New Year, New Challenges, New Technology

Stability continues to be at the forefront of discussion in the Medical Product world. Newcomer cell and gene therapy products with patient-sized batches and extremely short shelf lives present a Stability challenge for creating effective protocols in determining storage condition borders and generating consistent data toward precise shelf life. Cannabis products, both recreational and therapeutic, are in need of test methods and shelf lives, but product uniformity is elusive and standard stability measures are held at bay. In balance, there are some very interesting stability-related prospects on the horizon.

Researchers at the University of Bonn have presented a method that allows the heavier hydrogen isotope-deuterium to be introduced specifically into many different molecules. The deuterated compounds obtained in this way have increased activation energies. “If you replace hydrogen with deuterium, the activation energy usually increases somewhat…As a result, reactions are slower.” Clinicians see products with lower doses and longer half-lives, but Stabilitarians see longer shelf lives in the offing. The process is still in formative stages and very expensive, but the technology is exciting and further work can bring it closer to practical application.

Tatiana Nanda and Brian Tomkowicz of Vector Engineering & Manufacturability, Center for Breakthrough Medicines refer often to Stability in their Pharma Manufacturing article “A right-first-time approach to development” as they explore commonly overlooked issues that may have a deep impact on cell and gene therapy commercialization timelines.

Follow these developments in further detail at:

• Deuterium (Extended stability)
• Right First Time Cell & Gene Therapy Development