Maintaining sterility, reducing open manipulations, and standardizing techniques are constant challenges in cell processing and cryopreservation workflows. The OriGen Biomedical® Cell Connect® Accessory is designed to help laboratories efficiently transfer stem cells and freezing media into up to four CryoStore Freezing Bags at once, with flexibility for spike, luer, or sterile‑welded connections to fit into existing GMP processes.

Configuration and Design

The Cell Connect Accessory is a single‑use fluid-transfer accessory that connects multiple cell sources and freezing media to up to four CryoStore Freezing Bags simultaneously, helping to streamline aliquoting and reduce hands‑on time per batch. Two configuration designs accommodate different laboratory setups:

• CC1: includes two spikes leading to a 3‑way stopcock, 60 mL syringe, and a needle‑free valve that distributes to four male luers with approximately 70 cm of SCD‑weldable PVC tubing and pinch clamps.
• CC2: provides one spike and one male luer leading to a 3‑way stopcock, 60 mL syringe, and a needle‑free valve that distributes to four male luers with approximately 70 cm of SCD‑weldable PVC tubing and pinch clamps to support alternative source container connections while maintaining a closed, weldable path.

Both configurations arrive sterile in individual Tyvek® pouches and are intended for single use in qualified laboratory environments.

In a typical setup, technicians attach cell sources and freezing media to the spikes or luer connection, then connect our CryoStore Freezing Bags via the downstream male luers. Pinch clamps control flow to each bag, and unused tubes can be sealed or clamped after filling to minimize cell loss and maintain traceability. This approach reduces the number of separate transfers, connections, and seals, which can simplify validation and cut down processing time.

Closed-System Processing

A key advantage of the Cell Connect Accessory is its PVC tubing, which supports sterile docking and sterile welding to help establish a closed‑system workflow around our CryoStore Freezing Bags. By integrating weldable tubing with spike and luer options, laboratories can connect to cell sources, freezing media, and bag manifolds without repeatedly opening the system, which can reduce contamination risk in cleanroom space for every manipulation.

The needle‑free valve (NFV) design eliminates the need for needles in the transfer set, supporting institutional sharps‑injury prevention and reducing the risk of needlestick injuries for laboratory personnel. When paired with CryoStore Freezing Bags that offer luer‑actuated needle‑free injection ports in compatible tube sets, the entire workflow from loading freezing media to filling and sampling can be designed to operate without needles while maintaining aseptic access, so it’s safer for the user.

CryoStore Freezing Bag Compatibility

CryoStore Freezing Bags are the intended bag platform used with the Cell Connect Accessory in this workflow. CryoStore Freezing Bags are FDA 510(k)-cleared, CE-marked, and have been validated at institutions worldwide for freezing blood components and cell products. The bags are made from robust EVA film with hermetically sealed spike ports and are qualified for cryogenic use down to −196 °C, supporting long‑term storage in liquid nitrogen environments.

A matte finish on both sides of the bag prevents the film from sticking to itself while maintaining sample visibility.​ CryoStore bags are available for recommended freeze volumes from 10 to 450 mL, with a range of tubing configurations, including SCD‑weldable sets, male and female luers, and needle‑free ports that integrate directly with Cell Connect Accessory workflows. Donor tubes are intentionally positioned at the bag corner to facilitate de-bubbling and heat sealing, supporting consistent aliquot use and sample traceability.

Performance and Validation

CryoStore Freezing Bags have undergone extensive validation for extreme temperature performance, including thermal shock, long‑term freezing, and repeated freeze–thaw cycles without evidence of cracks, leaks, or material degradation under the tested conditions. Additional testing has evaluated bioburden, endotoxin levels, gamma sterilization resistance, and biocompatibility per ISO 10993, supporting their use as primary containers for blood components and cell products in regulated environments. For more detailed validation data, technical documents, and white papers, customers can log in to the OriGen Biomedical Client Dashboard to explore additional resources.

Manufacturing and Quality

Cell Connect Accessories include a Certificate of Conformance and carry CE marking, aligning with expectations for traceability and lot‑level documentation in GMP‑governed facilities. OriGen Biomedical maintains ISO 13485:2016 certification and MDSAP participation, and manufactures all products in accordance with Good Manufacturing Practice guidelines. CryoStore Freezing Bags comply with ISO 13485, US FDA 21 CFR 820, MDSAP, and GMP standards.

Conclusion

Together, the Cell Connect Accessory and CryoStore Freezing Bags offer a practical way to move from open, vial‑based aliquoting to a closed, weldable bag‑based workflow that supports sterility, operator safety, and consistent product handling across batches. For the full workflow white paper and additional best‑practice guidance, visit the Client Dashboard for technical documents, validation summaries, and recommended handling protocols. For a closer look at the dashboard, its benefits, and tips for navigating this exclusive customer portal, see the blog post “Maximizing Your Access to Resources: A Guide to the Client Dashboard.”