Sentry Biopharma Services protects the integrity of temperature sensitive biopharmaceutical products during the clinical and commercial phases of development.

Sentry Biopharma Services specializes in the storage and global distribution of temperature sensitive biopharmaceutical products catering to companies that are seeking a vendor with a consultive approach who can provide high quality, high touch customer service as well as reliable, customizable processes and timelines that meet regulatory standards for the storage, distribution, packaging, and logistics of their pharmaceutical products and supplies.

Sentry is committed to ensuring the safety, identity, strength, purity, and quality (SISPQ) of our clients’ materials during clinical trials through development and commercialization.

To this end, Sentry’s state-of-the-art facilities are specifically designed for this purpose featuring redundancies for each temperature environment, facility power, and critical systems such as warehouse management (WMS), building management (BMS), IT infrastructure, security, and safety. 

Furthermore, Sentry’s Quality Assurance team verifies all operations are performed in a manner consistent with GMP standards and documented standard operating procedures while validating all environments, WMS, and BMS for optimal performance.

The need for temperature sensitive biopharmaceutical storage and distribution has exploded, and Sentry Biopharma Services is proud to provide supply chain expertise to ensure our clients’ medicines are effective when they reach the patient.  Sentry strives to be more than a partner to our clients. We want to be an integral part of their team, working together to define the best solution possible to meet the ever-changing challenges in the industry today and in the future.

Sentry BioPharma Services: Adding Supply Chain Value as a Foreign Trade Zone

Sentry BioPharma Services, Inc. (“Sentry”), specializes in providing cold chain storage and distribution services to the life science industry with a focus on large molecule pharmaceutical substances that are typically highly temperature sensitive.  Sentry broke ground on its location adjacent to Indianapolis International Airport in 2006.

The location is extremely important for Sentry, because it serves a strategic purpose, Alex Mitchell, Sentry’s Director of Operations explains.  The airport, which is just minutes away from the facility, serves 12 major airlines with more than 280 daily flights.  Furthermore, proximity to FedEx’s second largest hub enables Sentry to capitalize on late drop times, promoting effective west coast and global pharmaceutical distribution.  FedEx has announced and is underway to construct an additional runway at Indianapolis International Airport, via a ~$1.5 Billion infusion into the Indianapolis hub.  This will further extend the reach of Indianapolis, both domestically and globally.

It is also located less than four hours from O’Hare International Airport in Chicago, Illinois, which directly serves many international cargo destinations.  Memphis International, Louisville International, Cincinnati International, and Chicago International Airports are all within close proximity of Sentry and are also each within the list of the top 10 busiest cargo airports within the US.  Additionally, four major interstates convene in Indianapolis (I-65, I-69, I-70 and I-74), providing one day driving access to 80% of all U.S. businesses.

All of these factors help Sentry provide reliable, flexible services and timelines for its clients. However, one of the most important benefits of Sentry’s location in Indianapolis is its status as a Foreign Trade Zone (FTZ), which was part of the initial planning for Sentry even before ground  was broken, says Tim Mitchell, Sentry’s President/CEO.

What is a Foreign Trade Zone?

A Foreign Trade Zone is a secure area supervised by the Customs and Border Protection in which domestic and foreign merchandise are treated as being outside the U.S. trade boundaries.

According to Tim, “The benefits of our FTZ include Duty Exemption/Reduction as well as Merchandise Processing Fee (MPF) reductions. It is possible to completely avoid paying duties by utilizing the FTZ.  Except for exports to Canada and Mexico, there are no duties on re-exports, meaning that a company can import to an FTZ and then export to another country without ever having to clear customs or pay duties or excise tax. When using an FTZ, companies are only required to pay MPF when their goods are entering U.S. Customs territory. In addition, companies using an FTZ can file a single entry for all the goods they ship from the FTZ in a consecutive seven-day period.”

