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3rd Extractables & Leachables Online Conference

  • 27th October 2022
  • ONLINE flag ONLINE

The characterisation of extractables and leachables (E&L) for drugs, biologics, and medical devices to ensure product safety has matured in the last few years. E&L risk assessment is critical to the biopharmaceutical drug development and manufacturing processes.

Since new and more complex pharmaceutical manufacturing and delivery systems are continually developed, many ongoing practical issues and insights around E&L are generated, the current E&L regulations are evolving, and new regulatory requirements are rising.

The analytical, toxicological, and regulatory experts in the field of extractables and leachable will focus at the #VLEnL by Vonlanthen on ensuring safety, quality, compatibility, and regulatory compliance for drugs, biologics, medical devices, and combination products.

Join technical presentations, case studies, participate in Q&A and interactive panel discussion, and explore practical strategies, perspectives, and partnership opportunities at the 3rd Extractables & Leachables (E&L) Online Conference on October 27, 2022.

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About the 3rd Extractables and Leachables (E&L) Online Conference #VLEnL by Vonlanthen)

The characterisation of extractables and leachables (E&L) for drugs, biologics, and medical devices to ensure product safety has matured in the last few years.

E&L risk assessment is critical to the biopharmaceutical drug development and manufacturing processes.

Well-designed E&L studies, robust analytical testing, and consistent chemical and toxicological assessment are required to perform comprehensive E&L assessment.

Since new and more complex pharmaceutical manufacturing and delivery systems are continually developed, many ongoing practical issues and insights around E&L are generated, the current E&L regulations are evolving, and new regulatory requirements are rising.

Addressing current and future challenges of E&L analysis is crucial, including the understanding of:

  • Evolving E&L regulations
  • The increasing complexity of medical devices, new materials, and sensitivity of testing equipment
  • The lack of the specific guidelines for E&L studies in area of novel therapeutics and emerging cell and gene therapy (CGT) products
  • How to bridge the gaps between end user expectations and supplier capabilities
  • …and many more

The analytical, toxicological, and regulatory experts in the E&L field will focus on ensuring the safety, quality, compatibility, and regulatory compliance for drugs, biologics, medical devices, and combination products.

Following the recent revisions to USP chapters as well as FDA guidance, participants of the #VLE&L online conference will get a toolbox and best practices in materials and chemistry characterisation to speed up and strengthen their process qualifications, ensuring high product quality and patient safety.

At the #VLE&L Summit, key experts, advisers, and practitioners will focus on:

  • Strengthening E&L risk assessment for drugs, biologics, and medical devices
  • Overcoming common analytical constraints related to E&L study design
  • Leveraging current toxicological requirements for E&L
  • Implementing new technologies, advanced analytics and applied informatics, digitalisation, and automation to advance the E&L field
  • Meeting regulatory expectations for E&L in drug products, delivery systems, medical devices, and packaging
  • Overviewing the guidelines and recommendations for a successful selection, fast qualification, and safe use of container closure systems (CCS) and polymeric single-use systems (SUS)
  • Understanding future trends as well as uncertainties in E&L analysis
  • Gaining insights on E&L related to novel therapeutics, including messenger RNA (mRNA), cell and gene therapies, and combination products

Learn from technical presentations and case studies, participate in Q&As and interactive panel discussions, and explore practical strategies, perspectives, and partnership opportunities at the 3rd Extractables & Leachables Online Conference on October 27, 2022.

Who should attend:

Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specialising in:

  • Active Pharmaceutical Ingredient (API)
  • Analytical Science
  • Assay Development
  • Bioprocessing
  • Carcinogens
  • Chemistry (Analytical, Organic, Medicinal, Protein)
  • Chemistry, Manufacturing and Controls (CMC)
  • Container Development
  • Device Engineering
  • Drug Development
  • Drug Safety
  • Elemental Impurities
  • Extractables & Leachables (E&L)
  • Formulation
  • Genetic Toxicology
  • Genotoxic Impurities (GTIs)
  • Genotoxicity
  • Good Laboratory Practice (GLP)
  • Good Manufacturing Practices (GMP)
  • Impurities
  • In Silico
  • Manufacturing Science and Technology
  • Materials Science
  • Medical Devices
  • Microscopy
  • Mutagenic Impurities
  • Mutagenicity
  • N-Nitrosamine
  • Organic Synthesis
  • Packaging and Labelling
  • Parenterals
  • Permitted Daily Exposure (PDEs)
  • Pharmaceutical Analysis
  • Product and Process Development
  • Purification
  • Quality Assurance (QA)
  • Quality by Design (QbD)
  • Quality Control (QC)
  • Quantitative Structure-Activity Relationship (QSAR)
  • Regulatory
  • Regulatory Affairs
  • Safety Assessments
  • Standardization
  • Testing
  • Toxicology
  • Validation

REQUEST A BROCHURE

To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.

