Cell and gene therapies may be considered novel by the general public today, but they are on the path to dramatically improve the lives of those with chronic conditions and cancers. While a handful of therapies have bene commercialized, hundreds of these therapies are currently being administered to patients in clinical trials, and the FDA is likely to approve nearly two dozen more by 2023.
Although the companies that develop cell and gene therapies are required to follow US and international guidelines for pharmaceutical products – rules created by the FDA and EMA – the logistics organizations that support these companies are not held to the same standards. Not yet, anyway. And this is critical because the development and distribution of these therapies depend heavily on logistics support: These therapies make a round trip between the point of care, the manufacturing facility, and then back again during the production and delivery process. Each shipping journey puts the product at great risk, because even the slightest temperature deviation can render the therapy unusable.
So how can a pharmaceutical company such as Novartis or Gilead be sure that its supply chain provider is handling its products with the utmost care?
This is where the ISO, the International Organization for Standardization, comes into play – and why Cryoport’s recent ISO 9001:2015 certification is so important. The ISO has published over 23,000 standards, covering all aspects of technology and manufacturing, established by nearly 800 technical committees.
An ISO certification is a seal of approval, proof that the organization meets or exceeds a set of global standards defined by international experts. It also provides evidence of the company's credibility as well as confidence that the company follows the most stringent requirements required by the standard. Certified companies are regularly audited to ensure that the standards are maintained and, if an accredited organization fails to maintain the standards, the certification can be revoked.
ISO 9001:2015 evaluates the strength of an organization’s quality management system and associated processes. It assesses if all processes and systems are sufficiently robust, sustainable, and adhered to by employees at all levels of the organization. With the ISO 9001:2015 certification, Cryoport can provide a third party’s validation of our exceptional level of quality and organizational discipline.
Cryoport’s experts – scientists, engineers, and logistics managers – have spent years creating quality standards for our products and services. Cryoport created the Chain of Compliance® standard, which provides full traceability of the equipment and processes used in managing the environmental control of the therapies during their journey. We built our entire quality management system based on the ISO 9001:2015 standards, as well as the US-based Good Manufacturing Practices and the international Good Distribution Practices. [Learn more in this 2-minute video]
So it’s no surprise that Cryoport’s internal experts also consulted on the creation of the recently released ISO 21973:2020, which establishes guidelines for cell and gene therapy transportation. We, as an organization, expect the same type of inspectional success when there is an accredited body capable to perform the audit for ISO 21973:2020.
Cryoport is the trusted provider of logistics and supply chain support for nearly 500 cell and gene clinical trials worldwide, as well as four commercial therapies being distributed to patients today. We take that trust and our responsibilities seriously. The ISO 9001:2015 certification is proof of our commitment to excellence, our dedication to our clients, and our unparalleled services worldwide.
*The ISO 9001:2015 certification is designated for the Global Logistics Center in Irvine, which is the largest Logistics Center of Cryoport Systems. The audit process for ISO 9001:2015 certification of Cryoport Systems’ smaller logistics centers is underway.
