Fisher BioServices Experts to Share Latest Cell Therapy Commercial Development and Cold Chain Challenges at the 2014 Cell & Gene Therapy Forum
As newly developed biopharmaceuticals move through clinical trials toward commercialization, the number of variables surrounding the handling and distribution of these high value cell- and tissue-based materials have increased exponentially. The packaging, storage, inventory management, monitoring systems, and distribution must all be carefully considered in meeting FDA and patient safety requirements.
Fisher BioServices is honored to have the opportunity to speak at the 2014 Phacilitate Cell and Gene Therapy Forum to share our experiences and insights into the packaging and distribution of biologically-base therapies. Our Cell Therapy Logistics expert, Dan H. O’Donnell, and our Director of Commercial Operations, Bruce C. Simpson, will each be presenting their experience and insights into the commercialization of these therapeutics.
If you are interested in scheduling an appointment with one of our representatives at this event please click here.
Planning for Commercial Success
Are your processes in place? Cryogenically frozen cells, if fully maintained at the correct temperature, retain their viability virtually indefinitely, but create challenges in storage and distribution. Keep in mind that at each stage of development, from phase I clinical trials through global commercial distribution, the proper infrastructure and processes must be in place. By failing to address storage, handling, packaging, and distribution of your product until clinical trials begin, you can limit your product’s scalability and commercial viability, incur unnecessary costs and complications downstream, and fail to meet FDA criteria for documentation of cold chain and chain of custody requirements.
Will your therapy require a unique means of patient administration? Ensuring consistency among all investigative sites is critical in meeting FDA criteria. If devising a unique process for patient administration is unavoidable, then in addition to training site personnel, consider providing each clinical site with identical equipment. If the consumables required are critical to the processing and administration, consider including an administration kit with each dose.
Where do temperature excursions happen? To be commercially successful, cell therapies must retain their viability and potency, and this requires protection from exposure to adverse temperatures. Any given individual dosage of a cell-based therapy is potentially exposed to up to eight adverse temperature events between manufacture and patient administration. These eight events occur when:
- The dose is transferred from the controlled rate freezing unit to the manufacturer’s temporary storage unit,
- The dose leaves the manufacturing facility (removed from temporary storage and placed in a container that is then loaded on a truck), and so forth.
Will that dry shipper do the job? An invaluable tool in the quest to transport cell-based therapies in a safe and effective manner is the dry shipper and its “sidekick,” the data logger. While the dry shipper is key to successfully shipping cryogenically frozen materials both internationally and domestically, misconceptions about the workings of these devices can jeopardize your success. Please see our Dry Shipping InfoPoster for the 10 most common misconceptions encountered in shipping high value biologics.
How do you avoid temperature excursions?
Companies must ship materials the right way to ensure compliance with FDA requirements, patient safety, and commercial success. The more you know, the better prepared you will be to face shipping challenges in the present and future.
Small volumes thaw quicker and require tighter control. However, a larger administration volume combined with effective packaging can make achieving the minimum threshold in temperature compliance and preservation of therapeutic potency easier (and less costly). Design your product handling processes to reduce exposure to the lowest level possible. Each out-of-temperature event puts the material at risk, regardless of volume.
The importance of temperature monitoring and testing of the static hold time of a dry shipper cannot be understated. Data loggers create a record of the internal temperature of the dry shipper while in transit. They can be set to the acceptable temperature window of the cargo and will alert the recipient if a temperature excursion occurred during the shipping process. However, attaching one to a dry shipper will invariably reduce static hold times.
How do you meet all of your chain of custody requirements?
Working with experts in cryogenic distribution, cold chain/chain of custody, and 21 CFR part 11 compliance will save you multiple headaches and misdirected resources in your journey to a commercially successful product. Fisher BioServices is on the forefront of cryogenic distribution systems. We are partnering with clinical sites, to equip them for the new era of regenerative and personalized medicine, as well as with companies who are developing cell-based therapies. We are the experts in getting your product from the manufacturing facility to the patient bedside in the most cost-effective manner while fully preserving therapeutic potency and viability. Please click here if you are interested in a tour of our biorepository and your storage options.
We are looking forward to meeting you at the upcoming Phacilitate Cell and Gene Therapy Forum on September 27th to 29th at Grand Hyatt Washington. Our Director of Commercial Operations, Bruce C. Simpson, will speak on January 27, 2014 at 10:20 AM on Ultra Cold GMP Storage and Global Distribution Strategies for Cellular Therapeutics Commercialization. In addition, our Cell Therapy Logistics expert, Dan H. O’Donnell will speak on the Ultra Cold Chain and Logistical Challenges of Clinical and Commercial Development of Cell Therapeutics on January 29, 2014 at 12:05 PM. If you cannot attend these sessions, please visit us at booth #21 and #22. If you are interested in more guidance on your cell therapy clinical and commercial development, please check out our eBook on Commercially Successful Cell Therapy (by Dan H. O’Donnell) and Defense in Depth for Biopharmaceuticals (by Bruce C. Simpson).