Why work with us?
We will 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 the tissues you need among our network of Tissue Recovery Agencies, including our bone marrow experience with over 7,000 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 before developing 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.
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.
|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.
|ADIPOSE TISSUE||Access to clinical adipose tissue and GMP regulatory package|
|UMBILICAL CORD BLOOD||Qualification of collection service and GMP package|
ADDITIONAL TISSUES AND CELLS
|Customized for your specific therapy and requirements|
Global Head of Process Development