Cell and Gene therapy trials require highly specialized services. Marken facilitates stable and secure transportation of these bio-hazardous samples, applying meticulous attention to detail with these sensitive shipments. Gene or cell based materials derived from patient samples must be shipped in cryogenic condition to reach manufacturing sites within 28 hours of the patient visit. Preparing the samples, transporting them across country borders, delivering the shipment and contents in ideal testing condition, manufacturing patient-specific vaccines, and finally shipping treatment to patient is a complex process.
Marken is one of the first logistics networks to offer liquid nitrogen storage capabilities that meet specific time and temperature-critical demands, such as minus 180 degrees Celsius shippers. Backed by an expansive global network of experts and GMP- compliant Clinical Supply Centers, Marken has managed logistics for global, multi-centered cell-based therapy trials involving nearly 1000 patients in over 20 countries.
Because regulations vary from country to country, Marken’s regulatory expertise, risk assessment and trade compliance team will help clients define, mitigate, and reduce potential risks when planning clinical trials. As gene and cell therapy trials continue to expand across the globe, Marken will continue to offer a holistic suite of services that supports logistics from beginning to end, from research to patient.
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