Cell Therapy Tissue Acquisition | Tissue Sourcing Services

20+ Years' Experience

We have extensive experience in tissue sourcing and acquisition services.

Dedicated Full-time Teams

Our dedicated team has the extensive knowledge and experience required to manage the complexity of procuring tissue for cell and gene therapy.

1200+ Samples Annually

We provide more than 1200 research and GMP samples every year.

Our Approach

We have both standard offerings and custom capabilities to fulfill your human tissue sourcing needs now, and in the future. Depending on if you are filing your Investigational New Drug (IND) application and are looking for your first clinical tissue sourcing partner or moving into a new trial phase and need multiple suppliers to help with logistics and demand, we are here to help.

We will start with a discussion and Q&A with you to identify your human tissue sourcing requirements. Depending on your needs we will recommend one of our standard offerings like:

Clinical Bone Marrow
Leukopaks and GMP PBMCs
Clinical Tissue – Skin and Adipose
Clinical Umbilical Cords and Cord Blood

If you require something entirely new we can help set-up new tissue sources and Institutional Review Board (IRB) – approved programs with informed consent documentation for your long-term program needs.

As with both our standard offerings and general clinical tissue procurement capabilities 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.

We can help – contact us about your project today

Clinical Bone Marrow

Meeting the three key parameters for success:

High cell viability >95%
High cell count >2 B TNC per collection on average
Commercialization experience

We are one of the few providers of clinical bone marrow used in a commercial launch of a MSC cell therapy. Our proprietary method of bone marrow collection reduces peripheral blood contamination and results in higher cell counts. With >25 years of experience working with human donor programs we understand recruitment and maintenance of donor pools, testing needs, and important record retention for regulatory filings. In addition, our knowledge of GMP manufacturing raw material requirements make us uniquely suited to be the market’s top provider of this quality material.

Avoid costly setbacks and talk to us if you have any of these issues:

Low cell count or cell yield
Repeat donor deferrals or cancellations
Regulatory issues or quality concerns

Clinical Leukopaks and GMP PBMCs

Having readily available starting material to create batches for patients when they are needed is an important aspect of your supply chain to consider. Lonza works with multiple collection sites for allogeneic donor material for leukopaks and mobilized leukopaks.

For this offering concept we can procure either fresh or cryopreserved leukopaks for downstream CAR-T/NK manufacturing or for an easy off-the-shelf option of GMP PBMCs we can offer D1 processing of leukopaks into cryopreserved vials or bags.

We can streamline your contracting and quality needs into one end-to-end supply by contracting with us to supply your apheresis material and handle your downstream manufacturing. No more coordination between your collection sites, making sure you have back-ups available, and auditing multiple groups to manage your allogeneic starting material supply.

Learn more about this service

Clinical Tissue

Cell therapies start with raw material, documentation and donor eligibility for the specific regulatory authority. This includes the use of GMP or clinical tissue and the corresponding IRB-approved programs with the correct Informed Consent for the downstream clinical indication.

Depending on your specific needs; skin, adipose, umbilical cord/blood or another tissue type altogether, we have an extensive network and decades of regulatory experience to help your program succeed.

Some tissue are more readily available than others and we encourage you to explore GMP tissue requests with Lonza as early as possible to set up a reliable source for your starting master cell bank or allogeneic therapy.

We can coordinate your tissue collection program with the understanding that this material can take you through to your commercialization phase saving you time and money in the long run.

Custom Capabilities

Each cell and gene therapy project begins with tissue-derived cells and for every customer that develops such therapies, sourcing the tissues can be daunting. Often, they are looking to suppliers for guidance. These tissues must be obtained from an appropriate source, they must be sourced ethically with informed consent from the donor. In addition, the clinical tissues must meet certain criteria and specifications. For the FDA and other regulatory governing bodies, safety is of utmost importance when it comes to cell and gene therapies and for good reason. Thus, there are stringent safety and testing requirements for tissues that will be used in clinical trials and for commercial manufacturing.

Tissue material is key to any cell therapy, as it determines the quality of the final product.

Donor eligibility 1271 CFR (code of federal regulations), including donor consent for the intended indication and phase, and donor testing, can change based on new regulatory requirements e.g COVID testing, Zika testing, or advanced copy number assays for infectious disease screening, etc.

Global regulatory requirements can be similar but can also have varied needs like specific post collection testing under certain clinical indications or trial circumstances.

It is the Sponsor’s responsibility to articulate how these requirements are met, the risk assessment, the competency determination, satisfactory licenses, records maintained for 30 years.

We can help you

Our Lonza Bioscience group includes Cell Discovery Solutions where you can find a variety of cell types including primary and stem cells from a huge inventory of different donors and includes related growth and differentiation media for best use options. Lots of our Bioscience customers become CGT customers as they move their programs along their clinical pipeline.

We can support your early discovery to pre-clinical work through our Bioscience business unit portfolio and transition you to GMP requirements through our CGT business unit. We understand needs for clinical manufacturing and can set you up for success with your tissue acquisition program whether you utilize Lonza for downstream manufacturing or not. We of course prefer that you do, but understand every project is unique and we want to support you in every way we can.

Tissues must be obtained ethically from an appropriate source, with the appropriate informed consent documentation.
There are stringent safety and testing requirements for tissues that will be used in clinical trials and for commercial manufacturing.
Each Cell Therapy program begins with tissue-derived cells and sometimes sourcing the right tissues can be daunting.

We are here to help!