Global Integrated Solution for cell therapy clinical development and commercialization

Regulatory Compliance

through our quality systems to meet strict FDA criteria

Customized Storage & Packaging Configurations

for optimal material management

Reliable Chain of Custody

to ensure material integrity and viability throughout transportation

Reliable Chain of Custody

Due to the complexity associated with the administration of biologics to the patient, they experience many transactions in the chain of custody. This high volume of transactions during storage, packaging, and transportation of the material increases the need for standardized processes to ensure it remains efficacious. As the leader in managing critical biological material, we ensure a seamless workflow which connects the sponsor, bio-manufacturer, clinical center, and patient into a well-coordinated chain of custody.

Securing Your Material

The complex, live structure of biological material is highly sensitive to environmental changes and thus, requires a comprehensive supply chain. This type of material not only necessitates temperature controlled storage and handling, it also must be closely monitored to ensure that material maintains its stability and viability. As the leader in managing critical biological material, we provide our customers with customized solutions to store, package, and transport their valuable material. Through our risk controlled systems we monitor and track material to ensure that the correct temperature is maintained throughout the chain of custody. A record of this information is captured using our data management systems and provided to our customers upon request. Additionally, we are able to receive material under quarantine from the point of manufacture and maintain material in a non-released status.

Customized Storage & Packaging Configurations

Since biologically derived substances are administered to the patient from an external environment there are many variables that can impact the safety and integrity of the biologics. Therefore, they require greater care in the custody of a biobank. Upon arrival at our facility, we can freeze biological material according to manufacturer specifications, and store it under current Good Manufacturing Practices (cGMP) compliant conditions. Our state-of-the-art infrastructure and SOPs allow us to develop customized storage & packaging configurations for a multitude of biologics, including monoclonal antibodies and vaccines.

Understanding Risk:
How to Manage High Value Biologics

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 your irreplaceable, high value product such as cell-based drugs and biological material, dictates planning for the full continuum of risk.

Supporting Services