Critical Reagents/Reference Standards Storage, Testing, and Distribution
For any drug development project, it is essential to have a controlled, well-documented system for storing, monitoring, testing and distributing critical reagents and reference standard materials. Eurofins BioPharma Product Testing provides such secure storage, as well as experienced testing and distribution services resulting in a turnkey solution for management of your critical reagents and reference standards. We work with each client to design a customized program, which can include aseptic aliquoting of bulk reagents and reference materials.
Why Choose Eurofins BioPharma Product Testing
- We offer the largest storage capacity and choice of conditions with more than 25 different set points and 30,000 cubic feet of storage space.
- Our expertise in chemistry, biochemistry, microbiology, molecular & cell biology and virology results in the broadest set of testing capabilities in one location for the most complete coverage of the testing required for recertification of your materials.
- Our 30-year history of cGMP regulatory compliance ensures that you get the highest level of quality.
- Our online data access portal, LabAccess.comSM, gives you the ability to monitor set-downs and material inventory. You will also have remote electronic access to your testing/re-certification reports and all associated raw data.
Our storage program includes: < -150 C (LN2), -80C, -70C, -20C, 5C, and 25C (amb) desiccated and non-desiccated. All storage units are housed in a secured area, continuously monitored by our validated Kaye monitoring system and supported by a fully validated computerized laboratory information management system (LIMS) to manage and ensure proper storage and tracking of your materials.
Our laboratories have the testing capabilities for assessment of purity, identity, moisture and most other characteristics of your materials. We will work with you to develop and validate all tests necessary for the materials under your program. Once the testing methods are established, we can recertify material based on schedule or usage. Our services include the establishment of threshold amounts for each material and client notification. Additionally, we will manage your certificate of analysis (CofA) and send copies of the CofA along with any distribution of material.
Services include cold-chain management and secure-monitored shipping for your materials for laboratory testing. Customized order forms and systems can be established during program setup to expedite distribution times.