The ever-changing world of E & L Part 4

The Ever-Changing World of Extractables and Leachables 4. May 18th 2022.

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Conference Running Order (BST)

15:00 Introduction
15:05 Chris Houston
“Challenges and Lessons Learned in the Study of E&L in Ophthalmic Drug Products”
15:30 Samuel Albeke
“Sample Enrichment Approaches for Extractable and Leachable Studies”
15:55 5-Minute Break
16:00 Shane Smith
“Case Study: Assessment of the leachables risk from change
to a small SUS component  in a biopharmaceutical manufacturing process”
16:25 James Pink
“Article 117 of the EU medical device regulations and the new
Notified Body Opinion for drug device combination products”
16:55 5-Minute Break
17:00 Gyorgy Vas
“Impact of the GC-MS Injection Solvent and the Analyte Concentration
on Relative Responses for Common Extractables”
17:25 Allan Ader
“Establishing Permitted Daily Exposure (PDE) Values for Extractables & Leachables
into Drug Products: Examples of Lots of Data and No Data”
17:50 Panel Discussion
“TBC”

Speakers

Christopher T. Houston
Senior Principal Scientist and Group Leader – Bausch & Lomb

Chris Houston has 22 years of experience as an analytical chemist in the pharmaceutical and medical device industries. He started his career at Pharmacia & Upjohn (later Pharmacia, then Pfizer) in Kalamazoo, MI as an analytical scientist focused on chromatographic method development and extractables and leachables (E&L) in ophthalmic drug products. He joined Bausch & Lomb at the Rochester site in 2006 as head of the centralized mass spectrometry facility, becoming a founding member and eventual leader of a multidisciplinary spectroscopic structure elucidation group. During this time, he created and managed a successful E&L program for ophthalmic pharmaceuticals and served as a member of the PQRI Working Group on E&L in Parenteral and Ophthalmic Drug Products. Chris has also held roles as an E&L consultant, director of a contract analytical laboratory, and in QA. He currently leads Bausch & Lomb’s Pharmaceutical Development-Chemistry group. He holds a B.S. degree in Chemistry from the University of Michigan-Flint and a PhD in Analytical Chemistry with a Biochemistry minor from Indiana University.


Samuel Albeke
LC Manager at VR Analytical

Sam started his career as an R&D chemist formulating coating formulations with the same additives that he now spends his time detecting and identifying in the extractables and leachables industry. Sam has gained expertise in sample preparation to tackle chromatographically challenging matrices. He manages an exceptional team of liquid chromatographers at VR Analytical, an E&L industry leader.


Shane Smith
Managing Director of ExtLe Solutions Limited

Shane Smith is the Managing Director of ExtLe (pronounced X-TEL) Solutions Limited, a company based in Cambridge in the UK. He has over 37 years of experience in industrial analytical chemistry, with three quarters of that time spent in the pharmaceutical sector. As well as being an expert on extractables and leachables (E&L), he is a specialist in trace analysis and the separation sciences.

From 2004, he worked for GlaxoSmithKline’s world class E&L team at Stevenage in the UK, managing E&L projects for global cross-site project teams. He was ultimately responsibility for the E&L content of successful product registrations across the world including North America, Europe, and other territories.

Shane left GlaxoSmithKline in early 2016 to pursue a career as an Independent Consultant and set up ExtLe Solutions to provide specialist consultancy services on E&L and other CMC related activities.

With well over 40 years’ combined experience dealing with E&Ls in an ever increasingly complex regulatory environment within the pharmaceutical industry, Shane and the team at ExtLe Solutions provide robust, scientifically sound E&L strategies for their clients’ products.


James Pink
Senior Director, Medical – Element Materials Technology

James Pink has over 20 years of experience in the medical devices industry including 10 years as a healthcare technology expert and lead auditor for a leading European notified body.

He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK.

His industry experience includes managing product development and quality assurance programs for active and non-active implantable and combination products. James is a contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards.


Gyorgy Vas Ph. D.
Business Technical Scientific Liaison, Intertek Pharmaceutical Services

Gyorgy Vas has over 20 years of experience in scientific research, pharmaceutical and medical device product development, and laboratory management. More than half of this time was spent in a cGMP environment, where that scientific expertise was applied to solve problems related to finished pharmaceutical products and medical devices. In his current position, he is advising regulatory filing strategy for multiple clients, and his group provides solutions for mitigate deficiency letters. 

He is serving as an internal scientific consultant to the laboratory operations, evaluating new analytical techniques, software products for extractables and leachables testing. As part of his current role he is involved to evaluate and implement non-routine analytical instrumentations and methods for cGMP use. He recently published two scientific papers for E&L testing. His papers have been cited more than 3000 times over the years.


Allan Ader, Ph.D, DABT
Co-founder and co-Managing Director of SafeBridge Consultants, Inc.

Allan Ader, Ph.D, DABT is co-founder and co-Managing Director of SafeBridge Consultants, Inc., now doing business as the SafeBridge Regulatory & Life Sciences Group, the premier resource for high level risk assessment, safety, health and environmental support to the biotechnology and pharmaceutical industry.  Dr. Ader has extensive experience in:

  • Performing health-based risk assessments including Permitted Daily Exposures (PDES) including evaluating toxicological and exposure information to determine potential health effects of chemicals,
  • Developing Occupational Exposure Limits and assessing compounds for toxicity and potency for compound categorization / banding and recommending handling practices and controls based on the toxicity/potency characteristics;
  • Assisting companies in testing of chemicals for their toxic effects and interpreting data from these tests, and
  • Responding to crises caused by occupational health illnesses from chemicals by assessing and evaluating risks and communicating them to employees and management.

Dr. Ader has over 30 years of experience in the pharmaceutical and chemical industry including working for Syntex, Inc. in Palo Alto, CA and Olin Corporation, New Haven, CT.  He received a Ph.D. in Industrial Health (Toxicology) from the University of Michigan and an M.S. in Industrial Hygiene from Temple University.  He is a Diplomate of the American Board of Toxicology.


Moderator

Andrew Feilden. Hall Analytical.

Dr Andrew Feilden is the European E&L Strategic Director at Hall Analytical.  He joined Hall in November 2019 where he is a technical expert in the field of E&L testing undertaking commercial, operational and technical thought leadership activities. He has presented on the field of extractables and leachables in over 16 countries world wide.  Andrew has written a number of papers and publications and is the inventor of 2 patents. He has a degree and D Phil from the University of York, is a Fellow of the Royal Society of Chemistry and was a Scientific advisor to IPAC-RS and ex-cochair of ELSIE