Overview
SciSafe offers dedicated Pharmaceutical & Biological Specimen Storage in our fully cGMP compliant state-of-the-art facilities (5 in the US). All facilities are ISO 20387/ISO 9001 certified, FDA registered & inspected (CDER & CBER), with 86+ Standard Operating Procedures (SOP’s) modeled after FDA (21 CFR parts 210 & 211), GDP, and CAP-BAP (College of American Pathologists Biorepository Accreditation Program) certified as of 2023. Meaning that we meet the highest standards of quality, accuracy, and consistency from the FDA, OSHA, and CLIA.
We store at temperatures between -196°C to +40°C and offer custom storage solutions. Types of samples we store include reagent storage & fulfillment, cell line, compound libraries & mirror banking, pre-clinical research & trials, clinical trial storage with patient efficacy testing, DNA storage & fulfillment, vaccines, CAR-T and immunotherapy, bulk materials, stability testing, drug substance, and biological ingredients.
We make outsourcing palletized pharmaceutical material storage affordable, easy, and more efficient for our clients with palletized storage in temperatures ranging from -50°C to +30°C ambient.
Sample Transport – Scheduled sample pick-up & delivery to the bench is available with our storage service.
Freezer Transport – Wherever you are in the country, we can move your freezers to one of our US biorepositories. We will transport -80°C to -20°C in our fleet of refrigerated and ultra-low temperature (ULT) truck trailers. This fleet provides ideal transportation for any movement of biologic products requiring ULT storage without the added need for dry ice. Running on generator power with two cooling systems, the fleet can also carry up to 10 plugged in, powered, and running upright ULT freezers at a time with temperatures as low as -86°C with monitoring equipment to track location and trailer temperatures in real time.
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