CTS™ Detachable Dynabeads™ Release Buffer, 750 mL - FAQs

查看更多产品信息 CTS™ Detachable Dynabeads™ Release Buffer - FAQs (A5588302, A5588303, A5588301)

11 个常见问题解答

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.

How does the active release mechanism work for CTS Detachable Dynabeads?

CTS Detachable Dynabeads are meant to be used with the CTS Detachable Dynabeads Release Buffer that comes in a bioprocess container compatible with our CTS DynaCellect Magnetic Separation System for automated workflows.

After the isolation step, the Dynabeads-bound T cells are incubated with the CTS Detachable Dynabeads Release Buffer to actively detach the cells from the Dynabeads. The CTS Detachable Dynabeads Release Buffer contains d-biotin that outcompetes a biotin derivative on the surface of CTS Detachable Dynabeads. It is not an enzymatic reaction.

Users may then rely on the CTS DynaCellect Magnetic Separation System to magnetically separate CTS Detachable Dynabeads from target T cells so they are left with a highly pure target T cell population in the positive fraction.

Find additional tips, troubleshooting help, and resources within our Dynabeads Cell Isolation and Expansion Support Center.

Do I need to purchase any other product along with CTS Detachable Dynabeads CD3/CD28 (Cat. No. A56996) to perform the active release of the CTS Detachable Dynabeads CD3/CD28?

Yes, you would need to also purchase the CTS Detachable Dynabeads Release Buffer in order to take advantage of the active release mechanism for CTS Detachable Dynabeads CD3/CD28. The CTS Detachable Dynabeads Release Buffer contains d-biotin that outcompetes a biotin derivative on the surface of CTS Detachable Dynabeads CD3/CD28. It is not an enzymatic reaction.

After the active release of CTS Detachable Dynabeads CD3/CD28, you may use the CTS DynaCellect Magnetic Separation System to magnetically separate the CTS Detachable Dynabeads CD3/CD28 from target T cells so that you are left with a highly pure target T cell population in the positive fraction.

Find additional tips, troubleshooting help, and resources within our Dynabeads Cell Isolation and Expansion Support Center.

Are CTS Detachable Dynabeads compatible with any cell culture media?

Due to the presence of biotin in the CTS Detachable Dynabeads Release Buffer, we do not recommend using CTS Detachable Dynabeads with media that already contain high amounts of biotin, such as RPMI media. Instead, we recommend pairing with media such as our CTS OpTmizer SFM and CTS OpTmizer Pro SFM.

Note: Internal studies have shown that the biotin in the CTS Detachable Dynabeads Release Buffer does not have any impact on cell phenotype or viability.

Find additional tips, troubleshooting help, and resources within our Dynabeads Cell Isolation and Expansion Support Center.

When using CTS Detachable Dynabeads, what is the level of residual Dynabeads left after the bead removal step?

This depends on the total number of cells that you are processing in a single run and the total number of Dynabeads used. However, our large-scale studies with 10-liter volumes on the CTS DynaCellect Magnetic Separation System yielded less than 25 residual Dynabeads per 3 million cells. And with 1-liter volumes, performance was even better as we observed less than 5 residual Dynabeads per 3 million cells (again in internal studies).

As a reference point, most regulatory agencies have an unofficial minimum threshold of 100 residual beads per 3 million cells.

Find additional tips, troubleshooting help, and resources within our Dynabeads Cell Isolation and Expansion Support Center.

Can I try out CTS Detachable Dynabeads but do so manually with columns, and not with the CTS DynaCellect Magnetic Separation System?

All of our CTS Detachable Dynabeads products are intended to be used with the CTS DynaCellect Magnetic Separation System. While small DynaMag magnets can be used to assess the functionality of the product in a laboratory scale, it does not allow you to see the full benefits or accurate performance should you decide to scale up to clinical or commercial manufacturing.

Using our CTS Detachable Dynabeads without the CTS DynaCellect Magnetic Separation System is not representative of the yield and purity obtained in the automated closed system.

Find additional tips, troubleshooting help, and resources within our Dynabeads Cell Isolation and Expansion Support Center.

What is the level of support offered when using CTS Dynabeads and CTS Detachable Dynabeads in clinical trials and commercial manufacturing?

Our CTS Dynabeads and CTS Detachable Dynabeads are supported with Drug Master Files (DMFs), Regulatory Support Files (RSFs), and other traceability documentation.

We have dedicated resources from our Quality and Regulatory teams to support customers who enter into a Commercial Supply Agreement with us.

Find additional tips, troubleshooting help, and resources within our Dynabeads Cell Isolation and Expansion Support Center.