Extractables and Leachables

Avoid contamination early in drug development

The assessment of extractables and leachables in bio/pharmaceutical products is an important step in drug product development. Processing equipment as well as primary and secondary container closures are potential vectors for chemical contaminants.

Monomers and polymer additives such as antioxidants, plasticizers, stabilizers, dyes, metal catalysts and other harmful chemicals may potentially migrate into the product under storage conditions. Synergy Bioscience provides a complete service for testing extractables in container materials and leachables in final products. These tests are conducted in cGMP-compliant laboratories using technologies that detect ultra-trace levels.

Regulations make extractables and leachables studies an essential part of your development process. Synergy Bioscience provides full analytical support for extractables and leachables testing. Our dedicated and highly specialized team has more than 15 years of experience supporting numerous studies for various container/closure selections as well as process qualification and validation for different manufacturing processes.

Additionally, we can deliver an integrated toxicity/safety evaluation by experienced and American Board of Toxicology-certified toxicologists familiar with the application of PQRI recommendations. Our extractable/leachables team and toxicology experts work together to help you make informed decisions on which extractable compounds will be monitored as leachables in long-term stability studies.

Our extractables and leachables capabilities include

  • Full extractables/leachables program support for (but not limited to):
    1. Pressurized metered dose inhalers (pMDIs)
    2. Nasal spray solution/suspension
    3. Injectables in bags/vials
    4. Lyophilized product
    5. Stoppers, vials, syringes, bags, nasal spray pumps, labels, adhesives/inks, implantable devices, tubing, resin, film, caps, foil, e-flow devices, gaskets, valves, and disposable materials used in bioprocess (single-use) Manufacturing
  • Material and process qualification and validation for in-process manufacturing from an extractables/leachables perspective
  • Controlled extraction studies with LC-MS, GC-MS direct injection, and GC-MS headspace injection sample analyses with data interpretation and toxicity assessment services
  • Leachables method development and validation studies
  • Material qualification for polynuclear aromatic hydrocarbons (PAH), N- nitrosamines, and other toxicologically concerned compounds
  • Leachables monitoring for stability studies and routine extractables testing
  • Reference standards for many extractable compounds commonly formed during the manufacturing process of the container/closure systems or their resins, including some that are not commercially available

We have extensive experience performing container closure qualifications for all types of container closure systems, designing extractables and leachables programs, and employing Quality by Design (QbD) principles to inform development decisions and meet regulatory requirements for E&L data in an efficient and economical manner.

Our scientists are armed with decades of trace impurity characterization experience, a large arsenal of mass spec and other instruments, and uncompromising resolve. Our state-of-the-art equipment, including HPLC-Orbitrap and Q-TOF mass spectrometers, provide the high-end identification horsepower required for this type of trace analysis.

We offer expert program design and regulatory support, employing a well-defined process to optimize your data package while actively managing “scope creep” often associated with extractables and leachables development. We begin by detailing a program customized to the route of administration and unique characteristics of your drug so deliverables, timing, and costs are predictable.

We’ve drafted sections of multiple NDAs, provided strategic program design to respond to time-bound FDA requests, and drafted responses to FDA deficiency letters.

Contact us to learn how we can help with your extractables and leachables testing, and determine the right strategic fit in your drug development program.

To discuss how Synergy Bioscience can help you, please contact us