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Administration of cell therapy drug products requires the delivery of cell suspensions without loss of function or viability. Cells must be transferred aseptically from their original container closure system to the administration system by infusion. However, the common transfer practice of using needles and syringes to pierce vial stoppers to retrieve contents poses a risk, namely needle-stick injury to clinicians.
West has a solution – polycarbonate-based, needle-free, vial adapters (VAs) that are compatible with vials made of either glass or Daikyo Crystal Zenith® cyclic olefin polymer (a high-quality engineered polymer). VAs enable aseptic transfer from the vial through a Luer-lock connection. Vented VAs allow sterile filtration of air to replace liquid as it is withdrawn, avoiding pressure differentials. Use of VAs is convenient and reduces risk of needle-stick injuries. Moreover, VAs provide for cell function and viability. This was the subject of a recent report by West scientists: Evaluation of West’s Vial Adapters for Cell Therapy Applications, Technical Report 2020/224. It was shown that polycarbonate is compatible with DMSO-based cell media. And in collaboration with scientists at Loughborough University (a major national center in the UK for innovative and process-oriented regenerative medicinal research), retention of both function and viability was demonstrated with two types of stem cells, mesenchymal and hematopoietic. After freeze/thaw processing, cell recovery and cell viability were excellent and provided equivalent results whether stem cells were withdrawn by VAs or the standard method using needles. Performance was independent of operator – indicating ease of VA use.
VAs were demonstrated to be a suitable option for cell therapy drug products and were reported to be preferred in handling over the commonly used needles. They are an important aspect of West’s overall support for cell therapy drug products. For more on how West can help visit our Vial Adapters webpage or contact an Account Manager or Technical Customer Support representative.
Disclaimer:
Vial Adapters are 510(k) cleared by the United States Food and Drug Administration and carry the CE mark (0344). Products are shown for INFORMATION purposes only and may not be approved for marketing in specific regions. Distribution and use are subject to applicable regulatory approvals and requirements for medical devices. Please contact your West Pharmaceutical Services, Inc. (West) representative for product availability. Important product information, safety and warnings are included at: https://www.westpharma.com/products/vial-adapter-systems/vial-adapters.
As cell therapies are making their way to the market, safe and efficient transfer/delivery presents a challenge. Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. To address this, West has evaluated the suitability of its needle-free polycarbonate vial adapters (VAs) for withdrawing contents from vials from both a compatibility and performance standpoint.
Vial adapters are easy to use and pose less risk of needlestick injury than traditional syringe and needle manipulation. They not only provide needle-free transfer of liquid for reconstitution, but also enable consistent withdrawal of drug product from a vial. By providing such consistent withdrawal, the use of vial adapters can aid in reducing the amount of required overfill (extra drug product in a vial to address the fact that not all drug product can be removed), which may result in cost savings.
It is an exciting time to be in the Cell and Gene therapy industry. The astounding growth and development we have witnessed in the cell & gene therapy industry over the last decade is bringing life-changing therapies to the patients who have been so anxiously awaiting them. <br /><br />At the same time, as with any new drug class, challenges that may not have been considered during the drug development phase may suddenly show up and stand in the way of overcoming that last hurdle: Packaging and delivering your precious new molecule to the patient.
Cell-based therapies are a unique solution to a variety of health issues, and can make an undeniable impact on a person’s life. But with this unique solution comes several challenges, including packaging issues associated with cryogenic storage, inspection, and extraction of the drug product. Selecting the right packaging for the cell line can mitigate risks of breakage and cell death, enhance your ability to conduct crucial stability and integrity testing, and enable ease of transition during each phase of development.
Gene and cell therapies require cryo storage – approximately -80<sup>o</sup>C for genes, and approximately -180<sup>o</sup>C (i.e., vapor of liquid nitrogen) for cells. This requirement places a very high demand on the packaging to provide both good container closure integrity (CCI) and preservation of drug product viability.
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