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    Processing of blood plasma
    Processing of blood plasma derivatives

     

     

     

    Blood plasma fractionation

    Human blood plasma is being processed for a wide range of indications today thanks to pharmaceutical research and increasingly powerful fractionation technologies. The rise in global diseases, such as immunodeficiencies and genetic defects, is further fueling demand. Manufacturing companies must produce large quantities of high-quality and safe medicines to meet this global demand.

    Facts

    More than half of human blood consists of plasma. So-called plasma derivatives – drugs derived from human plasma – utilize the versatile properties of this carrier substance. Rich in proteins, antibodies, and clotting factors, plasma is the starting point for many therapies.

    Notable proteins include albumin, immunoglobulins, and fibrinogens:

    • Albumin
      Supports the treatment of serious injuries
    • Immunoglobulins
      Antibodies – are used to prevent or treat tetanus, rabies, or hepatitis
    • Fibrinogen-based products
      Ensure that blood can coagulate again

    Blood fractions

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    What makes blood plasma such a valuable product?

    Rising global demand

    Rising global demand
    Globally rising demand for plasma derivatives through an increase in immune diseases, coagulation disorders, and genetic defects.
    Endogenous

    Endogenous
    Plasma is largely generated by the body itself and is difficult to produce chemically or biopharmaceutically.
    Donor shortage

    Donor shortage
    Up to 1,000 donations are required to treat one patient for one year.
    Temporal aspects

    Temporal aspects
    Time-consuming: production of plasma derivatives takes between 7 and 12 months.
    Financial aspects

    Financial aspects
    Collecting plasma is time-consuming and expensive.

    The extraction and processing of blood plasma derivatives

    Extraction and processing of the blood

    Pharmaceutical companies extract components from raw human plasma using centrifugation, depth filtration, and chromatographic methods. This rare and expensive resource requires efficient manufacturing processes to turn every drop of plasma into an effective and safe drug. 

    To this end, companies use elaborate processes ranging from thawing and filling to freeze-drying or pasteurization. Syntegon's highly flexible technologies cover key requirements along the entire value chain:

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    Thawing
    Thawing

    Our systems for thawing frozen blood plasma ensure gradual thawing of shear-sensitive products.

    Formulation_01
    Formulation

    Based on decades of experience, Syntegon offers efficient systems for the synthesis and formulation of plasma derivatives, vaccines, and oncology products.

    Inspektion
    Inspection

    Syntegon inspection systems cover visual inspection and leak testing (CCIT) – from inline to end-of-line solutions.

    pasteurization
    Pasteurization

    Thanks to flow-optimized systems, our pasteurizers ensure consistently stable temperatures during final pasteurization of plasma derivatives.

    Filling
    Filling and closing

    Our flexible platforms ensure safe filling of sensitive proteins in the low, medium, and high output range.

    Internal manifolds
    Freeze drying

    Our freeze dryers ensure homogeneous temperatures, while the patented loading and unloading system enables precise processing and lyophilization.

    Fractionation
    Fractionation and purification

    Syntegon offers proven ultrafiltration, depth filtration, and chromatography systems to support the separation of blood plasma. We provide a comprehensive portfolio of viral inactivation and final purification options, including thermal inactivation and multi-stage enzyme purification.

    Fraktionierung

    Thawing and fractionation

    The Syntegon subsidiary Pharmatec offers thawing and fractionation solutions for raw plasma that are tailored to meet customer-specific requirements. With decades of experience and high standards in design and implementation, the company ensures precise and efficient processes. These include special thawing systems with low shear agitators, centrifuges, and filtration systems. All our systems are designed for efficient processes and are easily accessible for maintenance and cleaning. Common CIP/SIP systems enable the economic use of resources and cleaning media through recirculation. Our pure media systems also offer the highest flexibility regarding sanitization methods. Moreover, Pharmatec can integrate both CIP/SIP and NaOH units for plasma production thanks to its extensive system expertise.

