RoSS.pFTU Lab-SCALE

Laboratory Freezer

RoSS.pFTU Lab Scale is a plate-based laboratory freezer for the controlled freezing of bioprocess containers up to 10 L.

Image of laboratory freezer RoSS.pFTU Lab-Scale for cGMP-compliant freezing & thawing, on a tranparent background.

Key Features

Controlled freezing down to -80 °C

Enabling highest possible speed and accuracy.

Up to 10 L per batch

Suitable for single-use bags up to 10 L, regardless of the manufacturer.

Single-use bag independent

Covering all available 2D bag vendors, types and sizes.

Best product stability results

Maintaining product integrity for mAb and other drug substances.

Automated and GMP-ready

Aligned with 21 CFR part 11

Optimal protection

Safe handling of single-use bags during freezing in combination with RoSS® shells.

Short lead times

Safe handling of single-use bags during freezing in combination with RoSS® shells.

Which applications is RoSS.pFTU designed for?

Single Use Support's plate-based laboratory freezer is the perfect solution for clinical studies conducted in labs and, above all, if you want to start a controlled and scalable cGMP freezing & thawing process.

The system is compatible with single-use bioprocess containers (both bags and bottles) of all sizes and manufacturers up to 10 L. Its small footprint helps you integrate it into your current workflows.

Our customers trust in us:

Downloads

Preview of datasheet for RoSS.pFTU Lab Scale freeze-thaw unit by Single Use Support

Datasheet

RoSS.pFTU Lab Scale - Datasheet

RoSS.pFTU Lab Scale - Datasheet
 
Preview of Single Use Support's whitepaper about controlled freezing with RoSS.pFTU

Whitepaper

RoSS.pFTU - Controlled scalable freezing - Whitepaper

RoSS.pFTU - Controlled scalable freezing - Whitepaper
 
Preview of datasheet for RoSS.pFTU scale overview by Single Use Support

Guide

Scale overview RoSS.pFTU - Guide

Scale overview RoSS.pFTU - Guide
 

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  • Thawing cells – process, difficulties & recommendations

