Cell and Gene Supply Chain Services
Only Marken can seamlessly guide your cell and gene therapies through each stage of the pharmaceutical journey.
To ensure cell and gene therapies are brought to market successfully, pharma and biotech companies must address logistical complexities within the clinical supply chain, which requires specialized solutions, industry expertise and a rigorous control process coupled with advanced technology.
Marken’s unique cell and gene supply chain offering includes:
Cell and gene therapy expertise
Specialized teams of pharma industry and logistics experts providing direction on shifting regulatory and trade compliance guidelines.
24/7/365 Control Center
Our new Cell and Gene Control Center provides end-to-end monitoring and reporting on all cell and gene therapy shipments for enhanced visibility, enabling critical path decision making.
Flexible supply chains
Rapid manufacturing scheduling, lane design and verification, equipment validation, import/export expertise, and risk management helps facilitate agile decision making.
Real-time trackers, GPS systems and cryogenic capabilities reduce complexities related to chain of custody, identity and condition.
Cell and Gene Therapy Development
Sponsor or IP Holder
Sponsor or IP (Investigational Product) license holder with copyrights and confidential formulation or proprietary manufacturing process knowledge contracts out supply chain functions.
A vendor, such as Marken, assembles sample collection kits containing all the materials a technician needs to collect apheresis/leukapheresis or tissue samples, etc., in accordance with the study protocol.
Patient Visits Investigator or Physician
A physician or specialist enrolls the patient in a clinical trial or prescribes a commercially approved cell and gene therapy. The doctor then sends the patient to a clinic to provide their samples.
Apheresis Center or Clinic
At the clinic, the patient provides their cellular material, either blood or tissue. It is then shipped to a diagnostic lab or directly to a manufacturing facility, often at 2˚C to 8˚C or controlled room temperature. Cells lose viability quickly, so the next leg of the journey is usually the most time sensitive — 24 hours or less.
In some cases, when a manufacturer lacks the appropriate lab analysis capabilities in-house, the material goes to a separate diagnostic lab to be analyzed for cell count and other properties or for further processing before being sent to the manufacturing facility.
CMO or Manufacturer
With the addition of special proteins or viral vectors, the patient’s cells are modified to make the personalized medicine. This unique, proprietary manufacturing process could take four to 45 days.
Viral Vectors Manufacturer
When viral vectors such as retroviruses, lentivirus or adenovirus are used to house cell and gene therapies, these are mass produced by cell culture ahead of time. This manufacturing process can require a 12- to 18-month lead time.
Cryo Storage or Depot
Autologus drugs intended for the one person who supplied the original sample are quickly shipped back to that person under strict climate-controlled conditions, typically cryogenically at -150˚C or colder, sometimes in dry ice. Allogenic drugs made to treat a select group of patients with the same disease must be carefully stored at a depot until appropriate patients can be recruited into the trial or are prescribed the drug.
Administration of cell and gene therapies nearly always occurs in a hospital setting. Once patients leave the hospital, home healthcare technicians may be employed to assess the patient on follow-up, draw labs and deliver acute-care medicines like rescue meds or steroids.
The personalized cell and gene therapy is administered to the patient.
Marken White Paper
Solving Logistic Complexities in the Era of Personalized Medicine
Our latest white paper explores how next generation therapies are disrupting conventional supply chain logistics and how Marken's specialized services and capabilities help safeguard the viability and timely delivery of these potentially life-saving treatments.