Cambridge Healthtech Institute’s Second Annual
Extractables and Leachables
PepTalk: The Protein Science Week
January 13-19, 2014
In biopharmaceutical drug development and manufacturing, containers, drug combination products (inhalers, pens, insulin pumps and implants), and even disposable equipment may release low molecular weight chemicals into the product and possibly compromise the biological safety and efficacy of the drug product. This conference covers how testing for extractables and leachables (E&L) should be conducted, how to control E&L in drug product, how to comply with regulatory guidance, and how to ensure the quality of your product.
Join with colleagues from around the world in this discussion of the key challenges and solutions for E&L testing and see how experts are avoiding impurities to deliver a safe and stable product.
We invite presentation proposals on the following preliminary topics:
Review of regulatory expectations for extractables and leachables (E&L) in drug products
Status update on guidelines from government and industry working groups such as United States Pharmacopeia, PQRI PODP, IPAC-RS, BPSA, BPOG, and ELSIE
E&L challenges associated with PODPs (Parenteral and Ophthalmic Drug Products) and administration systems
Toxicological perspectives and evaluation of E&Ls: Study design, risk assessment and mitigation of challenges in E&L studies
Chemical Assessment Triad and its application to packaging systems safety assessments
Primary and secondary packaging: Choice of right packaging material, heat capacity, choice of container material
Choice of right packaging materials for emerging markets, implication in cold chain supply
Working collaboratively: Component vendors, contract labs, partners, chemists and toxicologists, and the regulatory agencies
Understanding risks in the supply chain and opportunities for outsourcing
Glass delamination: E&L challenges posed by glass delamination, generation of visible and sub visible particles
Analytical strategy for E&L: Analytical characterization of extractables in control extraction studies and LOQ
Analytical strategy for E&L: Analytical characterization of leachables (establishing correlation with extractables)
How to perform analytical testing, what methods to follow and to what extent analytical testing needs to be performed
E&Ls challenges and opportunities: Case studies on single-use systems
Defining current E&L requirements for infusion systems, dialysis and self administration devices
Quality by Design (QbD) for E&L
Case studies on interaction between E&L and protein(s) in the formulations and formation of immunogenic agents.
Please visit click here to submit a speaking proposal for review.
Deadline for submission: June 7, 2013
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, 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