Strategic Material Storage and Distribution Offerings at Eurofins Lancaster Laboratories

by Travis L. Emig, Senior Director, Pharmaceutical Chemistry/Stability Services

The GMP stability storage operation at Eurofins Lancaster Labs offers many services to our customer in addition to established offerings such as clinical and registration study management for phase II through phase IV commercial programs. With our significant footprint of over 80,000 cubic feet of storage space across two unique buildings in Lancaster, PA, plus additional capacity at our Eurofins site in Portage, MI, we support various analytical based GMP storage and distribution initiatives for the pharmaceutical industry.

Material Storage, sampling and distribution to both domestic and international locations, and analytical laboratory support for characterization and certification performed under full GMP controls is available to our customers. Secure, continuously mapped and monitored, fully GMP compliant chambers, refrigerators, freezers, ultra-freezers and cryogenic LN2 units are available and used for this purpose. All ICH based conditions with redundancy for risk mitigation, are always available, and customized conditions are potentially available upon request.

Types of programs include but are not limited to Master and Working Cell Banks, Cell Line storage and distribution, Critical Reagent storage including certification and distribution, for analytical support and contingency. Eurofins provides bulk retain of commercial product, bulk retain of API, and reference standard storage, certification, and distribution. Viral Stock management is also in our portfolio.

Eurofins offers several differentiators in the storage attributes of our business:

• Eurofins ability to handle most materials from a safety management perspective is unique in the industry. Highly potent, acute toxic, class I-V controlled substances are generally accepted. Laboratory and sampling controls are in place through the use of industrial ventilated balance enclosure systems, isolated weighing rooms, environmental humidity control space, and training for respirator use when necessary. Eurofins will screen and assess all material SDS information prior to any program initiation.
• Eurofins software management tools allow storage to be managed at study levels, provide inventory controls, track re-certification schedules, and allow a client interface through LabAccess to monitor this critical information at any time.
• Our stability project management team, in conjunction with lab operations, typically processes orders for sampling and distribution of materials within 24-48 of your request. Eurofins can work with various couriers for shipping and distribution and whether cold chain storage is required or just temperature controlled shipping, our staff will utilize controlled shippers and temp tale monitoring as supplied by us or the customer to achieve necessary controls.

If you have GMP storage capacity limitations in your organization and are looking for a partner to supplement various analytical purpose storage needs, please reach out to us for consult and assessment. Eurofins is here to support your organization’s immediate and long term storage needs.