THE CHALLENGES IN CONTROLLING EXTRACTABLES AND LEACHABLES are driving drug and biologic manufacturers and their vendors to explore new ways of comparing experience and sharing information. As product, process, packaging and delivery materials and systems evolve and their interactions grow more complex, industry is looking for pathways to make the E&L evaluation process more efficient and effective, and new collaborations are being formed that reach across the supply chain and the product lifecycle. Regulators, in turn, are voicing support, offering the new quality-by-design concepts as guideposts. Having put forth inhalation/nasal product E&L recommendations, the Product Quality Research Institute is now focusing on parenterals and ophthalmics. Other manufacturer and vendor collaborations are developing an E&L database and/or best practices to help simplify the evaluation process. Sensitive products and complex processes heighten the challenges in the biotech context.
VOICES FROM THE DIALOGUE:
• PQRI research proposal on E&L for parenterals and ophthalmics (pp. 5-8)
• CDER CMC official Chen on a QbD Approach To E&L (pp. 9-11)
• Bio-Process Systems Alliance on E&L for single use systems (pp. 17-19)
• CBER compliance official Yu on current E&L concerns (pp. 22-24)
• CDER case studies of leaching problems in biotech products (pp. 25-26)
• Summary of biotech CMC strategy forum discussions on E&L by Amgen’s Mire-Sluis (pp. 30-40)
CONTENTS:
2……PQRI E&L Guide Reflects Lab Research
3……PQRI Turns To Parenterals/Ophthalmics
8……IPAC-RS Looking At QbD Integration
9……PDA E&L Forum Explores QbD Impact
13….E&L Database Effort Gains Momentum
14….Vendors Offer Single-Use System Guide
15….Biotech E&L Forum Backs Database Idea
20….Existing Information vs. New Research
27….Two Key Cases Show Biotech Quandaries
28….Leachate Role In Eprex Case Questioned
