Why Should You Consider Reach-in Cold-Storage Options for Storing Biologics vs. Investing in a Cold Room Set-Up?

Why Should You Consider Reach-in Cold-Storage Options for Storing Biologics vs. Investing in a Cold Room Set-Up?

May 16th 2022

Market Drivers: Life Science and Pharmaceutical Products are Increasing

Cold storage is a mainstay in a wide variety of industry-specific applications such as for use in storing food and beverages, rare antiquities (books, art, and textiles), tobacco, and life science products. In some cases, they are even used to slow down chemical processes. Precise temperature control of certain drugs, biologics, and medical devices is required to prevent degradation and guarantee user safety. For example, medical application tools such as dental restorative materials and burn treatment products are highly temperature-sensitive and require consistent medical-grade refrigeration to maintain their effectiveness.

However, the explosion of newly developed mRNA-based products is one of the primary drivers influencing the biopharma market. Seen as somewhat of a trickle-down effect, the increase of temperature-sensitive drugs flooding the market is also forcing changes within the cold chain logistics industry. The global cold chain pharmaceutical production is forecasted to grow 48% between 2018 and 2024, vs. 27% growth in room-temperature pharmaceuticals, according to Pharmaceutical Commerce. There has also been a significant increase in the demand for ultra-low freezers. The global ultra-low temperature freezer market size was USD 547.0 million in 2019 and is projected to reach USD 783.1 million by 2027

The Pandemic Effect

Beginning with the unprecedented launch of the covid-19 vaccines, the door to bringing even more temperature-sensitive mRNA-based therapies to market is wide open with opportunity. Previously, mRNA research provided many challenges and questions about safety and efficacy. In fact, some of those concerns remain.

The use of messenger RNA (mRNA) therapy by systemic delivery to treat metabolic disorders has long been hampered by poor stability, immunogenicity, off-targeted delivery, and hepatic toxicity. However, in a shocking narrative twist, scientists seemingly pulled off the impossible and successfully repurposed existing mRNA agents into viable vaccine products. The vaccine manufacturers celebrated a monumental achievement as they gained fast-track-emergency FDA approvals which allowed the novel vaccines to be used in the coronavirus pandemic response effort.

Now, post-pandemic, the scientific community is realizing the vast potential of mRNA-based therapies. Current mRNA-based agents in development can be classified into three major application types based upon their mechanisms of action: prophylactic vaccines, therapeutic vaccines and therapeutic drugs. The research community is hopeful the new class of mRNA-based therapies can be a game-changer in treating poor-prognostic type conditions and diseases.

Market Statistics

  • -In August 2021, the gross capitalization value of mRNA products represented more than $300 billion.
  • -In July 2021, approximately 180 novel mRNA drug products entered the FDA approval pipeline.
  • -By 2023, temperature-controlled pharmaceuticals are expected to grow 59 percent from 2017 levels.
  • -Experts indicate a 48 percent expected growth rate between 2018 and 2024 for medicines that require a consistent temperature of 2 to 8 degrees Celsius during storage and shipping.
  • -Cold chain services (packaging, transportation and data services) are expected to significantly accelerate growth over the next three years, growing by 24 percent by 2024.
  • -In 2019, 45% of new drugs approved by the FDA required refrigeration or freezing.

Source Credit: Nature: Fig. 1 | Current profile of the mRNA technology pipeline. a | Proportion of companies among the 31 mRNA companies analyzed that have at least one candidate in the three main application areas, with the distribution of the 180 pipeline agents based on the therapeutic area shown to the right. b | Pipeline segmented based on application area and the phase of development. EUA, emergency use authorization. All pipeline information up to July 2021.


Cold-Storage Types: Reach-in vs. Walk-in

For pharmaceuticals, the FDA indicates current best practices for the housing of drugs and requires them to be stored “under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity of the drug products are not affected.” This objective put in motion by governmental regulatory agencies translates into the use of two primary medical-grade cold storage options: a walk-in style refrigeration unit OR a reach-in style medical-refrigeration/freezer unit.

Reach-in Medical-Grade Refrigerators and Freezers represent the most common type of cold storage used in clinical settings and laboratory environments. They are built specifically to help minimize temperature variances inside the unit and come in a myriad of sizes with different available options to choose from (I.e., chest, upright, countertop, undercounter, glass doors). Medical-grade refrigerators and freezers from K2 Scientific are designed with several state-of-the-art features including programmable microprocessor controllers, variable or smart defrost, durable, tight-sealing magnetic door gaskets, and adjustable high and low-temperature alarms to protect your valuable payload.

Walk-in Cold Storage Units come in a variety of different sizes and can be self-contained or part of another internal structure. Cold-storage walk-ins can be designed like a small bedroom-sized unit, or warehouse sized depending on the scope of items being housed. The design behind cold rooms that allows them to function efficiently isn’t so different from any other refrigeration system. Cold rooms and medical grade refrigerators and freezers both use a compressor, condenser, fans, and an evaporator to maintain the temperature within the room or unit. After a gas refrigerant gets compressed in the compressor it expands, and the gas absorbs energy. The hot gas flowing from the compressor passes over the evaporator coils and, after liquifying under high pressure, this cools the evaporator coils and the surrounding air. To maintain temperature, cold rooms must have a specific type of flooring and be well insulated.

Why Should You Consider Reach-in Cold-Storage Options Instead of Opting to Invest in a Cold Room Set-Up?

Pharmaceutical cold rooms have a distinctly designedis to house large amounts of temperature sensitive materials and live biological agents. Reach-in style medical-grade refrigerators offer consistent, reliable cold-storage, but at a fraction of the cost of manufacturing a designated room for cold storage. However, for certain industries, it makes perfect sense to adopt a cold-room style set up.

