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    Home > Events >Applications of Controlled Freeze &Thaw Systems in Production of Biologicals

    Applications of Controlled Freeze &Thaw Systems in Production of Biologicals

    With the development of the pharmaceutical industry, medical care and public health has become an important part for the safety of human life. With a rapid development of biomedicine in the pharmaceutical industry, biologicals have become an increasingly important treatment.

    When biologicals are exposed to inappropriate conditions that are not effectively controlled during the production, the quality will be affected, which will endanger the lives of patients indirectly. For biologicals stored in a form of solution, the effective storage of raw materials and intermediates is very essential. For heat-sensitive biologicals(such as mAb, vaccine,blood plasma,insulin,probotics,growth hormone,etc.),cryogenic preservation can ensure the biological activity, and it is an effective and economical way in the current biopharmaceutical industry.

    Generally, liquid biologicals are stored in an ultra-low temperature refrigerator or freezer at -40 to -80°C, and thawed through a water bath circulator at about 25°C or at room temperature (25°C). Traditional freezers and thaw biologicals containers are stainless steel or PE bottles or Barrels.

    The Problems of  Traditional Freezing & Thawing Methods

    The freezing and thawing rates are uncontrollable and cannot be repeated later;

    ?   The freeze & thaw distance (thickness) is different, and its process cannot be scaled up and controlled later.

    ?   The liquid loading and unloading is performed under an exposed condition;

    ?   There is lack of regulatory compliance (no electronic signatures, no electronic records, etc.).

    The Disadvantages & Risks of Traditional Freezing & Thawing Methods

    The products or intermediates have low homogeneity, the biologicals have poor stability, and their quality has changed, with reduced 

    With the development of the pharmaceutical industry, medical care and public health has become an important part for the safety of human life. With a rapid development of biomedicine in the pharmaceutical industry, biologicals have become an increasingly important treatment.

    When biologicals are exposed to inappropriate conditions that are not effectively controlled during the production, the quality will be affected, which will endanger the lives of patients indirectly. For biologicals stored in a form of solution, the effective storage of raw materials and intermediates is very essential. For heat-sensitive biologicals(such as mAb, vaccine,blood plasma,insulin,probotics,growth hormone,etc.),cryogenic preservation can ensure the biological activity, and it is an effective and economical way in the current biopharmaceutical industry.

    Generally, liquid biologicals are stored in an ultra-low temperature refrigerator or freezer at -40 to -80°C, and thawed through a water bath circulator at about 25°C or at room temperature (25°C). Traditional freezers and thaw biologicals containers are stainless steel or PE bottles or Barrels.

    The Problems of  Traditional Freezing & Thawing Methods

    The freezing and thawing rates are uncontrollable and cannot be repeated later;

    ?   The freeze & thaw distance (thickness) is different, and its process cannot be scaled up and controlled later.

    ?   The liquid loading and unloading is performed under an exposed condition;

    ?   There is lack of regulatory compliance (no electronic signatures, no electronic records, etc.).

    The Disadvantages & Risks of Traditional Freezing & Thawing Methods

    ?   The products or intermediates have low homogeneity, the biologicals have poor stability, and their quality has changed, with reduced activity and safety;

    ?   There is risk of microbial contamination;

    ?   The biologicals have shortened shelf life;

    ?   The production cost increases and the production efficiency decreases.

    However, the traditional freezing and thawing method is still used by most biopharmaceutical companies, mainly because of the cost.

    The Development of Controlled Freeze &Thaw Systems

    When the biologicals are transformed from the R&D stage to the commercial large-scale production stage, biopharmaceutical companies have to consider the following: how to guarantee the consistency of process scale-up and how to increase the production capacity during commercial production.

     First of all, biopharmaceutical companies need to consider the matching of the capacity of the freezing steps with the upstream and downstream. Secondly, biopharmaceutical companies need to minimize production costs and improve efficiency while guaranteeing the product quality and safety. Although traditional methods are still widely used in the R&D of modern biopharmaceutical industry and can achieve some effects, the traditional freeze & thaw methods need to increase the labor works, enhance the risk of product contamination and add a complex validation process after the products have entered the clinical and commercialization stages.

    The controlled freeze& thaw systems integrates freezing and thawing

    processes. This system is different from the traditional ultra-low temperature refrigerator and water bath circulator. By using the controlled

    freeze &thaw method, the system can provide liquid biologicals, especially biological macromolecule intermediate with controlled (timely feedback 

    With the development of the pharmaceutical industry, medical care and public health has become an important part for the safety of human life. With a rapid development of biomedicine in the pharmaceutical industry, biologicals have become an increasingly important treatment.

    When biologicals are exposed to inappropriate conditions that are not effectively controlled during the production, the quality will be affected, which will endanger the lives of patients indirectly. For biologicals stored in a form of solution, the effective storage of raw materials and intermediates is very essential. For heat-sensitive biologicals(such as mAb, vaccine,blood plasma,insulin,probotics,growth hormone,etc.),cryogenic preservation can ensure the biological activity, and it is an effective and economical way in the current biopharmaceutical industry.

    Generally, liquid biologicals are stored in an ultra-low temperature refrigerator or freezer at -40 to -80°C, and thawed through a water bath circulator at about 25°C or at room temperature (25°C). Traditional freezers and thaw biologicals containers are stainless steel or PE bottles or Barrels.

