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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.
Dimethyl sulfoxide (DMSO) is a common ingredient in cryopreservation media. In the literature, DMSO has been noted to be incompatible with polycarbonate as bisphenol A (BPA) (an endocrine disrupter) is a possible extractable – a toxicological concern even in low concentrations. Understanding this, West undertook examining the interaction of cell media and different percentage DMSO solutions with VAs.
West used microscopy and gas chromatography–mass spectrometry (GC/MS) extractable techniques to analyze the effects of DMSO in concentrations typically used in cryopreservation media (≤ 15%). As expected, VAs showed dramatic visual effects via microscopy with as little as one minute of exposure to 100% DMSO, but no visual effects were observed in VAs exposed to 10% DMSO, 15% DMSO, or Cryostor® CS10 media out to 60 minutes. Furthermore, extractables studies suggest VA exposure to low percentage concentrations of DMSO (10% DMSO and simulated 15% DMSO) up to 60 minutes do not result in BPA as an extractable.
Vented (VVAs) and non-vented VAs were also tested for deliverable and residual volume performance in comparison to a 27 gauge needle. VVAs and VAs performed comparably for both low (1 cP) and high (15 cP) viscosity solutions. Furthermore, West compared the performance of the VVA versus a 27 gauge needle for the retrieval of suspension CD34+ cells (HSCs) and adherent human mesenchymal stem cells (hMSCs) from 2mL Daikyo Crystal Zenith® vials. West’s VVAs were capable of volume and cell recovery comparable to that of a 27 gauge needle and syringe across four different operators and both cell types.
These results are described in a recent Technical Report, Evaluation of West’s Vial Adapters for Cell Therapy Applications, Technical Report 2020/224. West’s VAs are compatible with DMSO-containing cell therapy medias and perform as well as needles for withdrawal of cell solutions as tested. For more, visit the Knowledge Center or contact a Technical Customer Support (TCS) representative.
Rx Only
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
Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd. Daikyo Crystal Zenith technology is licensed from Daikyo Seiko, Ltd.
Vial Adapter™ and Vented Vial Adapter™ are trademarks of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
Cryostor® is a registered trademark of BioLife Solutions, Inc.
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.
Vial adapters are a cost-effective solution for the safe and rapid reconstitution and transfer of drug products. 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.
Cancer affects all of us, whether we are a patient, a family member, a friend, or a colleague of someone fighting cancer. Working together, we can increase our understanding of this disease and support the groundbreaking research that is ongoing in the fight against cancer.
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 therapies offer a powerful new approach to treat cancer and other serious conditions. The manufacture and supply of these therapies is complex – to address the short shelf lives of such living products, storage and shipping is done at cryogenic temperatures (liquid nitrogen, approximately -180<sup>o</sup>C). A challenge is selecting the right container system.<br />
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