    Cell thawing is a critical procedure in the area of life science and medicine. Ensuring a gentle thawing of frozen cells is essential for preserving their viability and functionality. In this article, we will highlight the cell thawing process, discuss common challenges, and provide recommendations for achieving optimal results in cell banking.  At Single Use Support GmbH, we understand the significance of safe cell thawing for preserving the integrity of valuable cell lines and primary cells. By employing single-use technology, our solutions for freezing, cryogenic freezing and thawing are designed to maintain high cell viability while streamlining the process to be automated and sterile, compliant with cGMP standards. Thawing cells: the process Both cell freezing and thawing have a direct effect on cell recovery rates and cell viability after thawing, two important quality aspects of cell culture. Whether you are working with primary cells, cell lines, or stem cells, it is essential to follow the correct steps to ensure successful thawing. In this section, we will provide a step-by-step process overview of thawing cells and compare the conventional process using cryovials with an advanced, automated process using a thawing platform and frozen single-use bags. 1. Preparation Gentle storage of the cryopreserved cells in an ultra-cold freezer and its timely transport to the designated thawing area are essential prerequisites for a smooth thawing process. For long term storage, liquid nitrogen storage is the recommended freezing medium. 2. Controlled thawing If cells are needed for studies or tests, they can be taken from the cell bank. For this purpose, the cells must be thawed. For frozen single-use bags, a 37°C/98,6°F water bath or CO2 incubator is commonly used to gradually thaw the cell suspension. Cell medium is added to the thawed cells immediately so that the previously added cryoprotectants (e.g. DMSO) are not exposed to room temperature but are effectively diluted. To protect the cells from sudden temperature shifts that may be harmful during thawing, a controlled thawing process is recommended to produce safe results. OR: Controlled thawing based on freeze-thaw platform Freeze-thaw platforms offer ideal conditions for both cell bank freezing and thawing. The step with manual thawing in the water bath is taken over by the platform in a controlled and automated manner. Human errors and product loss are reduced, while automated and documented processes ensure aseptic processing. Cells are frozen in single-use bags that are protected by a protective shell. The shell enables plate freezing technology performed with a freezing and thawing platform – where the single-use shells are cooled and frozen with a uniformly controlled temperature drop. When thawing, this process is reversed, with a controlled increase in temperature until the cell substance is in a liquid state again. 3. Cell viability assessment Post-thaw, accurate cell viability assessment is essential. Techniques like trypan blue staining can be employed to determine the proportion of viable cells in the suspension. 4. Seeding or Subculturing Depending on the research requirements, cells can be directly seeded into a culture dish or bioreactor or subcultured to propagate and maintain the cell line. Difficulties in cell thawing Thawing cells comes with its fair share of challenges that can impact the overall success of research work or the quality of the medicinal product. Knowing how to address these difficulties is essential to preserve the maximum quality of the cells. Some common challenges encountered during cell thawing are: Liquid nitrogen contamination: Contamination from liquid nitrogen during the cryopreservation process can affect cell quality and sterility, potentially compromising experimental integrity. Cell viability reduction: Too slow or too rapid thawing processes can lead to reduced cell viability, affecting experimental results and the success of upstream processing. In addition, there are studies that advocate shaking after thawing for quality improvement. Cell count inaccuracy: The process of thawing can result in cell loss, leading to inaccuracies in cell counts. This can impact subsequent experiments that require precise cell numbers. Inconsistent thawing: Uneven thawing within the cell suspension can result in variability in cell recovery and survival rates, leading to inconsistent results. Cell resuspension challenges: Thawed cells might be difficult to resuspend uniformly, leading to uneven distribution during subculturing or experimentation. Trypan blue misinterpretation: Misinterpretation of trypan blue staining during viability assessment can lead to inaccurate cell viability results, impacting data interpretation. To overcome these difficulties, careful attention to thawing protocols and best practices for specific cell types is essential. Computer-assisted, controlled thawing with automated platform systems ensures a gentle process and avoids human errors. Safe & efficient thawing in every scale with single-use technology Single Use Support takes the process of cell thawing to the next level – with innovative freeze-thaw platforms designed to process a wide range of cell culture volumes, from small-scale applications to large-scale production. Our cutting-edge single-use technology offers numerous advantages for achieving an optimized cell recovery rate and a high cell viability while streamlining the freezing and thawing processes. The platforms are designed and manufactured in compliance with cGMP guidelines, ensuring the highest quality and reliability for cell-based applications in research and medicine. While previously it was done in a water bath, we bring standardization to the process of thawing. By incorporating Single Use Support's freeze-thaw platforms into your cell culture workflow, operators can significantly enhance the efficiency and success of freezing and thawing processes. Achieving high cell viability, streamlining operations, and ensuring sterility are paramount for advancing research, bioprocessing, and cell-based therapies. References Use of liquid nitrogen during storage in a cell and tissue bank: Contamination risk and effect on the detectability of potential viral contaminants, http://dx.doi.org/10.1016/j.cryobiol.2011.12.005, Published 2011-12-28 Improving Cell Recovery: Freezing and Thawing Optimization of Induced Pluripotent Stem Cells, http://dx.doi.org/10.3390/cells11050799, Published 2022-02-25 Trypan Blue, https://www.sciencedirect.com/topics/biochemistry-genetics-and-molecular-biology/trypan-blue, Published 2012

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  • Plate freezing: best approach for freezing biopharmaceuticals in single-use bags

