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 personalized therapies or any advanced therapy product.
Since TrakCel’s inception in 2012 I’ve seen a trend developing for cell and gene therapy companies supplying autologous or personalized 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 had 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 personalized 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 therapies since Dinah Washington’s 1959 hit, the importance of timely and effective treatment is as crucial today as it was then.
About Dr Matthew Lakelin
Dr Matthew Lakelin is a co-founder of TrakCel. Using his knowledge in handling and distribution of CGTs he has assisted with the development of the technology platform, writing user-stories for GMP critical functions. Matthew provides a technical bridge between the software development side of the technology platform and the GxP application of the system to ensure that the platform constantly evolves to meet customer needs as therapies change and develop.
Matthew’s focus is on the proliferation and democratization of advanced and personalized therapies to make them more accessible to those that need them.
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Article by Dr Matthew Lakelin - 11 Jul 2019
Dr Matthew Lakelin is a co-founder of TrakCel. Using his knowledge in handling and distribution of CGTs he has assisted with the development of the technology platform and is passionate about democratising advanced therapies. Matthew provides a technical bridge between software development and the GxP application of the system.
Matthew holds a PhD in Pharmacology and has over 20 years’ experience working in the pharmaceutical and biotechnology industry. Matthew is a TrakCel ATMP industry expert and in his role as VP Scientific Affairs is a key spokesperson and responsible for ensuring that TrakCel solutions continue to evolve to meet industry needs.