The rapidly growing field of cell and gene therapy is both exciting and confusing to many, including those who work in the medical community and on the periphery. Advancements of therapies happen at a feverish pace. The number of clinical trials increases exponentially in a short time. And bringing therapies to commercialisation remains a hurdle. Vince Paolizzi at Peli BioThermal highlights the Intricacies and Future Considerations for the Cell and Gene Therapy Cold Chain.
Extract:
Intricacies and Future Considerations for the Cell and Gene Therapy Cold Chain
As biotech companies navigate bringing cell and gene therapies from clinical trials to commercialisation, companies within the supply chain also work to understand and support this evolving field of medicine. In the case of cold chain, this means navigating variable temperature requirements and offering solutions that accommodate people unfamiliar with temperature-controlled packaging, as well as innovating ways to track and monitor irreplaceable raw material and completed therapies as they travel from and to the patient. As therapies reach commercialisation and advance beyond one-to-one treatments, adaptability and standardisation become increasingly important.
The Market
Cell and gene therapy are overlapping fields of biomedical research and treatment. Both serve to treat, prevent and cure genetic and acquired diseases. But they work differently. According to the American Association of Blood Banks, cell therapy replaces or repairs damaged tissues or cells with transplanted human cells. The cells either originate from the patient (autologous) or a donor (allogeneic). The applications are expansive, as there are hundreds of cells that make up the human body. Most cell-based therapies are currently experimental, with few exceptions. For example, hematopoietic blood stem cell transplantation was first explored in humans in the 1950s and is currently a well-established treatment for blood diseases.
Gene therapies, by contrast, replace genes to help the body fight or treat disease, turn off genes that cause problems or replace genes that cause problems with ones that work correctly. Once a new gene is created, a vector is used to deliver new genes directly into cells – either inside or outside the body. Gene therapy was first introduced in the late 1970s, and the first gene therapy trial in humans began in 1990.
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