PepTalk 2017
PepTalk 2017

Pipeline Five Header

Cambridge Healthtech Institute’s Fifth Annual
Extractables and Leachables
Challenges and Approaches for Maintaining Quality and Safety of Biologics in a Dynamic Regulatory Landscape
January 10-11, 2017 | Hilton San Diego Bayfront | San Diego, CA

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 Fifth Annual Extractables and Leachables (E&L) conference brings together industry experts and thought leaders to share their insights on the latest updates and guidelines, how to design analytical testing strategies for E&L, case studies on identification and risk assessment of E&L in single-use systems, container closure systems and delivery devices, and the impact of leachables on biocompatibility and 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 We are looking for cutting-edge research findings and unpublished data to be featured at this forum.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 attend to 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
  • Tools and methods for rapid and comprehensive extractable profiling
  • Understanding mechanism of interaction between E&L and proteins and its impact on stability, potency and immunogenicity of drug substance and drug product
  • Biocompatibility and product contact assessment: new tools, new and improved in vitro/in vivo models and studies, device and container closure safety
  • E&L testing for single-use manufacturing systems, especially case studies on ADC processing and high-potency drugs
  • Establishing device and container closure safety
  • Simulation solvents and migration models for E&L
  • Interactions with process and packaging components
  • E&L in container closure systems 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: May 27, 2016

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

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

Companies L-Z
Carol Dinerstein
Director, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5471
Fax: 781-972-5470