The foundation and starting material of cellular therapies is the tissue, whether it is for allogeneic or autologous cell therapy.

Navigating through the complexities of tissue sourcing and applicable regulatory guidelines to obtain clinical and commercial starting material can be very challenging. Your requirements may also change during development or manufacturing, as your therapy progresses towards commercialization.

The ability to leverage the experience of an integrated CDMO partner who offers customized tissue acquisition services removes these hurdles and will place you in a significantly better position to reach your cell therapy development goals faster.


All you need is...

We grouped the key needs of our customers into four categories: identifying human tissue by establishing the appropriate source, organizing the logistics including donor consent and quality measures, delivering the appropriate tissues each step of the way and regulatory support ensuring you meet current requirements. 

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To introduce a workflow to your sourcing

We'll start with a discussion and Q&A with you to identify your human tissue sourcing needs, current and future. On this basis, we will evaluate the availability of your need among the network we have built of Tissue Recovery Agencies, including our bone marrow experience with over 6,000 donors. Donor programs are built specifically for each client where intended use is key. Donor consent and regulatory services are instrumental to these activities. Our dedicated teams will advise you on how to fully de-risk this process. We'll then develop logistics, quality and the regulatory pathway for use of the tissue. Finally, we deliver to development or manufacturing and can provide post-donation regulatory support.

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Access a network like no other

Our in-house Bone Marrow Donor program has dedicated full-time staff, with an emphasis on procuring tissue for the cell and gene therapy manufacturing, by leveraging a large network of tissue centers.

We have experience in meeting human cell, tissues, and cellular and tissue based products (HCT/P) regulations in the US, and have maintained  accreditation from American Association of Tissue Bank (AATB).

Our unique custom services are developed to meet customer specification and global regulatory requirements for process development, clinical manufacturing, and commercial manufacturing.

We currently supply over 100 research and GMP samples per month and have supported nearly 40,000 tissue donations over the last 20 years.

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Why choose us?

  • Access to a distinguished company with deep heritage and 20+ years of tissue acquisition services
     
  • Dedicated full-time staff with an emphasis on procuring tissue for cell and gene therapy by leveraging a large network of tissue centers
  • Experience in meeting human cell, tissues, and cellular and tissue based products (HCT/P) regulations in the US, and maintained  accreditation from American Association of Tissue Bank (AATB

  • Unique custom services developed to meet customer specifications and global regulatory requirements for GMP tissue, process development, clinical and commercial manufacturing

  • Experience providing 1200+ research and GMP samples / year

  • Integrated development and manufacturing capabilities from one company, under one quality system

Our dedicated teams are ready to start planning your tissue acquisition strategy.


Complete the form below to discuss your tissue sourcing and acquisition needs with our experts and we will be in touch.

 

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