a leading research, development and manufacturing services organisation engaged in a diversified range of domains including chemical development, biology, biologics, pharmaceuticals, agribiotech, nutraceuticals, to name a few.
The Company provides services to some 300 clients, including eight of the ten largest pharmaceutical companies who consider Syngene to be a strategic partner in their drug development programmes.
Biologics are a key driver of future biotech industry growth. The domain is expected to expand at 16-20% per year for next few years, with the upcoming patent expiration of some biologics therapies giving a shot in the arm to manufacturing services. Novel molecules for therapies targeting the oncology segment will also be a key growth driver.
The broadening of biologics development and manufacturing drives increasing demand for viral safety testing and clearance services. These tests are key to obtaining a successful application for clinical trials and commercial licensing of every biologics molecule. Biologics testing services are offered by only a handful of service providers globally and Syngene is proud to be among this group. It is the only provider from India to provide at-par services to biopharmaceutical companies since 2017.
Our facility is GLP-certified by the national GLP compliance monitoring authority from the Government of India, as per the OECD principles of GLP. This certifies our laboratory to be in line with the OECD rules covering countries such as the USA and Japan.
Over the past three years, the Syngene facility has grown from establishing a service capability to enabling virus clearance studies, bulk harvest and research cell bank testing. These services ensure the safety of the drug manufactured in mammalian cell systems like CHO.
Biologics manufacturers need to comply with the regulatory requirements associated with testing of cells expressing the therapeutic drug at cell bank stage, test harvested cells and undertake virus clearance studies for process manufacturing the drug.
The testing and clearance studies ensure that the therapeutic proteins (or drugs) are free of opportunistic pathogens, such as viruses, and assures the robustness of the process to remove viruses which may be introduced unintentionally into the manufacturing environment or process. The orthogonal approach (of testing and clearance evaluation) ensures that patients receive a safe drug.
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Quality Approach:Offering robust quality services with unrelenting customer focus is at the core of everything we do at Syngene. We have invested in the discovery and development and manufacturing phases of the drug pipeline to ensure that we have world class quality systems in place, in line with the global regulatory requirements. Our continuous improvement program includes internal audits and unannounced inspections in addition to client and regulator audits to ensure that quality standards are maintained constantly.
Client audits are an integral part of service delivery at Syngene. They help shape the system as per current regulatory demands. A dedicated team from quality assurance ensure that all studies are inspected in life, reports reviewed and audited before submitting them to clients.
Safety:Syngene’s inhouse safety programme – Kavach – ensures that every employee understands the organisation’s ethos and approach to safety. We put in place regular safety walkthroughs and conscious safety initiatives to ensure safety is at heart of everything we undertake personally and professionally.
The viral testing services are undertaken in a biosafety level -2 category laboratory. The facility complies with World Health Organisation (WHO) standards for biosafety to handle risk group 2 organisms (viruses and cell lines). The state-of-the-art facility is equipped with adequate controls of engineering and procedures to ensure the safety of people and environment.
Niche talent for niche service:Syngene’s talent acquisition receives the same attention as delivering quality service. Working in the niche area of viral testing, people with the necessary exposure, experience and skillsets are in a select pool. Employees are selected with an emphasis on scientific knowledge, skill set and work experiences. We offer on-the-job training, scientific lectures and external training to keep abreast with the latest industry trends.
The rewards and recognition program recognizes employee contributions for excellence in scientific research, on-time delivery of client projects, safety solutions, and leadership.
4 | External Document © 2020 Syngene International Limited
Service to Nation in COVID-19 Crisis:
Syngene has extended its support to the nation in its fight against the COVID-19 virus. The Viral Testing Laboratory, along with support from other teams, took the initiative to set up screening of COVID-19 patient samples for SARS-CoV-2 under its CSR program. The laboratory was accredited from NABL, Govt of India and ICMR (Indian Council of Medical Research) to do this work. Scientists, already in our workforce, and conversant with the special skills required to work with infectious samples in Biosafety and Security conditions, provided the impetus and confidence to take up this service initiative as quickly as possible.
Syngene also takes seriously the need to share its skills and experience. The team conducted an one-day workshop on Viral Safety on July 12th 2019 bringing together speakers from the industry, participants and vendors to discuss best practices in viral safety.
The Viral Testing lab at Syngene offers employees and potential employees a chance to experience cutting-edge research in a holistic environment. Syngene is on course to expand its services, given the growing clientele, and actively seeks new employees to join its family of over 5,000 members.
We invite any queries on our viral testing solutions or employment opportunities to be directed to [email protected]
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About the Author:
Dr Rahul S FadnisLead Investigator − Viral Testing Services
Experienced biotech professional in the area of Viral Safety, Clearance and Vaccine Development. His work focussed on conducting
viral clearance studies on the downstream manufacturing process for recombinant proteins, novel as well as biosimilars. In his
previous role, he holds experience of conducting the cell bank characterization studies on the mammalian cell banks expressing
therapeutic recombinant proteins. Actively involved in development of viral assays for in-vitro and molecular based platforms
for detection of retro and adventitious viruses from recombinant protein products expressed in mammalian systems. He has
been instrumental in development of sensitive assays for detection of residual DNA from protein product intermediates of a
manufacturing process. Rahul has several publications in peer reviewed journals and patent to his name. Played active role in GLP
certification of the First Viral Testing Lab in India.
Roles and responsibilities: Heading of Viral Testing Facility. Responsible for execution of client projects for Viral Clearance and
bulk harvest testing.
Education: PhD. Microbiology (Virology)
© 2020 Syngene International Limited, Bengaluru, India. All Rights Reserved. Syngene believes the information in this document is accurate as of its publication date; such information is subject to change without notice. Syngene acknowledges the proprietary rights of other companies to the trademarks, product names and such other intellectual property rights mentioned in this document. Except as expressly permitted, neither this documentation nor any part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, printing, photocopying, recording or otherwise, without the prior permission of Syngene International Limited and/ or any named intellectual property rights holders under this document.
For more information, contact [email protected]
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