    Plate freezing is a process where a product’s temperature is reduced by the means of contact with cold surfaces. Thus, a defining step in the freeze-thaw process for conservation in flat primary packaging, such as single-use bags. Things to know about plate freezing techniques Although plate freezing is very commonly known in food production, this freezing process has proven equally indispensable for the biopharma industry. After all, it is to fullfill the same purpose in both fields of application: to freeze products for storage and transport in order to ensure maximum product quality – be it frozen food like fish fillets or highly delicate biologics like mRNA vaccines. How freezing techniques emerged Like many scientific discoveries, the advantages of freezing (then) food for shipment were found by chance: In general, cold environments have been used for ages in order to cool food with the aim to impede the growth of microorganisms. After all, it was in 1890 when, by accident, refrigerated meat that was being transported overseas from Australia to Britain got frozen. This had such remarkable results on the quality of the delivered food that the procedure of freezing has soon been widely adopted in food transport and storage. Later on, in the 20th century, quick freezing has shown to be advantageous for various kinds of food. Since its beginnings, refrigeration systems have undergone many steps of evolution and improvements – from the combination of salt brine and ice that products were induced in (a patent on this dates back to 1848’s Britain) up to high-performance automatic plate freezers. Alongside, freezing time has been optimized, freezing capacities expanded and new fields of application discovered. What freezing techniques are most counted on? The most frequently used freezing techniques are: brine freezing: A product is submerged in a brine that is additionally cooled by refrigerants. cryogenic freezing: Liquid nitrogen is applied on a product in order to instantly freeze it; this is a quick yet costly freezing procedure. A cryogenic freezer freezes down to -180°C/-292°F.  blast freezing: Products are put into an environment which is cooled by the means of cold air – a very common practice for bulk packaging, i.e. for ultra cold storage in laboratories. contact freezing (plate freezing): A product is frozen via direct contact with cooled surfaces like those of a contact plate freezer. Considering the different approaches in refrigeration with multiple challenges and benefits, a focus on the plate freezing process shall illustrate the huge potential and its key role in pharmaceutical production.   More about our Pharmaceutical Plate Freezer Plate freezer vs. blast freezer – the main differences for biopharma During the process of blast freezing, air is blasted in a cooling chamber on a product in order to set or keep it at low temperature; it is frequently chosen to create a cold storage for frozen items, conserving them over a longer time. Drug substances in bulky primary packaging, such as bottles or 3D bags are more mostly frozen in blast freezers. Plate freezing, on the other hand, relies on cooled surfaces themselves rather than a cooling air blast: Via direct contact with these freezing plates, heat transfer is induced between them and the yet to be frozen products, allowing quick freezing of drug substance between the two metal plates. In that a plate freezer requires the product to be touched by both surrounding surfaces, the shape of its containers is to be taken into account as well which is why this is the more suitable freezing technique for single-use bags. Advantages of plate freezing for biopharma As for biopharma, the use of a pharmaceutical freezer can be substantial e.g. on the attempt to exactly control the freezing time according to the requirements of the processed substance. Recipe-driven setpoints for product-tailored freezing allows standardization and reproducibility of freezing kinetics that meet GMP relevant quality standards. Plate freezers facilitate fast and controlled freezing of bulk drug substance in bags which has proven to significantly reduce the occurrence of cryoconcentration: Caused by the different solubilities of a product’s components, the ongoing emergence of crystals leads to the separation of certain ingredients. With fast plate freezing it is hence possible to minimize reduction of product quality by achieving high homogeneity in the liquids. Homogeneous freezing is a result from quicker heat exchange.   Freezing results in x-ray view As a result of a slow freezing process through conventional freezing techniques, such as a laboratory static freezer, larger crystals with proteins coagulate in the center of primary packaging which causes tensions that lead to diminishing product quality.  [[download-1-email-detailed]] Freezing solutions for biologics – from lab- to bulk-scale Acknowledging the many benefits of plate freezing in the production of high quality biologics, Single Use Support has developed an elaborate product lineup of freeze-thaw-platforms to address a wide array of applications with RoSS.pFTU (plate-based freeze-thaw unit) for single-use bags  and RoSS.BLST (controlled blast freezer) for single-use bottles and other bulky packaging. Having the choice between different sizes (from 100 mL up to more than 200L), customers are provided with the appropriate freezing solution for their very needs. From the use in studies conducted in labs with the small lab freezer for pharma up to bulk production of biopharmaceuticals, a fully scalable freezing option has been developed to ensure maximum product quality. Compatibility with single use bags of all sizes and manufacturers is given both in lab-scale and in large-scale freezing systems thanks to the secondary packaging with RoSS shells. These robust shells are a valuable complement to the reliable end-to-end solution provided by Single Use Support. More about the Freeze-Thaw Platform

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  • Advancements in Small Volumes Drug Freezing Techniques

