Extractables & leachables testing strategy
Risk-based E&L study design. I make sure you're testing the right things - not everything.
The problem
Your single-use components contact patient cells, media, or drug product. Regulators expect E&L data. But studies run $50-200k+ per material system, take 6-18 months, and USP <665> just became mandatory. The risk isn't just under-testing - it's over-testing too. I've seen companies spend six figures testing components that didn't warrant a full study while missing the ones that did.
My approach
Risk-based assessment first. Not every product-contact material needs a full extractables study. Some need controlled extraction, some need literature justifications, some need nothing beyond a materials review. The assessment determines which bucket each component falls into, so you spend money where it matters.
What I deliver
E&L risk assessment
Component-by-component evaluation of which materials need extractables studies vs. alternative approaches.
Study protocols
Extraction protocols covering solvent selection, conditions, analytical methods, and acceptance criteria.
CRO coordination
Vendor selection, study placement, progress monitoring, results review.
Toxicological risk assessment
TTC-based evaluation, safety margin calculations, risk characterization.
Regulatory-ready reports
Final E&L reports organized for CMC sections of regulatory submissions.
Who this is for
Companies with custom single-use components lacking E&L data. Programs needing USP <665> compliance. Companies wanting a second opinion on an E&L program that feels over-scoped or under-scoped.