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.
Identify human tissue
Establish an appropriate source for desired cell type with robust quality tissue to harmonize with manufacturing platforms
Develop donor consent, global logistics, quality measures, and regulatory pathway for your cell therapy use
Deliver research, clinical and commercial tissue
GMP quality tissue sourcing to meet unique customer specifications and regulatory requirements
Ongoing regulatory partnership for your cell therapy product lifecycle through commercialization
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.
Each program is built to accommodate client's custom needs.
We are experienced – has its own bone marrow donor program (20 yrs, over 6000 donors) and – has qualified a network of Tissue Recovery Agencies through our Lonza Bioscience activities to obtain bone marrow, blood, apheresis products, cord blood, skin, adipose and other tissues and other organs.
Logistics – Agency approvals, donor screening and testing, medical director donor eligibility, tissue collection, required documentation, and qualified shipping are defined with seamless workflows at Lonza.
Regulatory Services are instrumental to these activities – we are able to de-risk through experience.
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 the 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.