variables that can impact the safety and integrity of the biologics. Therefore, they require greater care in the custody of a biobank. Due to the complexity associated with the administration of biologics and cell therapies to the patient, they experience many transactions in the chain of custody. This high volume of transactions increases the need for standardized processes to ensure the therapy remains efficacious. Based on the number of steps in the supply chain, it’s increasingly important to have safeguards in place that minimize risk and ensure the material is at the correct temperature and hasn’t experienced any excursions. Minimizing Risk While temperature maintenance remains a critical aspect of sample integrity, researchers are now looking beyond temperature and focusing on the impact of long-term storage on sample integrity. In addition, there is increased attention to the data associated with the sample’s molecular viability, well beyond just the temperature data. These include freeze-thaw cycles, time out of temperature, sample handling and manipulation, and have become integral data points associated with measuring —all sample integrity. One way to is to proactively improve operations through . It’s also important to involve resources such as quality assurance, process managers, software compliance, and validations. Improvements in process and increased transparency among key organizational roles will enable a smooth transition throughout the chain of custody. The evolution of biorepositories to biobanks has helped identify some of the necessary data points that should be analyzed when measuring sample integrity. By adhering to SOPs for biologics and cell therapies, you not only put in place procedures that ensure excellent management of biological material, but these SOPs trickle down and apply to biospecimen management as well. Whether managing high value material or a high volume of biospecimens, sample integrity is at the core of our industry. However, it is the valuable partnerships and proprietary biobanking processes, workflow, and risk mitigation tactics that truly set some biobanks’ expertise above the rest.
variables that can impact the safety and integrity of the biologics. Therefore, they require greater care in the custody of a biobank. Due to the complexity associated with the administration of biologics and cell therapies to the patient, they experience many transactions in the chain of custody. This high volume of transactions increases the need for standardized processes to ensure the therapy remains efficacious. Based on the number of steps in the supply chain, it’s increasingly important to have safeguards in place that minimize risk and ensure the material is at the correct temperature and hasn’t experienced any excursions. Minimizing Risk While temperature maintenance remains a critical aspect of sample integrity, researchers are now looking beyond temperature and focusing on the impact of long-term storage on sample integrity. In addition, there is increased attention to the data associated with the sample’s molecular viability, well beyond just the temperature data. These include freeze-thaw cycles, time out of temperature, sample handling and manipulation, and —all have become integral data points associated with measuring sample integrity. One way to is to proactively improve operations through . It’s also important to involve resources such as quality assurance, process managers, software compliance, and validations. Improvements in process and increased transparency among key organizational roles will enable a smooth transition throughout the chain of custody. The evolution of biorepositories to biobanks has helped identify some of the necessary data points that should be analyzed when measuring sample integrity. By adhering to SOPs for biologics and cell therapies, you not only put in place procedures that ensure excellent management of biological material, but these SOPs trickle down and apply to biospecimen management as well. Whether managing high value material or a high volume of biospecimens, sample integrity is at the core of our industry. However, it is the valuable partnerships and proprietary biobanking processes, workflow, and risk mitigation tactics that truly set some biobanks’ expertise above the rest.
Biobanking%20for%20Biologics%20and%20Cell%20Therapies%20All%20Biobanks%20Are%20Not%20the%20Same.docx