Benefits of an FTZ also include capabilities to bring pre-IND, NDA, ANDA, BLA and EUA materials into a facility geographically located in the United States, without having final regulatory clearance for import, according to Alex. “The FTZ can support initial clinical trials and commercial product launches, especially as materials can be manipulated/packaged within the zone, while awaiting clearance.  Materials can also be held indefinitely in the USA within Sentry’s FTZ, until such a time as further manipulation, export or import activities are required.  This process is driven by Sentry’s clients and supported by Sentry in a consultative approach, to ensure maintenance of compliance and supply chain integrity.  Additionally, the FTZ allows for materials to be brought directly into GMP inventory control from their US port of entry, without having to await customs clearance,” Alex said. “This can be especially beneficial for temperature sensitive and high value materials.”

All of these benefits are offered directly to Sentry’s clients. For example, Tim explains that temperature sensitive materials may be transported by bonded truck from the nearby Indianapolis airport to Sentry’s facility (a 15-minute trip) and be placed directly into the appropriate GMP storage environment without any risk of a Customs, DEA or FDA delay at port of entry.  The material can then remain in the FTZ and be cleared for further transport within the U.S., when the appropriate regulatory approvals have been received.

Sentry also offers custom batch record-controlled labeling, kitting, and packaging services and maintains an FDA labeler code.  Materials such as investigational drugs can come to Sentry’s FTZ, be labeled, kitted, packaged, and stored in a controlled cold chain environment according to GMP requirements before being shipped out to foreign clinical sites without ever having to clear U.S. Customs.  In essence, the material is then never in U.S. commerce, though can be stored and secondarily packaged in a controlled environment, for further export.

Sentry has supported several BLA- and EUA-based launches with great success by reducing product time to patient and the risks associated with manufacturing drug products outside of the U.S.  The FTZ and its close proximity to the Indianapolis International Airport are just two of many advantages that Sentry provides for our pharmaceutical clients to ensure their drug products reach the market safely, efficiently and with proper efficacy.

To learn more about Sentry’s FTZ program please visit our website www.sentrybps.com. For specific inquiries, feel free to send us an email via BD@sentrybps.com or call us toll free at 866-757-7400.

A Foreign Trade Zone (FTZ), U.S. Customs and Border Protection (CBP) writes[1], is a secure area supervised by CBP, but treated as being outside United States trade boundaries.  Companies utilizing an FTZ have the legal opportunity to pay lower duty rates or possibly avoid paying them altogether as merchandise does not incur duties until it exits the FTZ into the United States Customs territory.  This gives companies that utilize an FTZ the ability to save money and manage their cash flow.

Duty Exemption/Reduction

It is possible to completely avoid paying duties by utilizing an FTZ.  Except for exports to Canada and Mexico, there are no duties on re-exports meaning that a company can import to a FTZ and then export to another country without ever having to pay duties or excise tax.

If a company plans to eventually have their merchandise enter the United States market, they can also save money by utilizing an FTZ.  While in the FTZ the company’s merchandise is not subject to U.S. duties meaning the company will not have to pay duties until the merchandise is entering consumption to CBP territory.  Companies are normally able to choose to pay the duty rate applicable on the foreign material or the duty rate on the finished product, allowing companies to choose whichever option is to their advantage. 

Merchandise Processing Fee Reduction

The Merchandise Processing Fee (MPF) is another way companies can save by utilizing an FTZ.  When using an FTZ, companies only have to pay MPF when their goods are entering U.S. Customs territory.  Merchandise Processing Fees, NAFTZ writes[2], are currently charged at 0.3464% of the total estimated value of the shipment, having a minimum fee of $27.23 and a maximum fee of $528.33 for each entry.   Companies using a FTZ can file a single entry for all the goods they ship from the FTZ in a consecutive seven-day period.  Normally companies would have to file one entry for each shipment (other than merchandise subject to live entry).

Sentry BioPharma Services, Inc. (Sentry) FTZ

Sentry BioPharma Services, Inc. (Sentry) is a provider of contract GMP cold chain storage and distribution services for its clients’ pharmaceutical materials. Sentry’s entire facility offering several different cold chain storage options is an FTZ and, as such, the benefits mentioned above are available to its clients. For example, imported APIs that will ultimately be sent to a U.S. CMO may be held at controlled temperature GMP storage until needed to be formally cleared through Customs to be used in manufacturing. Similarly temperature sensitive materials may be transported by bonded truck from the nearby Indianapolis airport to Sentry’s facility (a 15 minute trip) and be placed directly into the appropriate GMP storage environment without any risk of a Customs, USDA or FDA delay for the material to be cleared for further transport within the U.S.  Sentry also offers custom batch record controlled labeling, kitting, and packaging services and materials such as investigational drugs can come to Sentry’s FTZ, be labeled, kitted, packaged, stored in a controlled cold chain environment according to GMP requirements, and shipped out at any time to foreign clinical sites without ever having to clear U.S. Customs. Sentry’s FTZ is also often utilized for stockpiling of imported finished dosage stock or API to be used for commercial launch in the U.S. pending FDA approval of the appropriate BLA, NDA, etc.

