January 18-22, 2016 | Town and Country Resort Hotel | SAN DIEGO, CA 
January 18-22, 2016 | Town and Country Resort Hotel | SAN DIEGO, CA 

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Cambridge Healthtech Institute’s Fourth Annual
Extractables and Leachables
Protecting Quality of Biologics by Ensuring Safety and Compatibility
January 21-22, 2016


In biopharmaceutical development and manufacturing, containers, drug combination products, and even disposable equipment may leach chemicals into the product that can pose significant risks to product quality and potentially compromise the stability, safety and efficacy of the biotherapeutics. The Fourth Annual Extractables and Leachables (E&L) conference brings together industry experts and thought leaders to share their insights on latest updates and guidelines, how to design analytical testing strategies for E&L, case studies on identification and risk assessment E&L in single-use system, container closure system and delivery devices, and impact of leachables on biologics safety. We are looking for cutting-edge research findings and unpublished data to be featured at this forum.

We invite you to submit a proposal, present a poster and join colleagues from around the world in this discussion of the key challenges and solutions for E&L testing in biologics.

We invite presentation proposals on the following preliminary topics: 

  • Regulatory expectations and updates on guidelines from government and industry working groups such as United States Pharmacopeia, PQRI PODP, BPSA, BPOG, ELSIE, ISO and ASTM
  • Toxicological perspectives on safety assessment of E&L:
    • Safety thresholds, study design
    • Risk assessment, mitigation of challenges in E&L studies
    • How to assess toxicological impact from production suite and unknown leachables
  • Impact of E&L on stability, potency and immunogenicity of drug substance and drug product:
    • Case studies on interaction between E&L and protein(s) in the formulations
    • Aggregation induced due to leaching and formation of immunogenic agents
    • Predicting interaction between protein and E&L
  • E&L testing for single-use manufacturing systems:
    • Progress, challenges and learnings in single-use systems
    • E&L challenges in ADC conjugation process in single-use production
    • Convenience of single use vs. loss of control on impurities
    • Analytical testing to characterize single-use components for E&L
  • Simulation solvents and migration models for E&L
  • Interactions with process and packaging components: Challenges posed by leachables from glass, glass delamination, tungsten particles and generation of visible and subvisible particles
  • E&L in container closure system and delivery devices: Container closure studies, defining current E&L requirements for infusion systems, dialysis and self-administration devices, implantable devices, pre-filled syringes and process components
  • Analytical strategy and risk assessment to identify critical components and steps: Upstream, downstream, fill and storage

Please click here to submit a speaking proposal for review.

Deadline for submission: June 17, 2015 

All proposals are subject to review by the Scientific Advisory Committee to ensure the overall quality of the conference program. Please note that due to limited speaking slots, preference will be given to abstracts from those within pharmaceutical and biopharmaceutical companies, regulators and those from academic centers. Additionally, as per CHI policy, a select number of vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships. 

For questions about the meeting, please contact: 

Nandini Kashyap
Conference Director
Cambridge Healthtech Institute
Phone: 781-972-5406
Email: nkashyap@healthtech.com 

For partnering & sponsorship information, please contact: 

Companies A-K
Jason Gerardi
Manager, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5452
Fax: 781-972-5470
Email: jgerardi@healthtech.com 

Companies L-Z
Carol Dinerstein
Director, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5471
Fax: 781-972-5470
Email: dinerstein@healthtech.com