Case Study
Challenge
Before administering the sponsor’s allogeneic NK cell therapy product, a critical step involves lymphodepletion using Fludarabine (Flu) and cyclophosphamide (Cy) chemotherapy.
The preparation of these agents must be tailored to each patient’s weight, requiring sterile compounding of hazardous drugs on demand. However, some investigational sites lacked the on-site pharmacy capabilities needed for such precise and sterile preparation. This limitation restricted the sponsor’s ability to include these sites in the trial, potentially excluding valuable patient populations.
The sponsor sought a partner to provide compliant sterile compounding services to enable broader site participation and ensure patient safety.
The Myonex Solution
Saveway Compounding Pharmacy, a Myonex company, offered a seamless solution with its advanced sterile and hazardous drug compounding capabilities and compliance with USP 797 and USP 800 standards.
Based on each patient’s prescription, Saveway prepared Fludarabine (Flu) and Cyclophosphamide (Cy) infusion bags, precisely adjusted to weight-specific requirements.
The sponsor benefited from streamlined logistics, with compounded bags shipped to sites in insulated containers at 2–8C. Sites received ready-to-use sterile patient specific lymphodepletion bags and IV sets sourced by Myonex.
Investigational sites with limited pharmacy capabilities can store the prepared bags in refrigerators and site staff administer them to patients during study visits, simplifying the infusion process. This permitted sites without a compounding pharmacy to enroll patients in the study.
Results
Ready-to-Use Infusion Bags: Provided weight-titrated chemotherapy bags with IV sets contributed to standardized trial results.
Patient Safety Assurance: Strict compliance with USP standards for compounding sterile chemotherapy doses.
Diversity, Equity and Inclusion (DEI): Investigational sites without chemotherapy preparation capabilities to participate were equipped, expanding the trial’s reach and enabling access to a broader and more diverse patient population.
Clinical Staff Safety and Enhanced Site Support: Reduced safety risks associated with handling hazardous drugs on-site, while freeing up clinical staff to focus on patient care and infusion processes.
Conclusion
Through its sterile and hazardous drug compounding expertise, Saveway Compounding Pharmacy, a Myonex company, enabled the sponsor to extend its clinical trial to sites unable to handle lymphodepletion agent preparation.
This support ensured safe, ready-to-use chemotherapy admixtures for patients, eliminating risks and saving time for paramedical staff and patients.
By addressing these logistical and safety challenges, Myonex empowered the sponsor to make its innovative “off-the-shelf” allogeneic NK cell drug candidate more widely available in its clinical trials.