    Formulation_01

    Purification and formulation

    Pharmatec uses established equipment from its own portfolio along with high-performance units from partner companies to purify plasma fractions and other products. The company also offers a wide range of technologies for virus inactivation and final purification. The subsequent formulation prepares the sensitive fractions for further processing, where maintaining the quality of plasma derivatives is paramount. All solutions from Pharmatec are fully automated, allowing for continuous monitoring of all quality-critical parameters. Pharmatec process systems have either integrated or external CIP/SIP systems with PW, WFI, PS, which can be adapted to the specific application. Pharmaceutical companies receive comprehensive consulting services, which include laboratory testing of the required systems and processes. This also includes developing a tailor-made maintenance strategy.

    Filling

    Filling and closing

    Syntegon’s innovative filling systems provide flexible filling operations in the low, medium, and high output ranges – in a compact design with integrated isolator. ALF lines accommodate different filling technologies on one platform: while the time-pressure filling system is suitable for high-volume filling, the peristaltic pump with up to 12 filling stations enables gentle and precise dosing of shear-sensitive products. Thanks to the optional twin fill process from the new “Max Pro” portfolio, the filling weight can be optimally determined and readjusted via main and secondary dosing with 100% in-process control at any time, ensuring maximum product yield. Optional secondary dosing, dose-in, and dose-out as well as empty runs on a scale contribute to a high yield and enable retroactive plunger insertion.

    LM200 with lyogistics zero and open gimbal-door

    Freeze drying

    Telstar's pharmaceutical freeze dryers offer unmatched quality with the perfect mix of standardization and customization. With multiple configurations available, there will be a solution that fits your needs. The Telstar brand has experience managing a wide range of container sizes and formats which guarantee the best production assurance. Our freeze dryers are ideal for small and large batch production: from 1 to 60 m2, under isolator or RABS, and connecting with filling lines with different loading and unloading solutions.

    Benefits:

    • Seamless integration with upstream and downstream equipment through harmonized interfaces, components, and documentation.
    • One or two-story configurations.
    • Cold shelf loading down to -45ºC without compromising loading speeds.
    • Single side or passthrough loading and unloading available.
    • Internal workshop to assure the best pressure vessel quality, including the shelf stack.
    Inspektion

    Inspection

    High quality plasma derivatives with as few false rejects as possible require state-of-the-art inspection technologies. Syntegon offers a comprehensive range of in-line and end-of-line solutions for a wide variety of vial formats. Syntegon inspection systems provide reliable inspection of liquid and lyophilized products to detect leaks, particles, and cosmetic defects. Modern machines such as the AIM5 series combine visual inspection and leak detection (CCIT) on one platform. The Static Division (SD) technology accurately identifies foreign particles within products, while leak detection is performed via Headspace Analysis (HSA).

    pasteurization

    Pasteurization

    Based on detailed simulations, the Syntegon subsidiary Schoeller-Bleckmann Medizintechnik (SBM) designs systems for pasteurizing blood plasma derivatives using different processes, such as steam/air mixture or hot water shower, to ensure the best process for each product. Thanks to precisely adjustable process parameters and a constantly stable temperature of 60 (+/- 0.5) degrees Celsius, the pasteurization process can safely handle sensitive plasma proteins such as albumin without denaturation. A flexible recipe editor allows for individualized processes – resulting in products that fully meet the applicable quality criteria.

    Interested in our pharma solutions?

    Interested in our pharma solutions?

    Contact our experts to learn more about Syntegon’s processing and packaging solutions.

    Contact us

    Our solutions

    2-Syntegon_SBM_FreezeDryer
    Freeze dryer

    Our freeze dryers ensure homogeneous temperatures, while the patented loading and unloading system enables precise processing and lyophilization.

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    aseptic-filling-line
    Filling systems

    Our flexible platforms ensure safe filling of sensitive proteins in the low, medium, and high output range.

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    isolator_1
    RABS & Isolators

    Our barrier systems include open RABS, closed RABS, isolators and containment systems.

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    ampoule-inspection
    Inspection

    Syntegon inspection systems cover visual inspection and leak testing (CCIT) – from inline to end-of-line solutions.

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    process-sterilization-pharmaceutical
    Sterilizer/Pasteurizer

    Thanks to flow-optimized systems, our pasteurizers ensure consistently stable temperatures during final pasteurization of plasma derivatives.

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