Human Plasma-Derived Therapeutics


Human plasma-derived therapeutics originate from human plasma instead of the chemical or synthetic materials from which most pharmaceuticals are made.

Capable of fractionating millions of liters of human plasma into a wide variety of therapeutic products, today’s plasma fractionation plants are large and complex. As human plasma-derived therapeutics become more widely used to boost the immune system, fight infections, reduce inflammation and treat rare and/or chronic diseases like hemophilia, genetic COPD, von Willebrand Disease and blood disorders, pharmaceutical companies look to CRB’s subject matter experts for their expertise in immunoglobulin and antibody manufacturing, specifically subfractionation, purification and fill finish operations that are vital to modern plasma fractionation plants.

Expertise in these areas includes the following processes and equipment:

  • Subfractionation
    • Critical temperature control
    • Solvent concentration
    • Filter presses or centrifuges
  • Purification
    • Ultrafiltration
    • Nanofiltration
    • Chromatography
    • Germ-reduction filtration and chemical treatment
    • Viral reduction step(s)
  • Fill finish
    • Sterilizing filtration
    • Critical filling operations
    • Isolators
    • Depyrogenation ovens
    • Autoclaves
    • Stopper/vial preparation equipment
    • Capping equipment, cartoners, boxers, palletizers and labelers

With innovative solutions being developed in the design of both bulk processing facilities and equipment, CRB adds value to your project by implementing the following strategies:

  • Take a risk-based approach to cleaning process-dedicated equipment
  • Increase process closure to decrease or eliminate environmentally classified space
  • Minimize operator interventions and improve ergonomics
  • Increase process analytical technology to streamline or eliminate in-process testing
  • Introduce disruptive technologies, such as changing separation techniques to systems that are easier to clean
  • Adapt a single-use product path to eliminate clean-in-place, steam-in-place, clean-out-of-place and steam-out-of-place systems for product contact parts
  • Launch campaign manufacturing to eliminate isolator vaporized hydrogen peroxide between batches
  • Enhance sterility with continuous microbial monitoring as an alternative to plates
  • Eliminate operator interventions by using gloveless isolators
  • Design filling lines to allow for retrofit of alternative dosing systems
  • Inspect vial contents for particulates prior to lyophilization
  • Use mobile vessels local to filling machines to eliminate hard piping
  • Shift from batch to continuous formulation and filling
  • Scale out filling operations instead of scaling up
  • Use robotics to eliminate human intervention

CRB has a thorough understanding of the international regulatory environment and the impact process design has on facility startup and process validation. Standard practices include CGMP-oriented documentation and change control procedures that facilitate a smooth transition from design to validation. It is imperative that the standardized design meets the expectations of the regulatory agencies. CRB has subject matter experts who are proficient in regulatory guidelines and the Annex 1 revisions and can help you make decisions that will save time and money in planning for the future.

Contact a CRB plasma fractionation subject matter expert today for more information.


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