Collection Network Solutions for Autologous Cell & Gene Therapies

We prepare apheresis centers to collect autologous source material and support ongoing, high-quality autologous collections.

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Collection Network Solutions for Autologous Cell & Gene Therapies

We prepare apheresis centers to collect autologous source material and support ongoing, high-quality autologous collections.

Managing apheresis networks for autologous cellular source material collection

Starting material consistency, quality and regulatory compliance are key components to the successful manufacture of autologous cell or gene therapies. That makes a collection network a critical part of a supply chain.

We provide onboarding for centers selected for a network, to ensure they have the correct infrastructure, capabilities, and training to collect and process for a partner’s protocol. Additionally, we conduct monitoring to ensure a network continues to supply high-quality source material while maintaining regulatory compliance.

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Setting up apheresis centers for success

One of the first steps in onboarding an apheresis center to a network is assessing its infrastructure and capabilities. Once our team has established that a center has the capabilities and quality systems in place to collect for a protocol, we begin the training process. Our training activities include:

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Curating and delivering client-required training using our optimized training methods

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Developing a therapy-specific collection manual

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Assessing center readiness and preparedness

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Providing an on-call team member to support critical events, including first collection and first shipment, in addition to subsequent events as needed

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Provide ongoing and refresher training

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Usman “Oz” Azam, Formerly President and CEO, Tmunity Therapeutics

There are great partners out there who can provide the support and training necessary to minimize the burden on apheresis centers. NMDP BioTherapies℠ is an example of an organization that has taken the lead and is efficiently building and managing these networks.”

Collection Network Management services

Our team monitors continual compliance with therapy-specific needs, even after we help onboard an apheresis network. Each team member is experienced in apheresis collection as a cellular starting material. These services include:

  • Answering questions from centers as they arise
  • Monitoring trends to provide recommendations on additional training or process changes
  • Providing an on-call team member on day of collection
  • Updating centers as needed on industry standards
  • Providing refresher training when deemed needed or at a regular cadence as requested by the client
  • Tracking key performance indicators and center changes, such as personnel and equipment
  • Assisting client quality teams in researching quality concerns and deviations
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