January 20, 2020

Lab freezer for single use technology

Biopharmaceutical manufacturers are increasingly utilizing single use technologies for cold storage, shipping in the cryogenic temperature range and the transfer of biopharmaceutical substances and reagents under strict temperature control. The advantages speak for themselves:

By abandoning cost-intensive, outdated, and bulky lab equipment such as auto defrost solid door upright freezers, conventional manual defrost chest freezers, and ultra-low temperature freezers, manufacturers can save considerable amounts of USD and increase productivity considerably for each cu ft of plant space.

Single use technologies, and single-use bioprocess containers in particular, require little storage space, which makes them a cost-effective solution. Additionally, bags of different sizes are freely available on the market and, where required, established and standardized quality tests are available to be conducted before filling and use.

Recently, the COVID-19 pandemic highlighted a weak point in the life science and biopharma business: refrigeration, freezing and cold temperature technology in general. With the need to manufacture massive amounts of vaccine vials with unprecedented storage requirements, the bottleneck of vaccine storage and transport emerged. This situation challenged innovative companies to develop benchtop solutions to overcome lab refrigerators and freezers.

ross-pftu-labscale

RoSS.pFTU Lab-Scale

Compatible with single use bags of all sizes and manufacturers. Our lab scale freezer is the perfect solution for studies conducted in labs and, above all, if you want to start a controlled and scalable freezing process.

freeze-thaw-technology-handlings-mabs-another-quality-level

Freeze & Thaw platform

The Single Use Support freeze-thaw platforms provide insular solutions for the freeze/thaw processes of each clinical phase. Our new freeze-thaw units are fully scalable and compatible with all batch sizes and bags from all established manufacturers – you will only require one single system from the lab to blockbuster production.

laboratory-freezer-susupport

But the advantages of single use technology do not end with the storage: The entire handling of the logistics process for biopharmaceutical liquids is fool-proof, especially when compared to the utilization of stainless-steel tanks, Cryo vessels and other traditionell alternatives. With the use of single use technologies, cleaning, storage as well as complicated logistics can practically be omitted.

Where the water volume as well as chemical detergents required when using stainless-steel solutions are significant and far from being sustainable, single use technology is leading the way in terms of sustainability.

All these factors apply to established manufacturing as well as the production of small batches conducted in labs or for study purposes with conventional methods such as chromatography, countertop centrifuges, PCR, pipettes, and electrophoresis.

The advantages of compact plate freezers over laboratory freezers

Humans are simple beings. So it seems just plausible to use a general purpose compressor fridge or laboratory freezer for freezing liquids such as culture media. But things are not always as simple as they may appear. While the use of laboratory refrigerators and low freezers may be logical, the outcome is far from the optimum and usually unsatisfactory. Traditional defrost freezers have disadvantages that can be clearly measured:

  • Unreliable thermostats, lack of digital controls, timers, microprocessor control, touchscreens
  • A lengthy freezing process for liquids
  • The formation of relatively big crystalline structures caused by the slow and not very homogenous freezing process, which are the cause of frictions that lead to the destruction of valuable proteins. Up to 20% of proteins can be destroyed like this. Effect: After thawing, the substance has lost a considerable amount of its original concentration, thus dropping in value.
fast-freezing-vs-slow-freezing

At first it may feel unfamiliar to place a microplate or filled single use bag in a compact plate freezer, which seems to resemble a toaster rather than a freezing device.

However, appearances don’t matter as long as the outcome doesn’t fail to convince:

  • The speed of the freezing process is multiplied: Thanks to the close contact of the freezing plates and the liquid there is no more need to freeze air used for isolation. The cold gets directly transferred, thus saving time and energy.
  • The shock-like freezing retains the quality of the substance, from small molecule drugs to enzymes and monoclonal antibodies. Due to direct contact with the freezing plates on both sides, the container is frozen consistently and evenly, as seen in the image. A condensed line is visible in the bag’s mirror axis, indicating a homogeneous freezing process.

The construction and functionality of a plate freezer for lab use is demonstrated in this video. The filled single use bag is integrated in the RoSS Shell System specifically developed by Single Use Support to offer protection and security against manipulation, while at the same time facilitating an ideal temperature transfer for the freeze/thaw process in plate freezers.

The advantages of single use bags and the entire single use technology for labs are evident: Single use technology is financially attractive, flexible and easy to handle, yet it offers the highest degree of system compatibility in terms of partner and manufacturer interfaces as well as the internationalization of processes.

Why is a scalable freeze/thaw concept more attractive for labs than small lab freezer racks?

At some point in time any successfully tested product will outgrow the lab. It is ready for market – but what now? Do all processes need to be newly scaled? Do all platforms need to be newly validated?

Single Use Support simply says: NO

If required, a lab-scale platform can be upscaled to small-scale and to blockbuster production without having to newly define processes or obtain FDA and other validations – either for one or across several sites.

RoSS Shell (single-use bags protection system) is a compatible and flexible interface that works with any single-use bag, no matter what brand or volume you prefer or require.

If you had to illustrate a sustainable and smooth, scalable process for a new biopharmaceutical product, RoSS.pFTU lab scale would be the only viable solution.

What is more, Single Use Support’s lab scale also offers a compact freeze-thaw system for rent.

Conclusion: All advantages speak for themselves. Single use technology is clearly on the rise. The system is scalable and the initial costs can be lowered further with our rental option. Compared with lab freezer costs when buying equipment or lab freezer rental, Single Use Support’s seamlessly scalable freeze/thaw platform is simply more cost-effective and an alluring option. It does not require any further validations for an upgrade of batch sizes.

More solutions

ross-pftu-mid-scale

RoSS.pFTU Mid-Scale

Our mid scale freezer is a plate-based Freeze/Thaw unit designed for RoSS shells, to protect your preferred single-use bag during cryogenic applications. 

RoSS.pFTU mid scale is compatible with single-use bioprocess containers of all sizes and manufacturers and shows best product stability results for your biopharmaceuticals up to 70L. 

ross-pftu-large-scale

RoSS.pFTU Large-Scale

Our large scale freezing platform system is a plate-based freeze-thaw unit for any scale and batch size. Well-established RoSS.pFTU large scale is compatible with single-use bags of all sizes and manufacturers. The hybrid solution offers freeze-thaw capabilities for bags and bottles up to 220L in one platform.  

ross-frig-cold-storage-fridge

RoSS.FRDG | Cold Storage Refrigerator

RoSS.FRDG is a storage fridge for frozen drug substances in different sizes. It keeps the desired set point temperature down to -80°C. RoSS.FRDG is compatible with RoSS Shells, stackable itself, fully moveable and shippable. 

ross-shak-shaker

ROSS.SHAK | Shaker

RoSS.SHAK is your reliable shaker to regain highest quality and homogeneity of your biopharmaceuticals.

RoSS.SHAK enables constant shaking of your protein to regain homogeneity and product quality after freezing. Shakes up to 70L per run in 3 pre-defined speeds.

ross-padl-scaled

RoSS.PADL | Homogenizing Solution

RoSS.PADL is a scalable platform for cooling your single-use bag whilst gently massaging it to ensure there is a homogenous mixture of the solution. With the RoSS.PADL multiple cooling and massaging mechanisms can be placed side by side with one control system.

lab-freezer-single-use-technology

Michael Eder

Business Development / Marketing Manager

micheal-eder