The main needs of our customers can be summarized into four categories: identifying human tissue by establishing the appropriate source, organizing logistics including donor consent and quality measures, delivering the appropriate tissues each step of the way and regulatory support to meet current requirements.
Establish an appropriate source for the 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.
GMP quality tissue sourcing to meet unique customer specifications and regulatory requirements.
Ongoing regulatory support for your cell therapy product lifecycle, all the way through to commercialization.
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 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 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.
Each program is built to accommodate our client’ unique requirements.
Our extensive experience includes access to a qualified network of Tissue Recovery Agencies, through our Lonza Bioscience activities who obtain bone marrow, blood, apheresis products, cord blood, skin, adipose and other tissues and other organs. Our own bone marrow donor program has been established for over 20 years with more than 6000 donors.
Our logistics support involves agency approvals, donor screening and testing, medical director donor eligibility, tissue collection, required documentation and qualified shipping are defined with seamless workflows at Lonza.
Our Regulatory Services are instrumental to these activities to enable us to de-risk your entire process.
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.
Global Head of Process Development