Do Extractable Protocols Truly Help – An End User Perspective

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, Genentech/Roche
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 Sartorius Stedim Biotech

 
Sartorius Stedim Biotech is a leading international supplier of products and services that enable the biopharmaceutical industry to develop and manufacture drugs safely and efficiently. As a total solutions provider, Sartorius Stedim Biotech offers a portfolio covering nearly all steps of biopharmaceutical manufacture. The company focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Headquartered in Aubagne, France, Sartorius Stedim Biotech is quoted on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and an international network of sales companies, Sartorius Stedim Biotech has a global reach. In 2016, the company employed approx. 4,700 people, and earned sales revenue of 1,052 million euros.
Presented by Dr. Armin Hauk
Armin started his carrier at Ciba in Basel, Switzerland 1995. He was responsible for the GLP & GMP lab for organic analysis, migration studies, E&L investigations, development of GMP QC methods and stability testing. After 2010 Armin worked as consultant and Qualified Person (QP) for Intertek Chemicals & Pharmaceuticals in Basel. Since 2016 Armin has a position at Sartorius-Stedim Biotech as Lead Scientist. Armin is lecturer and trainer in E&L conferences and seminars and he is delegate of the German BfArM in the EDQM Pharmacopeia expert group.