Over the past decade, a wave of scientific advances and new technologies have made significant impacts on how medicines are discovered. The drive towards personalized medicine has led to an increased understanding of the molecular and genetic bases of disease. As a result of this increased knowledge, the life sciences industry is shifting its focus from small molecule medicine to biologic medicine, resulting in increased use of biologics in clinical trials and R&D efforts.
The requirements to manage this type of material are capital intensive, demand expert handling, and must meet strict regulatory criteria. In this blog we’ll explore some of the important factors to consider when entrusting a service-provider with your highly valuable biological material.
Factor 1: Comprehensive Vetting Process
Prior to making any commitment to a service provider, it’s important that you properly vet them to ensure they are capable of providing the services you require. Below are a few suggestions on how to do so:
- On-site Visit: If possible, plan to visit the provider’s facility. This will give you the opportunity to familiarize yourself with the site.
- Quality/Compliance Audit: A quality/compliance audit is used to ensure that policies, procedures and trained staff are in place to meet your needs.
- Quality Technical Agreement: By putting this service level agreement in place, it will ensure the quality and operation aspects that you require are met.
- Financial Background Check: It is very important that your service provider is financially stable before you trust them to manage your highly valuable material.
Factor 2: Temperature Monitoring
One of the many differences between small molecules and biologics is that biologics have a complex, live structure and are highly sensitive to environmental changes. This type of material not only requires temperature controlled storage and handling, it also must be closely monitored to ensure that material maintains its stability and viability. Ultra cold storage units should be monitored for both temperature and humidity, and include redundant compressors to prevent temperature excursions if the primary compressor should fail.
Factor 3: Regulatory Compliance
Due to the complexity associated with the administration of biologics to the patient, they experience many transactions in the clinical supply chain. This high volume of transactions during storage, packaging, and transportation of the material increases the need for standardized processes to ensure it remains efficacious. The foundation of these processes lies in regulatory guidelines instated by governing bodies such as the FDA and EMA.
Following current Good Manufacturing Practices (cGMP) is also very important. GMP refers to the Good Manufacturing Practice Regulations published by the FDA under the Federal Food, Drug, and Cosmetic Act. These regulations are meant to guide companies in the production of safe and effective drugs. The regulations outlined in the GMPs are the minimum requirements necessary to ensure safe and effective products.
Factor 4: Risk Management
The management of risk is part of all business operations; however to those in the life sciences industry that are manufacturing biological material, risk mitigation is of utmost importance. The costly nature of irreplaceable biological samples / cell lines and high value products such as cell-based drugs, and biological active pharmaceutical ingredient (biologic API) dictates planning for the full continuum of risk.
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