Visit Sentry’s website, or contact us by e-mail at https://sentrybps.com/contact-us, bd@sentrybps.com, or by telephone at 1-866-757-7400 or 001-317-856-5889 (International) to find out how Sentry’s cold chain FTZ storage can benefit your company.  

[1] “About Foreign-Trade and Contact Info,” U.S. Customs and Norder Protection, accessed September 20, 2021, https://www.cbp.gov/border-security/ports-entry/cargo-security/cargo-control/foreign-trade-zones/about

[2] “FTZ Basics & Benefits,” NAFTZ, accessed September 20, 2021, https://www.naftz.org/ftz-resources/ftz-basics-benefits/

Released by Sentry BioPharma Services

In, as it says, what now appears to be a prescient discussion described in an article written in April, 2020[1], Tim Gunn wrote about how vaccine cold chain supply practices were soon going to be put to the test to store and distribute COVID-19 vaccines. Now, with vaccine distribution having been ongoing for several months, in a recently published book a chapter is included in which a group of analysts at the US Army Engineer Research and Development Center called for proactive application of resilience analytics to vaccine supply chains in order to increase the probability that vaccine programs will have continued functionality in the face of somewhat predictable disruptions[2].

According to the authors, a review of publications from 2020 regarding the vaccine supply chain revealed a lack of evidence-based models and a narrow focus on only portions of the overall supply chain network. Thus, they advocate for a comprehensive, quantitative approach to modeling and analyzing vaccine supply chain resilience.

Such an analysis, they say, should be based upon a “network model encompassing……. the manufacturing ecosystem, to the cold chain and the last mile [delivery and administration], to reverse logistics and waste management…”, and taking into account network interdependencies and trade-offs.

As background to their recommendations for resilience analysis, the authors summarize the overall vaccine supply network and specific disruptions that may occur. And, as has now become all too familiar during the pandemic, the cold chain is one of the more important components described. As the authors indicate, “Most pharmaceutical companies rely on service providers for distribution of temperature dependent products.”

Requirements for the cold chain listed include appropriate equipment capable of responding to different vaccine storage temperature requirements, proper protocols and procedures among the adjoining networks, trained personnel, and ready transportation. Possible disruptions mentioned include loss of power and, as is recently becoming more prominent, cyber-attack.

At Sentry BioPharma Services we take great effort to provide such resilience with redundant equipment, multiple power supplies, robust physical and cyber security, highly trained expert staff, and qualified, reliable transportation partners. We invite you to learn more on our website, or contact us by e-mail at https://sentrybps.com/contact-us, bd@sentrybps.com, or by telephone at 1-866-757-7400 or 001-317-856-5889 (International).

[1] Gunn, T. How the cold chain could prove vital in the fight to tackle the coronavirus pandemic. NS Healthcare, https://www.ns-healthcare.com/analysis/cold-chain-coronavirus-vaccine/ (Apr 23, 2020).

[2] Golan, M.S., et al. The Vaccine Supply Chain: A Call for Resilience Analytics to Support COVID-19 Vaccine Production and Distribution in Trump, B., Keenan, J., Linkov, I. “COVID‐19: Systemic Risk and Resilience” Springer (2021) in press. Preprint at https://arxiv.org/ftp/arxiv/papers/2011/2011.14231.pdf (2021).

How Sentry BioPharma Services supports clinical studies with just-in-time custom labeling/kitting/packaging and more.

Released by Sentry BioPharma Services Contract Pharma Staff 06.17.21
As crucial to innovation as they are, clinical studies come with a unique set of logistical challenges that can leave sponsors scratching their heads in confusion if they are not properly equipped to handle the situation.

