Do Extractable Protocols Truly Help – An End User Perspective
08th May 2019 | 10.00 am EST | Ekta Mahajan, Genentech/Roche |BOOK FREE SEAT
Single Use technology is being used more each year in the biotechnology industry. However, extractables and their potential impact on product and patients continue to be one of the biggest challenges. The challenge is augmented by the lack of standardized methodology for suppliers to execute extractable studies that meets end-user requirements. The end users are responsible and required by law to assess the impact of extractables and leachables on overall Product Quality and Safety. Due to lack of a standard, customized data had to be generated for/by each end users. This resulted in long lead times, higher costs and inefficient utilization of resources. Typically, the data generation and qualification of single use component can take up to a year, which can impact implementation of single use. BioPhorum Operations Group (BPOG) developed a standardized protocol for generating extractable data that would meet user requirements and simplify/reduce implementation time within industry. A standardized protocol gives confidence to suppliers that testing performed by them would meet end-user requirements and enable faster implementation. Some suppliers shared the BPOG vision and proactively tested their single-use components using BPOG protocol, which has helped expedite the use of their products.
Presented by Ekta Mahajan, Technical Regulatory Program Director at Genentech
Ekta Mahajan is a Principal Engineer in Pharmaceutical Technical Development Engineering group at Genentech/Roche in South San Francisco, CA. In her fourteen years of research and manufacturing
experience in biotechnology, vaccines and pharmaceuticals, she has lead projects in a wide range of areas, both upstream and downstream, including commercial manufacturing support, process development, and new technology evaluations. Ekta has expertise in disposable technology and is currently leading projects for design and implementation of disposables in development and manufacturing including drug conjugates. She is an active member of BioPhorum Operations disposables group, ASTM working group and recently successfully organized the first science-focused single use international conference through Engineering Conference International (ECI) in Oct 2015 (US) and May 2017 (EU), which is being converted into series. Before Genentech, she worked as a Staff/Senior Engineer in the Technical Operations and Engineering and the Technology Departments at Merck. Ekta has a BS in Chemical Engineering from the Thapar Institute of Engineering and Technology (TIET) in Punjab, India and a MS in Chemical Engineering from Bucknell University.
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.