With the proliferation of biopharma products that tend to be temperature-sensitive has come the need for more custom cold chain solutions.
 
Fortunately, Sentry BioPharma Services exists to provide FDA compliant packaging solutions and supply chain management services to global pharmaceutical, biotechnology and medical device firms.
 
The company offers storage at nine different temperatures ranging from controlled room temperature down to less than -135˚C, and Sentry is able to provide other customized frozen temperatures between -40 to -90˚C as needed. Sentry also has expertise regarding shippers for frozen products, for example using Phase Change Materials (PCM) and can provide the latest in electronic tracking and environmental monitoring technology during shipment.
 
As an entity in a highly regulated industry, Sentry has expertise in regulatory requirements and best practices that it leverages for its own compliance as well as on an advisory basis for its clients.
 
“The challenges arise due to Sentry’s diverse client base, which may include startups that may not have the regulatory knowledge base or experience that other clients may have, and many of our clients who are foreign may have great expertise in regard to their local regulatory requirements, but not so much in regard to FDA’s requirements,” remarks John A. Warner, Executive Vice President of Sentry. “On the other hand, some of Sentry’s domestic clients may not have expertise in regulatory requirements required for distribution of pharmaceutical materials into other countries and Sentry can help in these instances as well.”
 
Experience with Diverse Clients
 
Sentry BioPharma Services’ experienced team offers a practical and pragmatic approach to collaboration with its pharmaceutical clients to solve complex issues surrounding temperature-sensitive drug management and distribution while safeguarding drug safety, identity, strength, purity and quality (SISPQ). 
 
“We work around the global clock to ensure close communication and responsiveness to our clients’ needs in many (many!) time zones.  Sentry is quite experienced in shipping from its facility in Indianapolis to sites around the world, including some ‘exotic’ locales, and we do this on a daily basis,” Alex Mitchell, Director of Operations explains.
 
The company prides itself in its ability to listen well and ask probing questions to uncover the actual problems of its clients so that they can arrive at feasible solutions.
 
“Sentry is most successful, and we feel our clients are most successful, when there is open and close communication,” says Mitchell. “To this end, we focus on prompt and responsive communications with our clients and we do not run a ‘taxi meter’ and charge for each and every communication with them.”
 
Overcoming Challenges
 
Developing and delivering new drugs and biological products in a highly-regulated industry offers unique challenges to executives, project managers and functional managers alike.
 
The common element that each collaboration presents is that generally each client’s needs are somewhat unique, according to President and CEO, Tim J. Mitchell.
 
“The materials stored by Sentry vary and may be held at quite different temperatures. They can range from raw materials being sent for further manufacturing or commercial finished products intended for distribution to market, or investigational products intended for clinical trials, or unlabeled materials that Sentry is labeling prior to distribution,” he says. “Sentry’s clients include 12 of the top 20 large pharma companies as well as medium to small companies and even new startups. These firms come from all across the U.S. as well as from more than 20 countries across the world.”
 
Stories of Success
 
When a customer needs help, Sentry’s custom solutions are more than capable of handling small and large challenges.
 
For example, according to Warner, one of Sentry’s clients recently needed an investigational product shipped to a clinical study site in Bangladesh, but an event of civil unrest had disrupted transportation in the country. Sentry used cutting-edge electronic tracking/environmental monitoring technology to successfully track the product’s movement at the required temperature through the country and safely deliver it to its destination.
 
Mitchell describes another successful case study, one that really highlights the vital, oftentimes life changing and saving role pharma service providers like Sentry provide.
 
“A few years ago on a Tuesday afternoon right before Thanksgiving we received a call from a research hospital in Baltimore with an urgent request. A cancer inpatient was due for her next clinical trial treatment the next day, Wednesday, and was told that she could then go home to her family for the holiday. However, there was a problem.
 
“The hospital discovered it had exhausted its supply of the required medication and subsequently called us directly. We went into action, assembled a team on the spot and with client approval were able to deliver the required medication by 10:30 AM the next day. The patient was dosed and allowed to go home to be with their family for Thanksgiving.
 
“Most times, we do our jobs at Sentry and do not receive much feedback, but not this time.  Subsequently we received thank you letters from the hospital, the physician and the patient’s family.”
 
Prepared for the Future
 
Storage of products at frozen temperatures, perhaps spurred on by the need to store vaccines, will continue to increase, and as personalized gene therapies evolve, there will be more demand for just-in-time cold chain distribution directly to patients and/or their caregivers.
 
“Sentry is ready for the obstacles of the future and continues to both increase capacity of existing temperature environments, and to customize storage at new temperatures,” Warner says.
 
“Development of both a second site in the U.S. as well as in the EU are underway,” he adds, so you can bet that Sentry is prepared for whatever the future may bring.

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