Dr. Atish Sen, US

Senior Scientist

AstraZeneca

Sandi Schaible, US

Sr. Director of Analytical Chemistry and Regulatory Toxicology

WuXi AppTec

With over 30 years’ experience, Sandi Schaible is responsible for oversight and direction of WuXi AppTec’s analytical chemistry and regulatory toxicology departments in St Paul, Minnesota, USA. The analytical staff she manages is responsible for providing custom chemistry testing services including extractables/leachables, materials characterisation and target analysis testing, method development, and method validation, as well as completing risk assessments and biological evaluations.

Sandi received her bachelor's in chemistry from Winona State University, and has experience working in the pharmaceutical, medical device, environmental, and R&D industries, including over 15 years of analytical experience in GLP, GMP, FDA, and ISO regulated laboratories. She provides technical guidance and testing program design, and is an international and US delegate for TC 194, the technical committee for ISO 10993.

Dr. Carla Landolfi, IT

Founder & Toxicology Risk Assessor

ToxHub

Dr. Carla Landolfi has about 25 years of experience in toxicology field gained in the pharmaceutical industry, eight of them as manager to a toxicology group. She has solid knowledge in the development of safety programs for pharmaceuticals, cosmetics, food supplements, medical devices, biocides, and other consumer products.

Carla has broad experience with regulatory national and international guidelines and rules (ICH/EMA/FDA/GLP/ISO) and she has been the main or co-author of several papers and posters, published in peer-reviewed journals. She's also a professor at university masters as well as a founding editor of Archives of Clinical Toxicology.

Jason Creasey, UK

Managing Director

Maven E&L Ltd

Jason Creasey is a graduate Analytical Chemist. He set up in 2019 as an independent consultant providing advice on the topic of extractables and leachables (E&L), after working for GSK in the area of extractables and leachables since the mid-1990s. 

Over that time, he has seen demand in this area grow exponentially, and Jason has held roles of increasing seniority in relation to providing support to extractables and leachables. Before setting up Maven E&L Ltd - a specialist consultancy for all things E&L related, he was the director of a team of analytical chemists who are responsible for GSK’s global R&D support for E&L activities across a wide range of product types and modalities. He has had the pleasure of commenting on OINDP PQRI guidelines on E&L for GSK and co-authoring a chapter within a book entitled “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products”.   

Since setting up Maven E&L; he continues to present, discuss, and write about E&L. He is a scientific advisor to Extractable and Leachable Safety Information Exchange, otherwise known as ELSIE. He is now publishing a regular E&L blog through LinkedIn and his Website (www.MavenEandL.com), recently adding an E&L Forum for the exchange of ideas. As well as supporting client projects - among recent E&L activity, he is working and commenting on risk-based approaches to E&L requirements that he hopes will form part of an ICH guidance in the not too distant future.

Dr. Dujuan Lu, US

Manager/Global Leader-E&L

SGS

Dr. Dujuan Lu serves as the manager for the E&L team at the SGS Health Science Fairfield, New Jersey, facility as well as the global leader amongst the global E&L centres of excellence. Dujuan obtained her PhD in analytical chemistry from the University of Pittsburgh and has extensive CRO and pharmaceutical/medical device industry experience with more than 500 E&L projects. She was named one of the top 60 most influential people working in the pharmaceutical industry in the Medicine Maker’s 2020 power list.

