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Adding value

We work with our partners to deliver knowledge-based solutions. In doing so, we always strive to improve the process and add value to the chain. For example, by achieving higher efficiency in terms of purity, delivery reliability or yield of medicinal products per liter of plasma.

Thanks to this solution-driven approach, Prothya Biosolutions has become the largest CDMO partner in the blood plasma industry.

Services

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Product/process development

  • Develop processes, parameters and attributes (QbD methodology)
  • Assess viral safety
  • Develop formulations
  • Evaluate plasma product stability
  • Develop and pre-validate analytical method
  • Characterize plasma and plasma products
  • Industrialize process
  • Validate single use devices
  • Control process limits, stability and capability
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Contract manufacturing

  • Plasma intermediates valuation for industrial manufacturing
  • Plasma intermediates valuation and handling
  • Offer and expand manufacturing capacity
  • Tailored production process
  • API, drug substance, drug (bulk and final) product manufacturing
  • Audit readiness – EMA, FDA and national authorities
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Plasma operations

  • Assess and audit blood establishments (recovered and apheresis plasma)
  • Transport and storage of plasma
  • Prepare plasma for industrial manufacturing
  • Support national self-sufficiency plans
  • Framework tolling activity
  • Dedicated supplier and customer relations