Access a Clinical Tissue network like no other
Lonza stands apart from other Clinical Tissue providers because of our consultative approach to procuring tissue for successful cell and gene therapy manufacturing. As a CDMO that works with tissues and cells for our clients’ programs, we understand what is needed to be successful and can work to provide a long term, stable supply of starting material for your IND-enabling studies through commercialization of your cell therapy.
Our Clinical Bone Marrow Donor Program has dedicated full-time staff, and our proprietary collection process focuses on quality collections resulting in high cell counts & viability for downstream processing.
We can leverage a large network of tissue and blood collection centers for additional clinical tissues including umbilical cord, cord blood, adipose (SVF), skin, leukopaks and mobilized apheresis collections. By having Lonza procure your tissue you can rest assured that we have complete Quality oversight of your process and our rigorous standards will support your Regulatory filing needs.
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 45,000 tissue donations over the last 25 years.
| PROGRAMS |
Why Lonza? |
Compliance with State and Federal Regulations |
| BONE MARROW ASPIRATE |
High quality bone marrow as direct service or for manufacturing at Lonza |
For all programs, Lonza TA team complies with state and federal regulations for collection, processing, storage and distribution of human tissue.
The team:
- maintains the appropriate licenses and accreditations,
- qualifies tissue recovery agencies
- writes collection protocols and submits for IRB approval
- obtains informed consent from donors
- screens donors for collections in compliance with US FDA 21 CFR Part 1271
- ships the collected material either directly to the customer or for manufacturing at Lonza.
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| ADIPOSE TISSUE |
Access to clinical adipose tissue and GMP regulatory package |
| UMBILICAL CORD BLOOD |
Qualification of collection service and GMP package |
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ADDITIONAL TISSUES AND CELLS
Starting material (tissues)
Skin tissue
Leukopaks
isolated cells
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Customized for your specific therapy and requirements |