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Regulatory compliance for CGT clinical trial logistics

Regulatory compliance for CGT clinical trial logistics

When planning international clinical trials, knowing that an investigational product will arrive safely, on time, and in line with local regulations is fundamental. For cell and gene therapies (CGTs), also referred to as advanced therapy medicinal products (ATMPs) in the European Union (EU), additional care is essential, due to the unique transport needs and the differences in regulations from country to country. 

There are some internationally accepted standards that provide general requirements for the transportation of CGTs. For instance, ISO 21973 emphasizes the need for monitoring and controlling transportation conditions, as well as managing traceability and maintaining chain of custody throughout transport. Even so, individual regions and countries also have regulations of their own.

Understanding local regulatory requirements and region-specific challenges is key to successfully transporting CGTs to various global locations. However, with CGTs being so novel, industry standards are evolving, and regulators are scrambling to keep up with their ability to oversee these developments. We discuss relevant regulations in the United States (U.S.) and the EU for CGT/ATMP clinical trials, along with strategies for staying abreast of shifting regulations. 


U.S. Regulations

In the U.S., the Food and Drug Administration guidance, Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug (IND) Applications, holds the most relevance for CGT logistical coordination. Specifically, it calls for a description of how the product will be shipped and received at the clinical site, in addition to providing information on the required shipping and storage conditions. Additionally, information on the chain of custody from the manufacturer to the site of administration should be provided. These transport guidelines center around ensuring the safety, stability, and quality of the therapeutic product. 

Also relevant to logistics and the shipping process are the guidelines, in the same document, on the container and closure system. Proper packaging and closure will help to prevent leakage or contamination during shipping, when a product may be exposed to more motion or different cooling methods than they may in a controlled environment. 

According to the guidance, important considerations for containers and closure systems include materials used, and protection from moisture, gasses and light. It advises providing a description of the suitability of the container closure system for the storage, transportation, and use of the product. To this end, another recommendation is to conduct stability studies that include protocols for container and storage conditions, among other variables, to ensure they are sufficient to protect the product’s viability. 

EU Regulations

Meanwhile, the European Commission (EC) drafted the Guidelines on good clinical practice specific to advanced therapy medicinal products to govern ATMP clinical trials taking place in the EU. Similar to the guidance in the U.S., this document requires detailed instructions on shipping, and how the product should be handled at the trial site. On top of this, in cases in which temperature control is relevant — which includes a large proportion of ATMPs/CGTs — temperature monitoring and logs are required to be certain that the ATMP is consistently maintained under the correct conditions.

Another important point in the EU regulations is traceability. Because ATMPs are often custom made for each patient, it is critical that patients receive the correct therapy. This means that at no point in transportation or storage can any specific therapies afford to be mistaken for any other. As a result, the EC’s guidance emphasizes the need to establish a system of bidirectional traceability — or, the ability to trace cells or tissues from donor to recipient, as well as from the recipient back to the donor. The trial sponsor is responsible for ensuring the manufacturer sets up this system from the outset, and for providing investigators with detailed instructions to safeguard traceability. Adding another complication, personal data protections in the EU mean that this tracing must utilize an anonymous coding system, so as not to compromise the identities of the donor or recipient.


Staying abreast of shifting regulations

As our use and understanding of CGT therapies expand, it’s only reasonable to expect that regulations will continue to evolve. To stay up to date on regulatory requirements, and to know when a major change is coming, continually monitoring regulatory news is an important practice. Still, even when maintaining this ongoing monitoring, it can be difficult to know every one of the regulations relevant to all potential trial locations. So, conducting thorough research prior to beginning clinical trials is important. Establishing relationships with local regulatory bodies, or having regional contacts who regularly interface with these regulatory bodies, can also provide insight on how to prepare for logistical requirements. 

Trial sponsors can also turn to the regulatory experts at biopharma services companies, such as Yourway. On top of handling all of the above recommendations, Yourway can help create a logistical strategy in line with local and regional regulations prior to initiating trials. Our experienced staff can also help to smooth common regulatory challenges for international transport, such as customs clearance and importer of record coordination.

To learn more about logistical considerations for CGT clinical trials, read Yourway’s whitepaper,  or get in touch at info@yourway.com.

 

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