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Delivering Custom Client Solutions

Cold chain solutions provider Sentry BioPharma Services is able to adapt to meet the diverse needs of its clients.

Custom cold storage units.

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.

CEO Spotlight: Tim J. Mitchell, JD

Sentry BioPharma Services’ chief executive talks about the company’s business highlights and industry trends.

Sentry BioPharma Services' main building

Tim Wright, Editor, Contract Pharma 10.14.20
Sentry BioPharma Services is a wholesaler and third party logistics provider of prescription and investigational drug products, medical devices, and active pharmaceutical ingredients (APIs) for the pharmaceutical and medical device industry.

Sentry’s founders created the contract service organization (CSO) to meet the rapidly growing demand for dedicated and highly-specialized contract GXP storage, labeling, packaging and supply chain management services.

Tim Mitchell is principal founder of the company and has been at its helm for the past fourteen years. As president and chief executive officer he has guided Sentry from inception through start up and onto profitability and mature growth. Contract Pharma recently had the chance to discuss Sentry’s beginnings and most recent business highlights as well as wider industry trends with Mr. Mitchell.

Contract Pharma (CP): Since founding Sentry, how has the company evolved from its roots?

Tim Mitchell (TM): When we began business in May 2007, we approached the market with three validated temperature ranges: +2°C to +8°C (REF); -15°C to -25°C (FRO20) and +15°C to +30°C (AMB) for management and distribution of temperature sensitive biologics, pharmaceutical materials, finished drug product and medical devices. Today we manage products within 9 separate validated temperatures from +20°C to +25°C (CRT) to <-135°C LN2.  The product profiles include finished drug product, APIs, excipients, as well as master cell banks. Further we label, kit and perform secondary packaging on drug products for distribution into 34 countries.

CP: What are some of Sentry’s most recent business highlights?

TM: This last 12 months have been crucial to Sentry. Our year-over-year growth rate for the last five years has averaged 34% annually. However, during 2020 we are experiencing a 56% growth in revenues over 2019.

Highlights include the completed validation of the new Controlled Room Temperature, +20°C to +25°C (CRT) addition with 1,500 pallet spaces, which will grow to 2,000 spaces by 2021, including active relative humidity control. We also added a former DEA caged, continuously monitored, enhanced security Ultra-Low Temperature freezer storage offering as well as custom steel mezzanine and infrastructure for up to 320 x Ultra-Low Temperature (ULT) upright freezers (-50°C, -70°C, -75°C and -80°C), which will be completed in November 2020.

We are also completing infrastructure build within a new second site for 50 x -80°C ULT freezers in Copenhagen, Denmark by the end of the fourth quarter 2020 and in Indianapolis, construction has commenced on a second 250 x pallet -20C walk in freezer, doubling site capacity and redundancy. Validation is to be completed by the end of first quarter of 2021.

CP: In which area(s) of Sentry’s business is it observing the greatest growth?

TM: The Ultra-Low Temperature (ULT) upright freezers with a validated set point of -50°C, -70°C and -80°C represent the greatest growth area. This has been driven by additional large molecule drug approvals and development.

CP: What are some of the crucial issues impacting pharma manufacturing and supply and logistics providers like Sentry in particular? 

TM: Crucial issues include the ready supply of -80°C ULT freezers.  Sentry’s normal experience is to receive new units within 3 business days. Today, because of short supply the time for delivery has extended to more than 10 business days.

In addition, the lack of international airline flights brought about by COVID-19 significantly impacted global drug distribution in the second quarter of 2020. Additional resources brought to bear by international freight carriers has somewhat alleviated this supply disruption.

CP: Are you seeing more business growth from new ventures or established organizations?

TM: A majority of Sentry’s growth is coming from its existing client base which stands at 130 pharmaceutical companies. Although some of these clients are small to medium virtual companies, many are large multi-nationals which seek out Sentry’s expertise in managing extremely cold supply chains. We continue to offer a white glove, customized, customer service-oriented experience to all clients, providing support in the areas of most crucial importance, on a per client basis.

CP: What are some trends in today’s pharma logistics market to keep an eye on?

TM: Pharmaceutical supply chain infrastructure is experiencing its own stress test, within this newest market trend of COVID-19 vaccine development. Upon commercialization of one or more promising vaccine candidates, the true extent of the effects on market supply and demand for pharma logistics will be clearer. Some things to consider include, end user (hospital, clinics, etc.) infrastructure for reasonable deployment of a finished vaccine, whether at standard or more exotic temperatures, which may not be readily available in the clinic.

All other commercial and clinical supply chains are vying for the same resources that were available, prior to COVID-19. This has caused a vacuum in certain markets, which Sentry is working to mitigate. Sentry expects to meet and exceed all client needs, though continues to rely upon our trusted qualified vendors for additional support in fulfilling global logistics on time and in temperature. We expect the next 18 months to yield a better picture on the logistics market, going forward.

