Summary:   We are all familiar with the potential for stem cells and regenerative medicine products to improve our lives.  However, many are unaware that the integrity of these products can be susceptible to temperature fluctuations, and that a product’s integrity can be irreparably damaged by substantial temperature changes.  For example, when exposed to high temperatures during transport, cord blood’s integrity can be negatively impacted.

Another challenge with stem cell and regenerative medicine products is trying to predict the optimum temperature range for a product during transport.  Here is a true story illustrating how a company learned this in a very unusual way!

Challenge:  After almost 10 years of research and tens of millions of dollars investment, a regenerative medicine company developed a new product for bioactive wound healing.  As most of their previous work had been with materials that were stored in refrigerators, they naturally assumed that the industry-standard refrigerated 2-8° C temperature range was ideal for their product.  This was reinforced by the knowledge that most of their competitors were also shipping their wound-healing products in shippers providing a refrigerated 2-8° C environment.  Since testing had shown that the company’s product had a shelf life of only 48 hours after manufacturing (similar to most of their competitors), the company recognized they had only 24 hours in which to ship their product to the physician or hospital in order for them to perform a successful patient procedure before their product expired.  With this in mind, the company developed a 2-8° C temperature-controlled shipper and instituted a program to ship their products “Priority Overnight” with an 8:00 am delivery deadline, maximizing the time available for the surgical procedure to be performed on a patient prior to the product’s expiration.

This Priority Overnight shipping mandate significantly increased shipping costs, but these higher costs were outweighed by the additional time provided for the procedure to be performed within the 48-hour shelf life.  However, the 48-hour window of time needed to both ship and perform the surgical procedure meant that the company was only able to ship the product on Mondays, Tuesdays and Wednesdays (shipping on Thursday would reduce the window of time for use by a full day, and a Friday shipment would expire before arrival on Monday morning).  Consequently, manufacturing was limited to allow shipping only three days per week, and could be even further reduced should a holiday occur during the work week.

A stroke of luck changed all that!  On leaving the lab one evening, one technician assumed that the other technician had returned some product to the refrigerator, and vice versa.  Upon discovery of the mix-up the next morning, they determined that the product not only had not suffered degradation, but looked better than ever!  After testing and retesting, it was determined that the product actually preferred a Controlled Room Temperature range, and not the 2-8° C range they had originally thought necessary, and that this change in temperature actually increased the shelf life of the product from two days to ten days!

This 10-day shelf life discovery was a tremendous advantage competitively; not only enabling the company to manufacture and ship Monday through Friday, but now the physician and patient would no longer be held captive to the product’s arrival and imminent expiration.

But first, the company needed a new shipping system that would protect their product by keeping it within the narrow temperature range of 20-25° C throughout the shipping period.

Solution:   After exhaustive research, the biotech company found that Saf-T-Pak’s unique Saf-T-Temp™ Controlled-Room-Temperature (CRT) Phase-Change Material (PCM) was the gel pack that could meet this critical 20-25° C temperature range under most, if not all, shipping conditions.  The STT-521 Controlled-Room-Temperature PCM is far superior to water-based solutions, as it maintains the CRT range with less PCM weight, resulting in  a smaller and lighter shipping package than alternative PCM solutions.  This lighter weight package translates into lower shipping costs, saving tens of thousands of dollars every year.  And, after the company’s testing showed that the STT-521 PCM maintained the 20-25° C temperature range in excess of four days, they were then able to safely ship the product overseas, and successfully market internationally.

Combining Saf-T-Pak’s STT-521 Phase Change Material (PCM) with their current insulated shipper resulted in complete temperature stability of the company’s product within the narrow, and technically-challenging 20-25° C temperature range.  This prolonged shipping life enabled the company to completely overhaul their operational procedures, thereby lowering their manufacturing costs. “Expired product” issues became almost nonexistent, also helping to lower total manufacturing costs.

Consequently, by determining the optimal temperature range for the storage and shipment of their bioactive wound care product, the company was able to re-launch their product with a new, ten-day shelf life!  The ten-day shelf-life afforded the company’s product a tremendous operational advantage over their competitors and dramatically increased their market share at the expense of their less flexible competitors.

The Bottom Line:   A better product, enhanced patient and physician satisfaction and lower manufacturing and shipping costs, all resulting in significant competitive advantages that ultimately eliminated much of the competition.  Due in part to the STT-521’s ability to provide unparalleled thermal stability throughout the shipping process,  this precious bio-active wound care product remained within the tight 20-25° C temperature range, thus extending the product’s shelf life to ten days!