Clinical Bone Marrow for Cell Therapy Program
Success Starts
at the Source,
the Right Tissue
Is Important
Each cell therapy program begins with tissue-derived cells, and sometimes sourcing the right tissues can be daunting. We are here to help.
Meeting the 3 key parameters for a successful program
High cell viability
>95%
High cell count >2bn TNC per collection
Commercialization experience
Avoid costly setbacks and talk to Lonza if you have any of these issues
- Low cell count or cell yield
- Repeat donor deferrals or cancellations
- Regulatory issues or quality concerns
Our bone marrow donor and collection data
Lonza’s proprietary method of bone marrow extraction results in less peripheral blood contamination & therefore more targeted therapy cells – MSCs in particular.
Our donor program limits the age to under 45yo with previous bone marrow collection history.
We have back-up donors on-site for screening & collection to reduce no-shows for important GMP collections.
Clinical bone marrow in a few months' time
We have has been one of the few providers of clinical bone marrow used in a commercial filing and product launch of a MSC cell therapy.
We have a unique, proprietary method of bone marrow collection that reduces peripheral blood contamination and results in high cell counts and viability.
We have over 25 years of experience working with human donor programs. This includes the recruitment and maintenance of donor pools, specialized 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 provide of this quality material.
Clinical bone marrow in a few months’ time
- The basics of this timeline start with any donor and IRB requirements – everything must be set up correctly from a donor eligibility and collection standpoint to allow for downstream use for each client’s clinical indication
Lonza wants to help with your clinical bone marrow needs, whether you need a primary or secondary supplier, contact us today.
Need more information?
Infographic:
GMP Tissue Source: a complex process, prone to misconceptions and pitfalls, to find the “right human tissue” that will yield the desired cell quality and quantity, and pass BLA approval
