Cell and Gene Therapy Logistics
Cell and Gene Therapy Logistics
ISO 21973:2020
As cell and gene therapies continue to expand, researchers increasingly require reliable logistical support. The safe and efficient transportation of cell and gene therapy products is now critical to patient care and manufacturing efficiency.
Pharmaceutical companies are required to comply with strict national and international standards, regulations and laws when developing and manufacturing their products. However, transportation companies, which are a critical part in the distribution of cell and gene therapies, are not required to abide by those same rules, putting the product at potentially significant risk.
That is why the ISO 21973: 2020 standard, entitled “General Requirements for Transportation of Cells for Therapeutic Use”, is an important step forward in ensuring that these life-saving and life-changing therapies are always transported consistently in compliance with the requirements for validation, verification, calibration, cleaning, decontamination, traceability, chain of custody, monitoring and quality management.
Cell and gene therapy also require high levels of logistical support to deliver each therapy to individual patients. Traditional cold supply chains had to evolve to meet the technical needs of laboratories and manufacturers alike.
In this way it can include new innovations in packaging / packaging, new storage options and validation of the cold supply chain, it is an important consideration when developing a reliable logistics support.
This ensures that the integrity of the therapy is maintained as it travels through the supply chain from the manufacturer to the physician and ultimately to their patients, making it easy to use upon arrival in the clinical setting.
Logistic solutions for cell and gene therapy:
- Expert Temperature-Controlled Logistics.
- Provision of Qualified Packaging.
- Chain of Custody.
- Air Charter Services.
- GPS Tracking & Leading Technology.
- Dangerous Goods Transportation.
- Regulatory Expertise and GDP Protocols.