    At the beginning of drug discovery you always deal with small volumes. Handling the cooling of drug substances in small quantities may seem straightforward, yet the intricacies involved are often more complex than anticipated. Traditionally, the use of a blast freezer or a liquid nitrogen tank has been a go-to solution. However, these methods are primarily designed for cryopreservation temperature maintenance and may compromise the viability of the product when employed for cooling down liquids from ambient to cryogenic temperatures. This is due to their inability to effectively balance the unique characteristics of the products during the freezing process. The significance of freezing small volumes extends beyond laboratory settings to include commercialized manufacturing processes for small batches. This is particularly relevant for applications like cell banking, gene therapies utilizing viral vectors, lipid nanoparticles, and fill & finish procedures. These processes lay the foundation for subsequent scaling, be it up or out, depending on market demands. Recognizing the nuanced requirements of different products and implementing tailored freezing methods is crucial for ensuring the integrity and effectiveness of drug substances, whether in the controlled environment of a lab or the dynamic realm of commercial production.   Freeze & Thaw Solutions Freezing methods for small volumes As already mentioned, there are three prevalent methods that are commonly employed for freezing small volumes of cells, biologics, and other active pharmaceuticals ingredients: Using a Blast freezer Using a Plate-based freezer Freezing in a LN2 tank In the context of blast freezers, achieving ultra-cold storage temperatures can be a time-intensive process. In some cases, the blast freezing method is deemed uncontrolled as operators cannot influence product related critical factors during freezing. However, there are controlled blast freezers that can control freezing rates overall and during phase transition to enable an ice growth based on the product's characteristics. On the other hand, liquid nitrogen emerges as a common choice for freezing small volumes of cells and other liquids in laboratory settings. Submerging liquids into a liquid nitrogen tank facilitates exceptionally rapid freezing for cryogenic storage below -150°C. Despite the time-saving advantages, this method carries a drawback concerning product quality for numerous drug substances. For instance, optimal cell viability post-thaw is achieved when cells are frozen at a rate of -1°C/min. The use of LN2 tanks for instant liquid freezing fails to align with the recommended freezing rate, potentially compromising the quality and effectiveness of the product. Careful consideration of the trade-offs between speed and quality is essential when selecting a freezing method. Each approach comes with its unique set of advantages and limitations, requiring a tailored choice based on the specific characteristics and requirements of the substances being frozen. Comparison of freezing techniques Blast Freezing Plate Freezing Liquid Nitrogen Freezer Liquid Nitrogen Tank (-80°C) (-80°C) (-170°C) (-190°C) Controlled freezing rates in bottles are adjustable for optimal product quality Controlled freezing rates in bags are adjustable for optimal product quality Controlled freezing rates in bags are adjustable for optimal product quality Uncontrolled exposure with too fast freezing Automated freezing with longer process duration Automated, controlled and fast freezing & thawing Automated, controlled and fast freezing & thawing Manual, not standardized process   Exploration of freezing in small volume applications Initiating the process of professional freezing and thawing for drugs cannot begin too early. Whether in the early stages of drug discovery or during the commercial production of small volumes, controlled freezing becomes an essential element in safeguarding the quality of drug products throughout the manufacturing journey. Several scenarios highlight the relevance of controlled freezing of small volumes: Working cell banks (WCB): Cell banks are required for many different areas of applications. Mammalian CHO cells are required for different cell-based therapies in biomanufacturing. This can be autologous cell therapies, such as CAR-T, or allogeneic cell therapies, emphasizing the need for meticulous control in the freezing process to ensure optimal cell viability. Cryopreserved HEK293 Cells for Viral Vectors: HEK293 cells are used as host cells for viral vectors – applied in gene therapies. The controlled freezing of these cells is vital to maintaining their integrity and functionality, ensuring the success of gene therapy applications. Non-viral vectors in vaccine production: Vaccine production involves the use of non-viral vectors such as Lipid Nanoparticles and plasmid DNA. Controlled freezing of these components is essential to preserve their efficacy, contributing to the overall success of vaccine manufacturing. Cell banking in seed train intensification: Employing controlled freezing in seed train intensification is a strategic approach to enhance bioprocess productivity and efficiency. The optimization of cell banking