Bridging the Gap Between Biobanks and Industry

Biospecimen Management System for Biobanks

October 28, 2021

Biospecimen acquisition in industry represents a serious challenge that slows down innovation. The number of biobanks has increased around the world due to the growing requirement of biospecimens by industry. However, the lack of connection between biobanks and industry has slowed down the possibilities to use biospecimens for testing new therapies, developing vaccines and strategies for diagnosis. Private companies face difficulties accessing high-quality specimens because they mostly originate from public sector healthcare facilities and companies have limited access to such facilities. It is important to bridge the gap between biobanks and industry so that researchers can easily access carefully processed, high-quality biospecimens to support research and development.

Pharma and biotech companies mainly procure biospecimens for research from commercial brokers who charge a fee for providing samples from biobanks. However, the use of intermediaries leads to uncertainty about sample quality and adequacy for the required experiments. Big pharma companies manage to procure samples from hospitals and in-house biobanks. They also conduct clinical trials which give them access to hospitals, doctors, and patients. Access to biosamples becomes more complicated for small biotech companies as they find it harder to establish collaborations with hospitals and biobank networks.

Challenges Faced by Industry in Obtaining Quality Samples

Commercial brokers are apprehensive about the direct interaction between a researcher and the biobank as this could lead to a loss of profits. Due to this, brokers usually do not prefer to disclose the sample source. Unfortunately, this leads to a lack of provenance information such as sample processing history, donor information and medical history, and geographic origin of samples.

Researchers need to know the identity of the source biobank. The source biobank should have obtained the appropriate license and certification as it assures sample quality and reliability. Knowing the geographic origin of samples is also important to understand the environmental, socio-economic, and genetic factors of samples. Biobanks should maintain donors’ consent for all samples stored in their biobanks and must have standard operating procedures (SOPs) in place for procuring, processing, and distributing samples. It also helps prevent the use of illegally sourced samples. Obtaining biospecimens internationally also poses a challenge of miscommunication between the source and the end-user.

Solutions

To overcome such challenges, commercial brokers can allow direct communication between the source biobanks and end-users with an agreement to ensure brokers’ commission. Companies can build their networks of biobanks to supply them with the required biospecimens. However, it is challenging to find suitable biobanks with the necessary samples in stock. Therefore, many small to medium-sized biotechs end up obtaining samples from unreliable brokers, compromising the quality and reliability of samples.

The direct connection between biobanks and industry represents a great opportunity for both sectors. Some proposals to address the challenges outlined above are:

  • Promote regulations that protect the ethical usage of biospecimens while allowing biobanks to charge a fee for sample processing.
  • Establish high standards for biosamples collection, processing and storage, with adequate documentation and data provenance to assure sample reliability.
  • Promote patients' approval to participate in private sector research by educating them about the importance of biotech and pharma health innovations.
  • Encourage industry to procure samples from biobanks that meet regulatory compliance and best practices, such as ISO 20387:2018, EU GDPR, HIPAA, and ISBER Best Practices, and follow pre-defined SOPs to maintain quality standards.

A commercial biobank can play an important role in overcoming the sample supply deficit. Commercial biobanks are experienced in interacting with industry and meeting their requirements. Unlike academic biobanks, commercial biobanks act quickly to meet administrative and regulatory requirements to provide samples to companies to facilitate their research.

How a Biospecimen Management System Can Help Biobanks Maintain Data Provenance & Maintain High-quality Samples

Companies can rely on biobanks that use a Laboratory Information Management System (LIMS) for managing data and standardizing their operations. A LIMS effectively manages samples and associated data to facilitate their tracking through sample acquisition, collection, preparation, storage, testing, analysis, and distribution. It helps in safeguarding data by assigning role-based, secure data access to authorized users. A biospecimen management system, also known as a biobanking LIMS, helps biobanks manage sample genealogy, track sample locations, and manage the shipment of samples when working with collaborators. It maintains a chain of custody to regulate the internal or external transfer of biospecimens from one custodian to another.

A biospecimen management system manages standard operating procedures (SOPs) and controls access to confidential documents, thus ensuring data security. It records details such as training details, qualifications, and competency of each staff involved in biobanking activities. Furthermore, a LIMS helps biobanks follow regulatory guidelines such as ISO 20387, HIPAA, EU GDPR, and 21 CFR Part 11.

A LIMS enables commercial biobanks to publish their sample collections along with detailed sample information on a personalized web catalog. Researchers from industry can easily find samples of their interest on the web catalog, place an order for the samples they need, and track the status of their requests.

Conclusion

Biobanks are responsible for providing high-quality, well-documented biosamples to industry to facilitate the development of new drugs, therapies, and diagnostic products for improving patient care. Pharmaceutical and biotech companies should procure biospecimens from biobanks that maintain strict quality and ethical standards and provide reliable data provenance information. A biospecimen management system is a secure and reliable system for collecting, storing, processing, analyzing, and reporting all types of biobank data. It helps biobanks securely manage data, streamline workflows, comply with regulations, and follow sample management best practices.


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