For instance, larger clinical studies often require a depot supply of the investigational drug, and possibly comparators, stored at the proper temperature(s) awaiting labeling, kitting, and packaging according to the unique requirements of each study, and able to be shipped to clinical sites, which may have a limited storage capacity, on a just-in-time basis. If any of these conditions are not met, the quality of an expensive and time-consuming study may be significantly affected. 

Furthermore, if, as anticipated, clinical studies soon involve personalized gene therapies, there will be an even greater need for just-in-time custom labeling, kitting, and packaging targeted to specific study patients.

“Cold storage facilities are expensive to build and maintain and require skilled personnel both for facilities operation and maintenance, and for regulatory compliance,” explains Tim J. Mitchell, President/CEO of Sentry BioPharma Services. For example, Sentry’s facility is equipped with state-of-the-art redundant refrigeration equipment, security, building management/temperature monitoring, inventory management, and backup power systems for storage of temperature sensitive investigational products.

“Add to this the need to label, kit and package temperature sensitive investigational products according to strict Time-Out-of-Temperature limits, needing to ship precise quantities just-in-time to various clinical sites both domestic and foreign to meet tight study schedules, and all the while doing so with timely and transparent communications to clients and clinical sites. It becomes a demanding and complex process with significant hurdles,” Mitchell says.

These factors are why many companies engage Sentry for assistance with clinical study services.

Sentry’s Offerings

Sentry offers a full range of storage environments including refrigerated, frozen (-20°C, -40°C, -80°C and custom temperatures between -20 to -90°C), cryogenic temperatures at <-135°C, as well as controlled room temperature (+20 to +25°C) with controlled humidity. 

Sentry also offers labeling, kitting, and packaging services, with particular expertise for labeling of frozen materials in controlled Time-Out-of-Temperature, provides distribution/transportation services through qualified vendors for fast, reliable, transportation to clinical sites around the world, has expertise regarding shippers for frozen products, and can provide the latest in electronic tracking and environmental monitoring technology during shipment.

“Sentry’s custom labeling, kitting, and packaging services for clinical studies allow its clients to meet critical regulatory requirements to maintain product quality, traceability, and documentation for temperature sensitive investigational products,” comments Alex Mitchell, Sentry’s Director of Operations. “This is accomplished while eliminating any possible negative effect on study quality and doing so in a manner complying with strict study timelines.”

According to Mitchell, Sentry provides custom labeling, kitting, and packaging services meeting its clients study-specific requirements which may range from needs for blinded labeling according to randomization sequences to booklet labels which may include specific study instructions.

Solving Problems for Clients

“Sentry’s clients for our clinical studies services must have reliability, quality, attentiveness, responsiveness, prompt individual attention, meticulous attention to detail, and maintenance of product quality in order to meet the logistical requirements of clinical studies. Typically, this all takes place under extreme time pressure,” remarks John Warner, Sentry’s Executive Vice President. “Sentry takes great pride in using its experience and capabilities to be a problem solver, not a problem creator, for its clients.”

The company uses innovative label substrates and adhesives, allowing labeling of extremely cold product and meeting strict Time-Out-of-Temperature limits. Sentry also utilizes innovative technology such as the latest phase-transition shipping containers, and sophisticated electronic tracking and monitoring devices during shipping.

“For the most challenging of shipment lanes, Sentry uses advanced technology which pushes real time telemetry of critical data to Sentry’s IT system,” Warner says. “If a triggering event occurs, Sentry key personnel are alerted immediately via email and cell phone text wherever they may be located around the globe.”

Sentry’s clients for clinical studies services may engage Sentry at any stage of development for services as needed. However, Warner emphasizes that Sentry is often able to provide even greater assistance regarding study logistics if it is engaged at very early stages of clinical study planning.

For further information contact Alex Mitchell at BD@sentrybps.com or 1-317-856-5889.

How full range of storage environments and services of Sentry BioPharma Services, Inc. (Sentry) save time and money for pharma companies.

Released by  Sentry BioPharma Services •Contract Pharma Staff• 03.31.21
A significant recent trend in the biopharma industry has been an increasing number of large molecule biological products requiring refrigerated or frozen storage—a trend that has been accelerated by the current focus on vaccine production.

