Are CTS Dynabeads and CTS Detachable Dynabeads for clinical trial and commercial manufacturing use?
Yes, CTS Dynabeads and CTS Detachable Dynabeads are GMP-grade and CTS-branded, which means that they are eligible for use in process development, clinical trials, and commercial manufacturing.
Thermo Fisher Scientific’s Cell Therapy Systems (CTS) translates to cGMP manufacturing, testing, and traceability documentation (such as Drug Master Files and Regulatory Support Files) for customer filing needs, and a proven track record of use in many clinical trials and commercialized drugs on the market.
The CTS Dynabeads portfolio, specifically, has been actively used in over 200 clinical trials in 2023 as well as in a number of FDA-approved drugs for commercial use.
Find additional tips, troubleshooting help, and resources within our Dynabeads Cell Isolation and Expansion Support Center.
Can the CTS Detachable Dynabeads Release Buffer be filtered before use?
The CTS Detachable Dynabeads Release Buffer can be filtered with a 0.2 µM PVDF filter before use. Filtration does not negatively affect product performance.
Find additional tips, troubleshooting help, and resources within our Dynabeads Cell Isolation and Expansion Support Center.
Is there a probability that the recombinant human albumin in the CTS Detachable Dynabeads Release Buffer may develop aggregates?
There is a very low probability that the CTS Detachable Dynabeads Release Buffer may develop minor albumin aggregates after agitation. However, internal studies and multiple publications have shown that albumin aggregates do not affect product quality or performance. Please refer to the Certificate of Analysis that contains a similar statement.
If desired, the product can be filtered with a 0.2 µM PVDF filter before use. Filtration does not affect product performance.
Find additional tips, troubleshooting help, and resources within our Dynabeads Cell Isolation and Expansion Support Center.
What are the shipping and storage and conditions for the CTS Detachable Dynabeads Release Buffer?
The CTS Detachable Dynabeads Release Buffer is shipped at 2-8 degrees C. We recommend storing it at 2-8 degrees C, protected from light.
Find additional tips, troubleshooting help, and resources within our Dynabeads Cell Isolation and Expansion Support Center.
What is the shelf-life for the CTS Detachable Dynabeads Release Buffer?
At the time of launch to market for the CTS Detachable Dynabeads Release Buffer in September 2023, the shelf-life was 12 months, but our plan is to extend the shelf-life to 18, 24, 36, 48, and 60 months on a rolling basis. Therefore, our expectation is that the shelf-life will be 5 years by the year 2028.
Find additional tips, troubleshooting help, and resources within our Dynabeads Cell Isolation and Expansion Support Center.
