Whether a biotech start-up or well-heeled pharmaceuticals, many companies face the same challenges when it comes to sample management. It is vital to your business that you have reliable, dependable, auditable, and compliant biological sample management in place.
In order to reduce the risk of corrupted samples and avoid the risk of non-compliance, the right biostorage solutions will have real-time solutions to prevent sample contamination.
Regulations for Pharmaceutical and Biological Sample Management
The FDA has developed pages and pages of regulations to improve the safety and integrity of biopharmaceutical sample management. Every processing stage of the samples is now regulated, which includes:
- How samples are stored
- How long samples are to be kept
- Shipping, handling, and chain of custody documentation
There are a wide range of regulations in place to provide guidance and mandates on how biological sample management should be handled during each stage. This can be a challenge to manage without a biorepository expert on your team.
Proper management is not only a compliance issue; it also affects the integrity of your overall results. In clinical trials, thousands and thousands of biological samples are collected frequently from many different locations. These samples need to be stored safely and with accurate tracking in place. Fully compliant management is a necessity to ensure the integrity of the trials. Otherwise, years’ worth of careful research and investment could be compromised.
Flawless pharmaceutical and biological sample management means flawless results. Your specimens will be properly handled, transported, and stored at all times. You can expect complete traceability of all samples, reliable dispatch of samples when needed, and compliant storage and transportation.
The right team will have all the proper procedures in place to achieve this, from in-house cold chain logistics services to state-of-the-art pharmaceutical cold storage. With the right partner, you can take a turnkey approach to biological sample management.
Optimal Storage Conditions
Remember: the optimal conditions for one sample will not be optimal for another. For example, certain biological samples are required to be stored in cryogenic conditions in a secure container that can maintain -150°C temperatures. Other samples may simply need to be kept in a medical refrigerator. Ideally, one storage facility can handle all your sample storage needs.
Chain of Custody and Distribution
There are clear guidelines for custody and distribution procedures of samples. The right biorepository will have standards in place to ensure these guidelines are followed closely, keeping you and your organization legally compliant.
In addition, you should have easy access to samples and be able to pull necessary information about these materials with ease. The right firm will have policies in place if and when a sample needs to be transported on short notice.
The Right Sample Management Partner
When you choose a trusted biological pharmaceutical facility for biological sample management, your team can focus on research and results. To learn more about the benefits of choosing the right team for your sample management needs, contact SciSafe.