A good example of cold-room utilization is shown by, Direct Relief, a humanitarian organization which helps deliver medicine to vulnerable populations. As a part of their relief efforts, they erected a second cold room with 5,400 square feet of floor space, with racks rising three stories high and fully redundant refrigeration. Direct Relief’s existing cold storage room, a 2,900-square-foot facility that opened in 2018 at its California headquarters, is already at full capacity. The two rooms combined can hold up to 677 pallets of medicine for treating people with chronic conditions across the globe.

Source: Direct Relief

For small scale operations, you can get the same value and reliability in a reach-in medical-grade cold storage unit, but without the headaches associated with walk-ins. In hospital and laboratory settings, reach –in style laboratory grade refrigeration and freezers are preferred, however in some blood banks and larger scale biologic operations, both types are used.

Considerations for reach-in style laboratory and medical grade refrigeration include:

Portability

Reach-in style units offer several advantages in this respect. If a unit needs repair, then you only must service one unit and easily relocate the contents versus a system wide shut down which could take down an entire payload. They are also portable in the sense that they can be easily relocated to another location should the need arise.

Cost

The price point for stand-alone medical-grade cold-storage is significantly less expensive than the walk-in variety. They range from $1500-$10,000 and can offer up to 72 cu. Ft. of space per unit. Whereas the average cost of constructing even a small prefabricated cold room can be between $6000-$10000. A typical above ground unit is based on modular construction featuring fabricated metal panels with an R value of 34. HVAC units are installed inside, often situated near a metal pole barn to save on insulation, concrete and lumber. Electrical costs will also rise because of increased heat conduction gain. Total costs of such a unit are around $33,300, whereas a basement unit incurs upfront costs greater than $50,000.

Energy Efficiency

Refrigerated warehouses (cold storage facilities) have one of the highest electric energy consumption rates in the commercial building sector. Walk-in refrigerators and freezers can go anywhere from 15’ x 15’ units to units that span hundreds of thousands in square feet. Because of their size and the delivery, installation, maintenance, and energy costs that come with such large units, you need to do adequate research before investing in a walk-in style medical-grade refrigerator or freezer.

The U.S. Environmental Protection Agency (EPA) provides laboratory-grade refrigerator and freezer efficiency levels and product specification information on its ENERGY STAR website. Manufacturers meeting these requirements are allowed to display the ENERGY STAR label on complying models. Get a list of ENERGY STAR-certified laboratory-grade refrigerators and freezers.

Flexible Storage

The offerings for laboratory and pharmacy grade refrigeration have really expanded this past decade. The energy efficiency has improved in addition to the details that make the unit suitable for housing biologics such as temperature sensors, alarms, locks, and more. The most attractive feature are the selection types of high-performance refrigerators. They come in upright models, chest style freezers, combination, small footprint, and countertop styles making them easily retrofitted into any allotted cold-storage space.

What are some of the disadvantages associated with walk-In cold-room facilities?

Cold Storage Rooms Negatively Affect Battery Power

Another problem is that electric batteries do not like the cold temperatures. When operating in cold storage facilities, the average forklift battery can decline between 20% and 50% faster than it would in a room temperature warehouse environment. So, battery life can be substantially reduced.

That’s why electric forklifts that are used in cold storage warehouses often have higher voltage batteries. For example, when a forklift is fitted with a battery rated for 12 hours, even if the cycle reduction due to temperature is 25% it will still be operable for an 8-hour shift.

There is a remedy thanks to improved technology. Batteries used in cold storage applications can be optimized for cold environments. However, it adds an additional cost to an already hefty expense. Experts say to look for a battery with an electrolyte mixture specially designed for cold environments with corrosion-resistant plates and a high lead content. This combination will slow down battery degradation.

Cold-storage Facilities Are Not Simple to Construct

From the outside, cold storage facilities seem like large uncomplicated steel boxes. However, that perception is far from reality — they require an advanced, detailed analysis in the design phase to achieve significant operational cost savings. A cold storage facility works to maintain the stringent temperature requirements for the type of product it is housing, and to facilitate safe keeping for the anticipated storage duration. Significant thought is put into the insulation, wall, and floor types to help with energy conservation. As technology improves, the lean towards improving efficiencies have contributed to more complex cold-storage designs.

There are two different types of units - customized and prefabricated. Prefabricated units are typically less expensive because they have smaller design schematics.

How to Choose the Best Medical-Grade Refrigerator or Freezer Model for Your Outfit

Selecting a high-performance lab freezer, medical refrigerator ultra-low freezer begins by evaluating your perspective needs. Considerations may include content types, storage length, vessel type, and temperature requirements. Other details might also come into play such as, where the unit will be situated and serviceability. It is not uncommon for large-scale pharmaceutical endeavors to use both (walk-ins and reach-ins) to manage their payloads.

Large-scale entities like UPS Health, act as cold-chain logistics provider, making the use of a cold-storage warehouse facility is a must. Pharmaceutical packing company, Reedlane, also utilizes a cold-storage warehouse because they are housing thousands of biological samples as an intermittent storage facility until the pharmaceuticals are packaged and shipped to their intended designation. For most clinical settings, traditional-style medical refrigeration is the gold standard. We are also noticing a trend towards solar-power vaccine refrigerators to help serve vulnerable populations where power and supplies are limited.

For blood banks, hospitals, and other clinical environments, laboratory-grade refrigeration is the preferred method of cold storage. Statistics indicate that blood bank refrigerators will see the most growth of all other cold-chain storage options combined, and is expected to reach US$ 3,096.6 Million by 2027.

For more information, please contact K2 Scientific.

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