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, 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 KGaA, Darmstadt Germany. 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 KGaA, Darmstadt Germany

Merck KGaA, Darmstadt Germany 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.
Followed by Standardized protocols for generating extractables data on Filtration and Single Use Systems – An analytical perspective
The Biopharmaceutical industry has always been aware of the risk of using disposable technology such as filters and Single use systems in their processes despite their several unique advantages. The ability to control and mitigate the risk from extractables and leachables to a product and the patient safety highly depends on the availability of the complete extractables profile for these products. In the recent years, tremendous efforts have been made towards standardization of the Extractables test methodology both from the perspective of using the right extraction methods and the enhancement of analytical techniques. This discussion will focus on the challenges and advantages using the various model solvent streams in the standardized test methods and their relative comparison. In addition, the focus would also be on the unknowns arising from the analysis using such model solvent streams.
By Dr. Saskia Haehn, Laboratory Manager for Extractables & Leachables at Central Analytics of Merck KGaA Darmstadt, Germany. 

Saskia studied organic chemistry at the Saarland University in Germany with a focus on analytical chemistry, especially gas chromatography mass spectrometry. After her PhD she worked for a contract lab as project manager for E&L to support clients from the pharmaceutical and medical industry. In 2014 Saskia joined Merck KGaA, Darmstadt Germany where she set up the laboratory for E&L in Central Analytics. She applies technical and regulatory knowledge, scientific experience and expert judgment to address solutions for a broad range of difficult problems. In her role she is also responsible for generation of extractables information for Emprove® Dossiers.