Barkey plasmatherm C&G

The Barkey plasmatherm C&G is the standard choice for dry thawing of blood products, cryopreserved products or infusions: even, reproducible, time- and temperature-controlled

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Barkey varitherm

The Barkey varitherm is a dry thawing device for heat-inactivation of serum. Consistent, replicable and GMP conform.

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Barkey vialguard

The Barkey vialguard is a silicone grid for automated dry vial thawing with Barkey plasmatherm C&G and Barkey varitherm.

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Cell therapy is one of the fastest-growing segments in life-science. Immunotherapy approaches based on CAR-T technology are very promising to fight cancer and other diseases while activating the patients own immune system. Barkey devices provide a reliable solution to thaw cells during the entire process from collection to administration to patient (both autologous and allogenic).

Barkey products are reliable and dry thawing devices for gently thawing cells in the cryochain.
Since Barkey devcies are dry thawing devices, the risk of contamination is greatly reduced compared to open water baths.

Devices – and thus process data – can be recorded electronically during the manufacturing process using the “Barkey Logging Tool TCP” software.

The Barkey plasmatherm complies to the following

  • GMP
  • US FDA 510 (k) cleared
  • EN ISO 13485: 2016

 

Dedication to Science

Dedication to Science

Scientific research requires several conditions to get reproducible results and product consistency. De-risked thawing on the one hand and safe, even and automated thawing on the other hand are essential requirements for research and process development.

Regulatory

Regulatory

To guarantee reproducible and validatable research, which results withstand the claims of medical requirements, it is a matter of course, that the products of the Barkey Cell & Gene Line respect and fulfill the cell therapy regulatory standards. Therefore, the Barkey plasmatherm C&G is 510k cleared and the Barkey varitherm is FDA listed.

De-Risking

De-Risking

We want to ease your processes. Thus, we follow a one-fits-all approach. Products like the Barkey varitherm or the Barkey plasmatherm Cell & Gene are suitable for all kind of samples (bags, vials, bottles). The flexible water-filled heating cushions conform tightly to the samples. That allows to use the heat exchange through water but offers full contamination control since there is no direct contact with water.

Manufacturing

Manufacturing

Our goal is the development of new therapies and subsequently support the upscaling process as well as being part of the manufacturing process. Following our own high quality principles, we strive for a reliable tech transfer and applying the rules of GMP (Good Manufacturing Processes). That includes the full transfer through all steps of developing a therapy. From Research & Development to the point of Manufacturing. Of course, including manufacturing with CDMOs, CROs and CMOs.

Services

Services

To implement new devices into research or even manufacturing processes, standardized services and calibration procedures are mandatory. We know that and in order to provide the best possible services we offer:

  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • annual and preventive maintenance (PM)

by Barkey-trained Service Engineers. Reach out to our team.

Start Ups

Start Ups

We support all kind of ideas and scientific pioneers. You founded a Cell & Gene start up and are trying to find the right laboratory equipment like thawing and heating devices? We know the overwhelming number of laboratory devices and the difficulties while choosing the right products. Especially as it is mandatory to test the devices thoroughly and validate them before including them into the Standard Operation Procedures (SOPs). Feel free to contact us at any time. Our portfolio does not only includes heating and thawing devices like the Barkey plasmatherm C&G and the Barkey varitherm, but also Barkey warming centers to warm e.g. cell culture media. We would like to discuss the options in thawing your products.
Reach out to our team.
 

Cases

Cell Therapy Cases

In CAR-T Cell manufacturing processes, Barkey thawing devices typically come into use at two stations of the process: After harvesting the patient’s cells, they are cryopreserved and transported to a manufacturing plant, where they get thawed and modified. Later, during the bedside thawing right before the CAR-T cells are infused into the patient. As described the Kymriah CAR-T cell patent by Novartis refers to the usage of the Barkey plasmatherm. Also, the Barkey plasmatherm is part todays state-of-the-art R&G manufacturing facilities, where they manufacture autologous and allogenic cell therapies for clinical trials in the US, EU, and Asia.

Case: Emily Whitehead

Emily Whitehead

  • Emily failed all standard chemotherapy treatments. Her parents were told that there were no options left for her and that they had less than 48 hours to make a decision. At that time, they decided to enroll in a clinical trial.
  • In April 2012, 6-year-old cancer patient Emily (Emma) Whitehead became the first child to be enrolled in a clinical trial for CAR T-cell therapy that now treats patients with B cell with B cell cancers such as acute lymphoblastic leukemia (ALL), B cell non-Hodgkin lymphoma (NHL), and the adult disease chronic lymphocytic leukemia (CLL).
  • Emily received this experimental treatment at The Children’s Hospital of Philadelphia in April 2012 after her cancer relapsed for the second time.
  • Her cancer has been in remission since her treatment.

Barkey has been honored to be a pivotal part of Emily’s journey, and in launching this exciting new frontier of therapies that have the potential to take the entire field of medicine from simply tempering the symptoms, to curing them of diseases that previously had no cure. After her successful treatment, Emily’s parents founded the Emily Whitehead Foundation. Since then, Barkey’s cooperation with the foundation was prioritized.