processes, especially focusing on achieving high cell density, is a decisive aspect for success in advancing upstream bioprocessing. [[download-1-email-detailed]] Transitioning to Precision with controlled rate freezing In pursuit of successful freezing across diverse applications, the key lies in attaining precise control. While liquid nitrogen tanks and most static freezers lack the flexibility to adjust freezing conditions according to the specific requirements of a product, the adoption of controlled-rate freezing and thawing methods emerges as a transformative approach in optimizing biopharmaceutical productions. One crucial concern in cold chain management, cryoconcentration, can be effectively mitigated through controlled-rate freezing. Cryoconcentration, characterized by the degradation of product quality due to protein aggregation, often results from the slow growth of the ice front in static freezers. This unwanted effect can be averted by implementing controlled-rate freezing techniques. The evolving interest in understanding a product's behavior during freezing has gained momentum, particularly in determining the cooling rate at which product viability is maximized. Controlled rate freezing addresses this need, offering tailored solutions such as plate-based freezing to -80°C or liquid-nitrogen-based controlled freezing platforms reaching temperatures as low as -170°C, catering to the specific demands of advanced therapies. For mammalian cells, optimal freezing rates typically range from -1°C per minute to -4°C per minute, reflecting their comfort zone during the freezing process. Recognizing and adhering to the preferred freezing rate is key in maintaining the viability and functionality of these cells. Do you know your preferred freezing rate? Advantages of plate-based freezing In addition to providing meticulous control over the freezing process to optimize product viability, plate-based freezing brings forth a host of further advantages, making it a preferred choice in the dynamic landscape of biopharmaceutical production. Flexibility amidst market dynamics: Volumes might change, size of single-use bags might change. Plate freezers offer a scalable platform that adapts seamlessly to the fluctuating demands of the market and varying volume requirements. Whether dealing with small milliliters or several liters, the scalability of plate freezers ensures adaptability to evolving market needs. Process control: The freezing platforms from Single Use Support are equipped with software that are suitable for GMP use. According to 21 CFR Part 11 it provides audit trails, reports and a full documentation of freezing history to grant for recipe-driven and standardized cold chain management. Product quality: The ability to control the freezing rate and ice front growth within the single-use bag translates to elevated product viability. This not only ensures higher product quality but also contributes to a more efficient production process and heightened patient safety. Independence from single-use bag vendors: Plate-based freezing excels in delivering scalable freezing performance, accommodating a broad spectrum of single-use bags and volumes, from as little as 10 mL to sizable 50L single-use bags, irrelevant of bag vendors and brands. Closed system: A robust and tamper-evident secondary packaging provides a sterile environment for all bags. This safeguards sterility throughout critical stages such as aliquoting, freezing, storing, and shipping, ensuring product integrity from production to delivery. Automation: The minimized manual intervention reduces the need for extensive documentation and validation, and shortens process cycles. This increased level of automation contributes to operational efficiency, making the overall production process more streamlined and responsive. Embracing the control over the freezing for small volumes The landscape of requirements for each novel therapy is in constant flux, particularly in the dynamic fields like commercial production for viral vectors and cell-based therapies. The freeze-thaw industry has undergone a transformation, and plate-based freezing emerges as the solution that empowers manufacturers to adapt freezing rates, processing volumes, and endpoint temperatures to align with the unique demands of their products. In the pursuit of new treatments, leveraging optimal outcomes is key to the success of Advanced Therapy Medicinal Products (ATMPs). While static freezers, and liquid nitrogen tanks persist due to historical usage, there exists a pathway to advance cold chain management towards efficiency and precision. Crucially, the controlled-rate freezing offered by plate-based systems holds the promise of not only efficiency but also a significant enhancement in product quality. The future of freezing and thawing small volumes unmistakably belongs to controlled-rate freezing. By embracing this innovative approach, we also embrace more efficient processes, improved product quality, and ultimately, the continued success of pioneering therapies. The time to advance the freezing and thawing for small volumes in biomanufacturing is now.   Discover our Freeze & Thaw Solutions

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