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.”

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