The field of cell and gene therapies (CGT) is advancing rapidly, with an increasing number of therapies receiving approval for various conditions, ranging from rare genetic disorders to more common diseases like cancer. As the scope of treatable conditions widens, there is a parallel demand for advanced drug delivery systems that ensure these therapies are administered safely and effectively.

Among the many sessions at the recent Parenteral Drug Association Week (formerly PDA Annual Meeting) in Palm Springs, CA, several focused on advanced therapy medicinal products (e.g., cell therapies, gene therapies), biosimilars, and disruptive therapies (e.g., live biotherapeutic products). With the growth of these therapies, there is an increased need for specialized low-temperature packaging solutions, particularly for vials and syringe systems at -50^oC to ≤ -130^oC.

Cell-based therapies have emerged as a revolutionary approach in the field of regenerative medicine and as an anti-cancer therapeutic modality, offering potential treatments for a range of diseases. As the demand for cell-based therapies continues to grow, it is crucial to explore the current and future fill-finish packaging strategies to ensure the safety, efficacy, and accessibility of these therapies. Understanding the advantages and challenges associated with different modes for cell therapy packaging will allow drug manufacturers to choose a suitable system.

Cell and gene therapies are an expanding area with an expected growth rate of 24.7% over the forecast period of 2022-2030 .¹
Vial-stopper-seal combinations used as containment systems for these therapies need to maintain container closure integrity (CCI) for extended periods. Achieving CCI can be a particular challenge due to the low storage temperatures required: ultra-low (-80°C) for gene therapies and cryogenic (≤ -130°C, i.e., vapor of liquid nitrogen) for cell therapies.

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.

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.

West's Applied Research Team will be presenting two scientific posters at the upcoming International Society for Cell and Gene Therapy 2021 New Orleans Annual Meeting taking place online May 26 – 28, 2021.