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With the May 21, 2019 meeting to review the FDA draft guidance governing 503B compounding pharmacies, it has become evident that sterility of drugs produced at such facilities is a major focus of the U.S. Food and Drug Administration (FDA).<sup>1</sup> The meeting discussed the importance of qualifying container closure systems and was aimed at providing more context on what compounding pharmacies need to do.
Why is meeting customer needs no longer enough? In an expanding global economy with international competition, meeting customer needs is simply not enough. Meeting customer needs leads to customer satisfaction but does not lead to customer loyalty, which is what keeps companies in business.
With the growing importance of <strong>gene and cell therapies</strong>, storage of <strong>vial containment systems</strong> at ultra-low temperature (-80°C) and cryogenic temperature (vapor of liquid nitrogen, i.e., -130<sup>o</sup>C to -180°C) is more common. The primary consideration for storage at such temperatures is that the <strong>vial system</strong> can maintain <strong>container closure integrity </strong>(CCI) necessary for the <strong>drug product</strong>. There are two other considerations for the vial system, considerations more critical at such temperatures than at room temperature – proper filling and proper assembly. These have been discussed in two recent publications by West scientists:<br /><br />- <em>Volumetric Capacity of Daikyo Crystal Zenith® Vials Stored in Freezing Conditons </em>(Technical Report CZ TR 2022-039)<br />- <em>Potential Over-Pressurization Issues with Ultra-Low Temperature or Cryogenic Storage of Improperly Sealed Vial/Stopper Primary Package Systems </em>(Technical Service Bulletin TSB 2020-072)<br />
The number of biologic drug products marketed with an injection device has approximately quadrupled over the last decade. The growth in these drug therapies has been driven by several factors including new, self-administered therapies for chronic conditions such as rheumatoid arthritis and autoimmune diseases. In addition, injectable therapy is now being considered as a treatment for more conditions, including asthma and cholesterol problems.
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.
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