In the biopharmaceutical industry, storage goes beyond warehousing. A full-service biorepository will likely charge minimum monthly fees to account for the innovative storage facilities, necessary certifications, and regulatory governance guaranteeing a promise of quality. When it comes to irreplaceable materials, our services are necessary to keep your assets safe, secure, and effective.
Biorepository Management Services
Life sciences are constantly developing, and as they do, needs can change. SciSafe agreements are not subject to a new customer cost and include the monthly fee which reserves your space, but are otherwise flexible and adjustable as your needs change. Our agreements ensure that all clients are given the same level of high-quality service, whether they are a small biotechnology start-up or a major pharmaceutical company.
SciSafe offers extra services, with local sample transportation included in your monthly fee if your facility is within 50 miles of SciSafe’s six full-service biorepository facilities. This radius includes major metropolitan areas, such as New York City, Philadelphia, and Boston. for our US locations as well as Amsterdam for our Netherlands site.
Accessing your materials is essential, so we will never charge you for accessing your own samples. Our monthly fees include inventorying those stored within our facilities, sample pulls, report pulls, handling, and initiating shipments. SciSafe’s validated inventory database offers 24/7 viewing of material and real-time temperature monitoring.
Quality Leadership
All our global facilities, regardless of location, operate under the same quality promise and the same Standard Operating Procedures (SOPs), making the monthly minimum fee the same, regardless of location. Some of our facilities have additional registrations to meet the needs of local customers, but all offer the same high-quality full-service biorepository experience.
- All facilities are fully cGMP certified; Quality Department with over 86+ SOPs
- ISO 9001 – all facilities
- CAP Accredited – all facilities
- ISO 20387 – New Jersey facilities only
- FDA CDER & CBER registered & inspected since 2011 – New Jersey facilities only
- EU Farmatec – Amsterdam facility
To see our full list of accreditations and certifications, visit our About Us.
Safety & Security
From protection against power loss to theft, SciSafe has planned for it all. Our facilities have oversized power supplies with redundant HVAC systems, including transformers, to weather any environmental challenge.
There is diesel-generated backup power throughout all locations with automatic transfer switch units to run generators and monitoring systems that alert staff immediately if power goes out. Our buildings are only accessible with controlled card scanning. All sample suites include sample audit logs and closed-circuit televisions throughout the facilities to deliver top-notch security with 24/7/365 monitoring by our onsite security team.
Non-GMP vs. cGMP Storage
Current Good Manufacturing Practices (cGMP) are guidelines stipulated by the Food and Drug Administration (FDA) to ensure drugs/pharmaceuticals, food, and/or cosmetics/personal care products meet minimum safety and quality standards for use as intended.
SciSafe is cGMP compliant as applicable to 21 CFR 210 and 211 for pharmaceuticals for holding and 21 CFR 1271 for holding of HCT/Ps. Its electronic systems, including sample inventory, sample temperature monitoring, document control, and training, are 21 CFR Part 11 compliant.
If any of your products fall within one of the FDA categories, proof that cGMP guidelines were followed will be required for human use. If your products do NOT fall within these categories, cGMP storage is NOT required but may still be desired as it will provide the highest level of control and security for your critical materials.
It’s key to remember that a full-service biorepository charging a monthly minimum storage fee ensures that your valuable materials are protected in top-notch facilities. SciSafe goes the extra mile and offers unparalleled storage and logistics programs, customer service, and quality controls to give you peace of mind. Contact us today to discuss how SciSafe can be your partner in biorepository management.