Dr. BM Rao, IN

Pharmaceutical Analytical & Quality Expert

Dr. BM Rao possess a PhD in chemistry and has about 31 years of work experience in pharmaceutical analytical R&D, quality control, and assurance functions in reputed organisations including Janssen (pharmaceutical companies of Johnson & Johnson), Novartis, Zydus Cadila, Nicholas Piramal, and Dr. Reddy’s. He has extensive hands-on experience on analytical instruments related to chromatography, spectroscopy, and thermal analysis. He has exposure to various regulatory audits includes USFDA, EMEA, TGA, Health Canada, etc., and worked with reputed international consultants in QC remediation. He has about 80 scientific publications in reputed peer reviewed national/international journals and successfully guided eight part-time PhD candidates. During his professional career he has been recognised for his contributions at work and won awards including Chairman’s Excellence Award from Dr. Reddy’s Laboratories (Feb. 2018 and Jan. 2003), Standards of Leadership from J&J at Janssen, Mumbai site (2010), and Best New Leader Award at SAI Life Sciences Limited (2013). He has extensively travelled to USA, Mexico, Germany, Belgium, Singapore, Brazil, and Malaysia, and interacted with several big and emerging biotech pharmaceutical analytical and quality experts. Since September 2015, he has been working as head of quality for emerging markets, analytical science and technology (ASAT), and corporate quality control at Dr. Reddy’s Laboratories and providing technical leadership to the analytical method validations/transfers and quality control labs of APIs and formulations.

Dr. Jianwei Li, US

Chemical Characterisation Consultant & Technical Writer

Chemical Characterization Solutions LLC

Dr. Jianwei Li is currently the principal E&L consultant and chemistry writer at Chemical Characterization Solutions LLC in the areas of E&L evaluation, chemical characterisation, biocompatibility, and compatibility of drug-device combination products. He worked at Medtronic for nearly 16 years as a chemistry subject matter expert and technical fellow. In this role at Medtronic, he worked with a team of analytical chemistry, toxicology, and biology professionals whose primary responsibility includes the application of diverse analytical strategies and methods for the discovery, identification, and quantification of trace constituents in drug-device combination products and medical devices. Foremost among these activities was the initiation and establishment of one of the best analytical laboratories to perform the drug product E&L analysis and medical device chemical characterisation. He also worked for 3M for eight years in its pharmaceutical business. Over the course of his nearly 23-year industry career, he has published extensively in the areas of analytical chemistry with nearly 45 publications and served as frequent scientific reviewers for over 10 international journals.

He received his PhD in analytical chemistry from Purdue University, USA, and did his postdoctoral research at the University of Minnesota, USA.

Dr. Steven A. Watt, DE

Head of Business Development

A&M STABTEST Labor für Analytik und Stabilitätsprüfung GmbH

After studying molecular biology at Bielefeld University and graduating with a PhD in genetics and molecular biology in 2005, Dr. Steven Watt was granted a position as an assistant professor. There, he was in charge of a mass spectrometry service unit, dealing with proteome and metabolome projects. In 2009, he joined a vendor of scientific instruments as an instructor for pharmaceutical mass spectrometry applications. In his current position as head of business development at A&M STABTEST, he is in charge of customer relations, marketing, and sales. He also acts as scientific advisor for the development of new analytical services in the field of biopharmaceutical analysis.

Nicholas Morley, UK

Principal Scientist

Element Manchester (Formerly Hall Analytical)

Nick Morley is a principal scientist at Element Materials Technology responsible for providing technical support to new and existing pharma, med device, and consumer products for customers in the field of extractables and leachables. He has over 15 years of experience in the field of E&L, both in large pharma and at a CRO. Nick’s area of expertise includes E&L study design, defining E&L strategies, performing leachable risk assessments, and authoring E&L regulatory sections. Nick is the E&L expert on the British Standards Institute (BSI) and European Standards Committee (CEN) for electronic cigarettes and e-liquids. Nick has presented on a number of different E&L related topics internationally and has developed and run pre-conference workshops on E&L assessment at a number of international conferences.

Prior to joining Element Material Technology, Nick spent over 10 years at GSK in the field of E&L. During this time, he worked on a range of therapeutic areas including inhalation, topical, and parenteral. Where he had responsibility for the E&L assessment of devices, closure systems and manufacturing processes to ensure patient safety, product quality, and regulatory approval. Whilst at GSK, Nick was a member on one of the ELSIE (Extractable and Leachables Safety Information Exchange) working groups.

