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WHAT WE OFFER

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Human Plasma Infrastructure & Testing Solutions

  • Blood Banks & Apheresis Center Setup 

  • Fresh Frozen Plasma (FFP) Bank

  • Plasma Qualification & Testing Laboratories (NAT, ELISA, QC & QA) 

  • Pooled Plasma Lab Setup for Fractionation Input

  • Know more about plasma bank  Plasma Fraction.com

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Global Regulatory Compliance

  •  US-FDA 21 CFR Part 11 (Data Integrity & E-Records) 

  • EU-GMP, UK-MHRA, WHO-GMP, PICS Standards 

  • Validation Support – IQ/OQ/PQ, Cleaning, HVAC, Equipment 

  • Tech Transfer, SOPs, Dossier & CTD Preparation

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CRO/CMO Services

  • Biological CRO Labs for R&D, Stability, and Validation 

  • CMO Facilities for Injectable Drugs & Bio-Ingredients 

  • End-to-End Batch Documentation & Compliance.  

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Plasma-Derived Medicinal Products (PDMPs)

  • Albumin 

  • Immunoglobulins (IVIG) 

  • Hyperimmune Globulins.  

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Modern Plasma Fractionation Technologies

  • Chromatography-Based Plasma Fractionation 

  • Viral Inactivation Systems 

  • Closed-Loop Automation Systems  

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Biopharma & Biological Products

  • Monoclonal Antibodies (MAbs) – R&D and Production 

  • Biosimilars & Recombinant Therapeutics 

  • Critical Care Injectables & Vaccines 

  • Fill-Finish Injectable Units 

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Bio-Products & Nutraceutical Ingredients

  •  Probiotics (Single and Multi-Strain) – Liquid & Powder

  • Enzymes for Digestive & Industrial Use 

  • Spores (Bacillus subtilis, coagulants, clause, etc.) – Liquid & Powder Form

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Turnkey Project Execution

  • Concept to Commissioning Services 

  • Plasma Lab Design & Execution 

  • Biopharma Plant Layouts, Cleanroom & HVAC Setup 

  • Cold Chain Logistics and Plasma Traceability Systems

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