In 1959 Dinah Washington sang ‘What a difference a day makes, twenty four little hours’, you’ll have to indulge the reference to a jazz classic but time can be of the essence for the delivery of advanced therapy products.
Since TrakCel’s inception in 2012 I’ve seen a trend developing for cell and gene therapy companies supplying autologous therapies. The first few autologous treatments to be mapped and defined by TrakCel’s Process Analysts were all time-dependent, unstoppable processes, this dependency was not in recognition of the patient’s fragile condition but a reflection of the stability data (or lack of) for starting material and drug product. In a rush to demonstrate the efficacy of these novel treatments, little consideration was made to the practicalities of commercializing these treatments. In 2019, all therapies managed by TrakCel’s software have at least one cryopreservation step. This is providing flexibility of supply, making manufacturing assets easier to manage, allowing physicians to select convenient days for starting material collection and product administration, providing more time for QC analysis and QA release.
In 2019, all therapies managed by TrakCel’s software have at least one cryopreservation step.
Cryopreservation allows a pause in the supply cycle of autologous cell therapies, makings logistics easier and less likely to cause out of specification shipments (as a rule, the colder a shipment, the easier it is to maintain the shipping specification). Importantly, the reduction in time sensitivity of these advanced therapies (and in some cases starting material) provides time for patients to recover from temperature spikes and other complications which may delay them from receiving their therapy.
TrakCel’s cell and gene therapy software was initially designed to manage ‘fresh in, fresh out’ products, perhaps the toughest supply paradigm, orchestrating all parts of the supply cycle to manage therapies with limited stability data and challenging specifications. Sadly there are several cases of patients not surviving long enough to receive their therapy after donating starting material; take CAR-T treatments, these are currently administered when conventional standard of care has failed, so recipients of these therapies can be gravely ill. So despite an industry-wide move away from fresh in, fresh out’ reducing vein to vein time for treatments is a strategy being pursued across the cell therapy industry.
TrakCel’s cell and gene therapy software was initially designed to manage ‘fresh in, fresh out’ products, perhaps the toughest supply paradigm, orchestrating all parts of the supply cycle to manage therapies with limited stability data and challenging specifications
Today, TrakCel is being used worldwide to optimize the supply cycle of autologous, allogeneic and personalized vaccines; the experience gained in the company has been invaluable to its users, helping to reduce ‘vein to vein’ time, and simplifying the management processes of these products.
While much has changed in the advances of personalized medicine since Dinah Washington’s 1959 hit, the importance of timely and effective treatment is as crucial today as it was then.
The advanced therapy industry is constrained by its focus on manufacturing. The drive to reduce COGS, close and automate processes, create assay platforms, etc. are all critical.
However as advanced therapies increasingly reach market authorisation they need to utilise a logistics platform that connects patients to therapies.