Dr. Paulo Eliandro da Silva Junior, BR

Technical and Regulatory Director

INTEGRA CONSULTANCY

Dr. Paulo Eliandro da Silva Junior is a pharmacist-biochemist (USP) with a master's and PhD in medicinal chemistry, synthesis and drug discovery (FCFRP-USP, University of East Anglia – UEA, UK; Johannes Gutenberg University of Mainz – JGU, Germany). Paulo's experience in the pharmaceutical industry started in 2013 as a trainee at Novartis, Horsham, UK, in the global discovery chemistry department. After that Paulo worked mainly in regulatory affairs, quality audits, and drug product and drug substance development with focus on impurities control, including E&L, mutagenic impurities, such as nitrosamines, in his own consulting company, Integra Consultancy. Paulo also is a founder of another company, BIND, which is a startup for synthesis and characterisation of analytical standard for development processes, and teaches postgraduate courses that cover various pharmaceutical topics.

Dr. Simone Biel, DE

Senior Regulatory Consultant / Life Science, Quality & Regulatory Management

Merck KGaA

Simone Biel is a Senior Regulatory Consultant and provides regulatory expertise to our customers and internal stakeholders with a focus on Single-Use Technology and filtration. Over the years, Simone has supported biopharmaceutical drug manufacturer’s implementation of Single-Use Technology in their manufacturing process and gained a deep understanding of market needs and industry trends in this field. Her objective is to ensure that product performance meets quality and regulatory requirements.

Simone holds a Ph.D. from the University of Frankfurt in Microbiology.

Mike Ludlow, UK

Science Lead, Analytical and Materials Science

Drug Development Solutions

Mike Ludlow is science lead for the analytical and materials science division within Drug Development Solutions (formerly LGC). He is an analytical chemist with over 25 years’ experience in chromatographic and spectroscopic techniques, specialising in the area of extractable and leachable testing and impurity characterisation.

In his current position, Mike provides technical support to operational and commercial colleagues and to an extensive client base, primarily focussed on the pharmaceutical and consumer healthcare sectors. He has presented at numerous international events on topics including extractables and leachables, genotoxic impurity analysis, and experimental design.

Mike is currently on the Register of Specialists for the UK Government Office of Product Safety and Standards (OPSS). He previously worked for ICI Chemicals and Polymers division where he was responsible for the NMR area providing support to the research function at Runcorn in the UK.

Mike holds a BSc Hons in applied chemistry, an MSc in analytical chemistry, and an MBA from Warwick Business School.

Dr. Atish Sen, US

Senior Scientist

AstraZeneca

Sandi Schaible, US

Sr. Director of Analytical Chemistry and Regulatory Toxicology

WuXi AppTec

Dr. Carla Landolfi, IT

Founder & Toxicology Risk Assessor

ToxHub

Jason Creasey, UK

Managing Director

Maven E&L Ltd

Dr. Dujuan Lu, US

Manager/Global Leader-E&L

SGS

Dr. BM Rao, IN

Pharmaceutical Analytical & Quality Expert

Dr. Jianwei Li, US

Chemical Characterisation Consultant & Technical Writer

Chemical Characterization Solutions LLC

Dr. Steven A. Watt, DE

Head of Business Development

A&M STABTEST Labor für Analytik und Stabilitätsprüfung GmbH

Nicholas Morley, UK

Principal Scientist

Element Manchester (Formerly Hall Analytical)

Dr. Paulo Eliandro da Silva Junior, BR

Technical and Regulatory Director

INTEGRA CONSULTANCY

Dr. Simone Biel, DE

Senior Regulatory Consultant / Life Science, Quality & Regulatory Management

Merck KGaA

Mike Ludlow, UK

Science Lead, Analytical and Materials Science

Drug Development Solutions

BROCHURE 

Request the 3rd Extractables & Leachables (E&L) Online Conference brochure and find out the latest topics and ideas that will be shared.

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What our
participants
are saying

I found very useful the program content, and especially concerning to the E&L future testing trends.

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Attendee

Currently there is a lack of knowledge in E&L related to the novel modalities. The #VLEnL by Vonlanthen gained important insights to consider.

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Past

Attendee

The success of the #VLE&L conference is in the carefully chosen case studies, presented by the key subject matter experts in the area of extractables and leachables.

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Attendee