CP: How is technology evolving to help logistics providers like Sentry serve clients?

TM: Sentry continues to utilize cutting edge technologies to mitigate risks associated with movement of high value temperature sensitive materials, globally. Some of these technologies include: advanced manufacturer qualified shipping systems to maintain temperatures for days at a time and active cellular/GPS based temperature logging systems with multi-variable alarming (light, pressure, shock, humidity, location and temperature) to track shipments in real time.

Technologies such as these, have allowed Sentry to open shipping lanes into the far corners of the globe, with the highest assurance of successful shipment fulfillment, in time and in temperature. We continue to invest in advanced supply chain infrastructure, to ensure Sentry’s clients are receiving best-in-class service and quality.

CP: What are some of Sentry’s plans for the near future? How about long-term growth plans?

TM: Sentry’s plan is to closely monitor our clients’ developing needs and seek avenues to fulfill these needs. In 2021 and 2022 we will be adding stability chambers and services to support client research and development; a secondary facility in the U.S. for the repository of ultra-high value material, as risk mitigation; and we’ll continue to build out services in Copenhagen to meet our clients’ EU and ROW service requirements.

On our longer-term plans, we intend to evaluate additions of further global depots, in support of ROW operations; evaluate the addition of laboratory services for pharmaceutical development; increase Sentry’s consulting capabilities to further assist our clients with regulatory support; and further expand the Indianapolis site to meet market demand.

CP: Please add anything else you would like to share with our audience about Sentry and/or the markets it serves.

TM: Sentry is a smaller company that continues to grow, with a nimble and knowledgeable team. We continue to add resources to meet the ever-expanding biologic pharmaceutical supply chain market. We do so with the utmost care, while ensuring all client needs are met with the appropriate response. This allows Sentry to service organizations including the smallest of pharmaceutical development companies, as well as the largest organizations in the world. 

Planning Around Disasters and Anticipating Challenges

How Sentry maintained business continuity during the COVID-19 pandemic and beyond.

Planning Around Disasters and Anticipating Challenges

Sentry Biopharma Services has a long history of experience in providing customized cold chain storage and distribution solutions across many temperature ranges as well as labeling, kitting, and packaging of clinical trial materials (CTM).
 
Its clients require effective custom solutions for cold storage and distribution to increasingly exotic locales in order to conduct trials in specialized populations.
 
Recently, the COVID-19 pandemic changed the business environment for many organizations around the globe, and highlighted the importance of being able to react, adapt, and set up crisis management mechanisms in order to weather situations of uncertainty.
 
How COVID-19 Impacted Business
 
Storage facility durability and safety in the face of natural disasters as well as business continuity during the COVID-19 pandemic are of great concern to Sentry’s clients.
 
“Initially, the COVID-19 pandemic caused a drastic decrease in availability of transport due to airline slowdowns, etc., and a resulting steep increase in transport costs,” said Alex T. Mitchell, Director of Operations for Sentry. “Fortunately, this has stabilized somewhat, and overall activity is increasing rapidly due, in part, to COVID-19 vaccine activities. Activities seem to be rebounding vigorously to the point that previous levels may soon be exceeded.”
 
Still, according to Mitchell it is not clear at this time what ongoing effects COVID-19 vaccine activities may have on the availability of cold chain storage space globally as well as cost and availability of transport. “Sentry is increasing its cold chain storage space and diversifying its transport options to be prepared for any such effects,” he said.
 
Challenges Beyond COVID-19
 
Primary challenges other than COVID-19 include prompt provision of customized cold chain solutions over an ever-increasing geographical range in a manner that ensures continuity and regulatory compliance. Sentry meets these challenges for its clients by provision of consulting assistance and extensive pre-planning for movements with backup provisions in case of failure of primary transport lanes. 
 
According to Tim J. Mitchell, President / CEO, pharma development activities continue to be well-funded with dramatically increased development of biological products requiring cold storage.  These include those directed toward orphan indications, as well as increased manufacturing of such products in U.S. and EU-based facilities.
 
“In the near future, increased development of biologicals including personalized gene and cell therapies, as well as increased manufacturing of such products in the U.S. and EU will drive the need for additional cold storage temperature space with various new temperature options, particularly in the colder ranges,”  predicted Mitchell. 

To meet these challenges, Sentry has expanded its Controlled Room Temperature and customized Ultra Low Temperature freezer storage options with enhanced security. Additionally, Sentry has implemented a renovated -40°C walk-in freezer with a new monitoring and control system; added vapor phase liquid nitrogen units for master cell banks and has strengthened its in-house regulatory consulting expertise. Sentry is in the process of adding a new Warehouse Management System which will enable advanced serialized labeling and tracking and has a second 250 U.S. pallet -20°C chamber under construction. Sentry is currently completing and expects to open a second facility in the EU in Q4 of 2020.
 
As Sentry moves on from the COVID-19 crisis, it is prepared for whatever obstacles may be thrown at it next.