These new products are having a positive impact on the world, but the increased need for cold chain logistics and support comes with challenges.

Difficulties Associated with Cold Storage

Primarily, cold storage facilities are expensive to build and maintain. In addition to refrigeration equipment, such facilities require extensive security, building management/temperature monitoring, inventory management, and backup power systems. They also require skilled personnel both for facilities operation and maintenance and for regulatory compliance. 

This is where Sentry BioPharma Services and its offerings can reduce the burden for biopharma clients. Sentry provides FDA-compliant packaging solutions and supply chain management services to global pharmaceutical, biotechnology and medical device firms, and its diverse offerings protect product integrity throughout the pharmaceutical supply chain.

“Outsourcing allows smaller pharma companies with investigational or commercial products, or even large pharma companies with products in development with an uncertain future, to pay only for the cold chain storage services they need, for the period of time needed, without having to make their own investment in equipment and facilities,” explains Tim Mitchell, President / CEO of Sentry.

Sentry’s Cold Storage Offerings

To unburden biopharma clients of the demands imposed by cold chain storage, Sentry offers a full range of storage environments including refrigerated, frozen (-20°C, -40°C, -80°C and custom temperatures between -20 to -90°C), cryogenic temperatures at <-135°C, as well as controlled room temperature (+20 to +25°C) with controlled humidity. Sentry also offers labeling, kitting, and packaging services and provides distribution/transportation services through qualified vendors for commercial, clinical trial, or raw materials being sent to manufacturing sites.

“Prospective clients can engage Sentry at any stage of development and Sentry can provide a level of service appropriate to the particular stage of development,” says Alex Mitchell, Director of Operations at Sentry. “The process of engagement includes a discussion of services needed under conditions of confidentiality, provision of a quote which may be a response to a structured RFP, signing of a Master Service Agreement, Quality Agreement, and Statements(s) of Work detailing specific services to be provided, and a fee structure.”

“Sentry realizes ‘time is money’ in the industry, and takes great pride in its responsiveness to potential clients, and has previously completed this engagement process in as little as a week,” Tim adds.

In addition to the state-of-the-art equipment and systems at its facility, Sentry’s biggest asset for its clients, according to Tim, is its experienced personnel.

“Our people are instrumental in maintaining the high standards of service and regulatory compliance and their experience allows Sentry to assist its clients, particularly those with more challenging development needs, for example multi-site, multi-national clinical studies,” he remarks.

Whatever concerns clients may have, Sentry is able to rise to a variety of challenges.

“Clients expect, and must receive, timely services in compliance with regulatory requirements,” says John Warner, Executive Vice President at Sentry. “However, different clients have different needs that cannot be addressed by a ‘one-size-fits-all’ approach and these needs often change requiring responsive adaptation. Sentry provides what it believes to be extremely responsive services with communications and provision of troubleshooting and solutions as needed by its clients and according to their schedules.”

Overcoming Obstacles

According to Alex, the biggest hurdles for pharma companies are those over which Sentry does not have significant control, for example, conditions that may hamper or disrupt shipping and transportation, like weather or even civil unrest in certain countries. But Alex says Sentry assists its clients to be prepared for and to address such occurrences with its knowledge of sophisticated temperature-maintenance packaging, innovative shipping lanes, and electronic monitoring and tracking.

“Sentry’s facilities in the U.S. and Denmark are equipped with state-of-the-art redundant refrigeration equipment, security, building management/temperature monitoring, inventory management, and backup power systems. Sentry utilizes innovative technology such as vapor phase liquid nitrogen storage, the latest phase-transition shipping containers, and sophisticated electronic tracking and monitoring devices during shipping,” comments Alex. “For the most challenging of shipment lanes, Sentry uses advanced technology which pushes real time telemetry of critical data to Sentry. If a triggering event occurs, Sentry key personnel are alerted immediately via email and cell phone wherever they may be located around the globe.”

“Sentry provides critical services to meet its pharma clients’ cold chain needs and to facilitate and distribute vital medications globally,” states Tim Mitchell. “Everyday is new and exciting at Sentry as we protect drug product integrity while successfully negotiating the challenges presented by the everchanging global logistic landscape.”

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

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.

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

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. 

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

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.