Extractables and leachables testing using a Quality Risk Management approach
17th October 2018 | 10 AM EST | Dhaval Tapiawala, Principal Scientist at Pfizer and Satish Kumar Mohanvelu, Life Sciences Management Professional at MilliporeSigma |WATCH FOR FREE
• Understanding extractables and leachables for better adoption of single use systems
• Ensuring safety of drug through determining the level of leachables throughout product life cycle
• Case Study of implementation of standardized testing protocol
Presented by Dhaval Tapiawala, Principal Scientist at Pfizer
Dhaval graduated from University of Pune, India with B.E. in Chemical engineering in 1997. He joined University of Louisville in 1998 and completed his M.S. in Chemical engineering in 2000. His research thesis was increasing single cell protein from distillery waste. He has over 18+ years of experience in biotech industry. He has worked in validation group doing process & equipment validation, engineering group to design, technology transfer and CMC filing of therapeutic, blood plasma and vaccine processes. He has both upstream & downstream experience in microbial and cell culture platforms. In 2016, he joined Pfizer as Principal Technology Scientist to design brown-field capital project to technical transfer of commercial vaccine production to Pfizer site. He has vast experience of designing & implementing single use system in mainstream manufacturing and actively involved in BPOG.
Sponsored by Merck
Merck is a life science leader that offers products and services used by pharma and biopharma companies to develop and manufacture drugs safely and efficiently. We provide excipients and APIs for all final dosage forms, complex API manufacturing services and critical raw materials to support all stages of the drug manufacturing process from research to industrial-scale production. Our Emprove® Program provides extensive regulatory documentation to facilitate risk assessment and qualification processes.
A Risk based approach towards Extractables Studies for Single Use Systems used in Biomanufacturing process
The adoption of single-use technologies in a biopharmaceutical process largely relies on confidently selecting the right components for use in the fluid path of a product, within a specific process. An important step in choosing such components requires generating an extractables profile, which can be done through carefully planned study strategies.
This webinar will focus on:
- A risk based approach while selecting Single Use components for Extractables studies.
- An insight into Industry standards in adopting an Extractables protocol at a baseline testing strategy.
Presented by Satish Kumar Mohanvelu, Life Sciences Management Professional at MilliporeSigma
Satish Kumar Mohanvelu is a Marketing Manager at Millipore Sigma, USA. In this role Satish is responsible for implementing the Emprove® Program with a specific focus on Filtration and Single Use Portfolio of Products. Through this program very comprehensive dossiers are created for the products to support customers globally with material qualification, risk assessment and process optimization initiatives. Extractables information is one of the key contents of the Emprove® Dossiers.
Satish is a PMP and a Post Graduate in Biochemistry with over 18 years of experience in the Biopharmaceutical Industry. Having spent 10 plus years within the organization, he has held various roles in supporting and promoting the validation services in the past. In this capacity he directly managed the Filter Validation Services and laboratories in India successfully for many years.