Case Study

Scaling The Advanced Therapy Supply Chain

Fisher

Treating castration resistant prostate cancer means that failure within the advanced therapy supply chain has a catastrophic impact on patients. This case study describes the use of dispersed storage and cold chain logistics, around a central manufacturing facility to create a cost efficient and robust supply chain.

SOTIO

SOTIO is part of the PPF Group and leads its efforts to build a diverse biotechnology portfolio through its own research & development, collaborations, in-licensing, investments, mergers and acquisitions. The company is developing an autologous dendritic cell vaccine (Active Cellular Immunotherapy (ACI)), targeting cancer and autoimmune diseases. The Prague-based organization is successfully conducting clinical trials in prostate cancer (global PhIII “VIABLE” study and 5x PhII studies targeting different patient populations), epithelial ovarian cancer (3x PhII studies), and advanced metastasis of non-small cell lung cancer in conjunction with standard chemotherapy (PhI/II study).

VIABLE Trial and the challenges of scaling its supply chain into PhIII and beyond

The VIABLE trial is a randomized, double-blind, multi-centre parallel-group Phase III study. It is designed to assess the efficacy and safety of the ACI in combination with standard of care in comparison with placebo and standard of care in men with metastatic castration-resistant prostate cancer eligible for first line chemotherapy.

For the supply chain, this means management of time critical, temperature controlled shipments to/from more than 20 EU and non-EU countries and the treatment of over 1000 patients.

To maximize efficiency SOTIO pursued a single manufacturing site strategy that has the capacity to manufacture all of its global clinical trial needs. The inbound cellular supply chain is leukapheresis at 15-25oC, with a 30-hour shelf life. The outbound cellular supply chain uses cryogenic storage hubs and distribution.

In addition, there is a critical consumable supply chain that needs to ensure that donation and treatment kits, as well as the secondary packaging and labelling systems, operate in synergy with the cellular supply chain.

SOTIO had delivered early trials by using its in-house cryo-store and shipping under dry-ice to recipient centres. The plan was to scale this system into the PhIII trial. However, this proved to be impractical and too expensive for three primary reasons.

Supply Chain Barriers

  1. Inbound supply chain - Challenge of managing the delivery of pre-conditioned packaging to the donor leukapheresis site and coordinating this with patient/clinician availability across multiple countries. There are also limitations in transport including available flights to donor destinations, crossing borders, and different languages.
  2. Outbound supply chain - Complexity of managing multiple sites, packaging (construction and disposal), differing regulations, different languages, and return of empty cryo packaging back to storage.
  3. Storage and distribution – Product shelf life provided by dry-ice and SOTIO’s ability to store the volumes required, limited logistical scope of the study. With future commercialization in mind, it also was impossible to see how this system could be scaled to the volumes anticipated at market launch.

Fisher BioServices CryoHubSM

CryoHubs are dedicated advanced therapy storage and distribution facilities strategically located around the globe to support the cell and gene therapy industry. The facilities provide -20°C, -80°C and -190°C cGMP management capabilities, combined with quality controlled systems for donation kit production & distribution, secondary packaging & labelling, QP release, and monitored and managed cold chain logistics.

Fisher BioServices’ CryoHubs are located within the world’s key advanced therapy clusters (Europe - Stevenage/UK, North America – Maryland/USA, and Asia – Tokyo/Japan). This gives an immediate ability for therapy developers to utilize standard systems on a global scale and distribute advanced therapies quickly to patients. As part of the wider global operations the CryoHubs can be deployed into over 30 divisional cGMP facilities as market demand grows. This ensures that advanced therapy developers have a scalable solution for their therapies commercialization.

Solution

Through utilizing the CryoHub infrastructure and the supply chain management experience of Fisher BioServices, SOTIO has fully completed enrollment of the VIABLE study and treated already more than 1000 patients.