How OpenSpecimen Can Help in Building a Translational Research Biobank?

Introduction

As technology and informatic expanded, scientific research has moved from laboratory research to translational research. We are in an era where clinicians, researchers, and patients collaborate to learn about diseases and provide patient-specific treatment solutions.

For the advancement of translational research, many large institutions and hospitals are focusing on building biobanks. Recently the COVID19 pandemic restated the importance of quality annotated biospecimens provided by biobanks. 

Because of its configurable nature and powerful reporting tool, OpenSpecimen is used by many translational research biobanks. Below are some examples:   

  1. Fred Hutch Cancer Center: Cancer, HIV/AIDS, COVID19 research 
  2. Victorian Cancer Biobank: Cancer research
  3. PRECISE network: Pregnancy disorder research in African countries
  4. Johns Hopkins University: Multiple clinical research studies 
  5. FIND Diagnostics: Major diseases affecting the world’s poorest populations 

This article will take you through various biobanking operations specific to translational research and discuss how OpenSpecimen can help manage your collections. It will cover: 

  • Planning 
  • SOP Creation 
  • Biobank Staff Training
  • Post-Collection Processing
  • Disaster Preparedness
  • Sustainability 

Planning

Before starting a new biobank, it is essential to understand its goals. For example, whether the biobank is a population-based or a disease-specific biobank. Based on the biobank’s goals, the biobank team should work on:

  • Donor criteria, e.g., age, gender, disease type, etc. 
  • Collection and processing protocols 
  • Biospecimen storage requirements 
  • Pre-analytical data collection needs 
  • The long term monitoring requirements

Initial planning is vital for a biobank. Using OpenSpecimen, you can plan the collection protocol in detail. You can apply validations to ensure correct data is collected e.g. 

  • Participant age at the time of registration should be more than 18 years
  • Only male participant registrations are allowed
  • ‘Male’ participant clinical diagnoses should not be anything but ‘Adenolymphoma’.

SOP Creation 

It is essential to have consistent specimen handling processes to ensure high-quality specimens. A biobank might have various departments or sites that handle different processes; for example, one team might only collect specimens, and the other team processes them. Hence, it is essential to have an SOP to document each specimen collection, processing, and storage step. 

It is also necessary that these SOPs are annually updated, and all the versions are maintained for reference. OpenSpecimen allows you to define study calendars and an SOP for each study. 

Training

Training is as essential as SOP adherence to maximize sample integrity. Uniform staff training is crucial, especially in the case of multi-site biobanks, where variations in biobanking operations can happen due to infrastructure changes. Some of the critical factors that biobankers should focus on for staff training are:    

  • Including super-trainer: The super-trainer will ensure the uniform training of the new staff across biobank sites.     
  • Web-based training modules: These can also be helpful for multi-site training, providing continuous support and information about SOP updates.   
  • Call center: Call centers can help provide remote online support, where end-users can promptly answer their queries by the appropriate personnel.  
  • Dry runs: Dry runs can be executed as a part of onboarding new collection sites to ensure the process flows smoothly through shipment before collection.

OpenSpecimen helps you track user training as per local needs. E.g., training details such as year of training, certifications, and so on. 

Post-Collection Processing 

After the biospecimens are collected, they are processed to ensure stability. The processing steps and criteria vary for each specimen. To maintain high-quality biospecimens, it is crucial to document these steps, including any deviations. 

OpenSpecimen tracks the end-to-end life cycle of the biospecimens, i.e., from collection to distribution. Each user action performed in the system (add/edit/update/delete) is recorded with date and time.   

In modern biobanks, robotics play an important role by reducing costs and minimizing manual errors in specimen processing. OpenSpecimen provides integration support to pull data in the LIMS automatically. The University of Maryland School of Medicine has been using OpenSpecimen since 2017, along with integration with Hamilton BiOS for robotics-based automated storage management.

Even though all standardization processes are followed, there might be differences in data from two different biobanks. The organizations like CAP (College of American Pathologists) provide requirements for biospecimen processing. The biobanks should invest time in getting accreditation by such organizations. This ensures standardization of biospecimen processing and thus researchers’ faith in the biobank. Read how OpenSpecimen helped the University of California Davis achieve CAP accreditation.

Disaster Preparedness

Any events that can hinder biobank operations should be addressed while setting up a biobank—for example, natural disasters such as floods, earthquakes, etc., power outages, and fires. 

There might be some unexpected occurrences like the COVID-19 pandemic. It badly affected specimen collection and processing in biobanks. Hence it is crucial to have a disaster management team handle such unforeseen circumstances. 

ISBER recommends that biobanks have emergency management and a disaster contingency plan. A crisis management team must identify and assess risks specific to each biobank and create a risk response. 

Sustainability

The sustainability of a biobank is directly related to its efficiency. The more specimens are requested from a biobank, the more financial aid it can receive. To keep a biobank running in the long term, it is essential to assess the financial costs for the distribution of samples accurately. Also, planning to aid in the operational efficiency of a biobank is critical. It includes: 

  • Input efficiency: Patient enrollment and biospecimen accrual
  • Internal efficiency: optimizing processing, balancing resources to support retrospective questions while not storing beyond what is anticipated to be useful 
  • Offering more data elements: like records of pre-analytic variables 

OpenSpecimen’s web-based SpecimenCatalog helps biobanks publicize their biospecimen collections and maximize the use of their specimens. 

Conclusion

Biobanks are crucial for translation research. For building a successful biobank, initial planning is essential. Maintaining SOPs, uniform staff training, and biobank accreditation assure quality annotated biospecimens. A good LIMS can help – collect and track biospecimen and participant-related data.  

The LIMS usage can vary for each biobank. Hence it is important that the LIMS is customizable and address the biobank needs. E.g., OpenSpecimen provided a mobile application with an offline data entry mode for data collection in remote areas for the PRECISE study (Africa). 

The biobanks should also focus on a comprehensive disaster management plan. Maximizing biospecimen usage is vital to make the biobank sustainable in the long term.  

Reference

https://www.frontiersin.org/articles/10.3389/fpubh.2020.00362/full

 

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