    The Problems of  Traditional Freezing & Thawing Methods

    The freezing and thawing rates are uncontrollable and cannot be repeated later;

    ?   The freeze & thaw distance (thickness) is different, and its process cannot be scaled up and controlled later.

    ?   The liquid loading and unloading is performed under an exposed condition;

    ?   There is lack of regulatory compliance (no electronic signatures, no electronic records, etc.).

    The Disadvantages & Risks of Traditional Freezing & Thawing Methods

    ?   The products or intermediates have low homogeneity, the biologicals have poor stability, and their quality has changed, with reduced activity and safety;

    ?   There is risk of microbial contamination;

    ?   The biologicals have shortened shelf life;

    ?   The production cost increases and the production efficiency decreases.

    However, the traditional freezing and thawing method is still used by most biopharmaceutical companies, mainly because of the cost.

    The Development of Controlled Freeze &Thaw Systems

    When the biologicals are transformed from the R&D stage to the commercial large-scale production stage, biopharmaceutical companies have to consider the following: how to guarantee the consistency of process scale-up and how to increase the production capacity during commercial production.

     First of all, biopharmaceutical companies need to consider the matching of the capacity of the freezing steps with the upstream and downstream. Secondly, biopharmaceutical companies need to minimize production costs and improve efficiency while guaranteeing the product quality and safety. Although traditional methods are still widely used in the R&D of modern biopharmaceutical industry and can achieve some effects, the traditional freeze & thaw methods need to increase the labor works, enhance the risk of product contamination and add a complex validation process after the products have entered the clinical and commercialization stages.

    The controlled freeze& thaw systems integrates freezing and thawing processes. This system is different from the traditional ultra-low temperature refrigerator and water bath circulator. By using the controlled freeze &thaw method, the system can provide liquid biologicals, especially biological macromolecule intermediate with controlled (timely feedback  and revise for the application of process analysis techniques), repeatable (freezing and thawing of products with the same specifications, process scale- up from R&D to the commercial production), and powerful (efficient cold and heat exchange technology) freeze&thaw environments. The controlled freeze & thaw system can not only reduce the risk of microbial contamination, but also effectively extend the shelf life of the product while guaranteeing the product quality and stability.

    Tofflon Controlled Freeze & Thaw Systems

    Tofflon has independently developed the controlled freeze & thaw systems (horizontal type and vertical type as shown in Figure) based on its experiences in the shelf high-efficiency heat exchange (refrigeration, heating) and the application needs on the biological markets. Its freezing effect and its features as below:


     Horizontal Freeze &Thaw Systems

    Vertical Freeze &Thaw Systems

    ?   Reliability & Stability

    Stability and reliability are the most basic requirements for equipment. The

    equipment should be able to run stably and reliably for a long time (not less than 24h). Only by this way can we ensure that the production can be carried out normally without failure in the production process.

    ?   Personnel Safety

    The equipment has a good human-computer interaction environment and complete safety protection measures (such as safety interlocks, safety warnings, etc.), to ensure that the equipment will not cause harm to people during the operation.

    ?   Product Safety

    Selection of disposable liquid storage bags: Confirm that the manufacturer has a complete quality assurance production system (to ensure that the bags produced are qualified) and has completed the bag integrity test, materials confirmation and compatibility test, E/L (extracts) safety assessment, etc.;

    Freeze&thaw process: Reasonable control of the freeze&thaw distance, product formulation, and control of safety measures during the upstream and downstream transfer process.

    ?   Compliance:

    ü  GMP compliance (consideration on equipment);

    ü  Have audit trail function, that is, software compliance (compliant with FDA 21 CFR PART 11);

    ü  GMP compliance during production (e.g. audit trail of biological products during the long-distance transportation);

    ü  Validations (equipment validation, instrumentation validation);

    ü  Compliance of the document system (consideration of completeness);

    ?   Process compliance

    ü  Process development (develop the process control suitable for research and development, pilot scale-up, and commercial production based on the layout of product research and development pipelines);

    ü  Comparative study of the impact of different factors on the product quality in the production process;

    ü  Develop and explore the freeze-thaw rate interval in the controlled freeze-thaw system based on different products.

     ?   Comparison of horizontal freeze&thaw system sand vertical freeze & thaw systems

    Item

    Horizontal

    Vertical

    Loading quantity

    100 L

    100 L

    Quick freezing: room temperature to -40℃

    5h

    4.5 h

    Re-thaw: -40℃ to room temperature

    6h

    3.5 h

    Clamp

    Swing

    ×

    Remove bubbles

    ×

    Temperature validation

    Very convenient

    Convenient

    Loading

    Convenient

    Very convenient

    Customization

    ×

    ((()Table :  Comparison of performance of horizontal type freeze&haw systems and vertical type freeze&thaw systems (solution: water)

    With the fierce competition in the biopharmaceutical industry, biopharmaceutical companies will meet the challenges of improving quality, reducing risks and investment and improving the efficiency in the rational layout of research and development pipelines. We believe that the controlled freeze&thaw systems independently developed by Tofflon will play an important role in the development of biologicals.

     

     

     

     

     

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