Whitepapers

The journey from discovery laboratory to pharmacy shelf is long and arduous, particularly for highly potent APIs, which must be handled in compliance with complex regulatory requirements at each stage of the journey.

Pharmaceutical companies looking for a Contract Development and Manufacturing Organization (CDMO) to help them navigate should look for one with a combination of true expertise, capabilities and a robust assessment process giving all molecules a “potent passport” according to David O’Connell, Director of Pharmaceutical Development at PCI Pharma Services.

PPAP: Handling Hazardous Drug Activities Effectively

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PRE CLINICAL

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  • Formulation Development
  • Analytical development/characterisation

PHASE 1

PCI Phase 1
  • Formulation Development
  • Analytical Development
  • Drug in capsule/vial technology (Xcelodose)®
  • Phase I product manufacture
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  • Blinding via over-encapsulation
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PHASE 2

PCI Phase 2
  • Formulation Optimization
  • Dosage Form Process Validation
  • Analytical Testing and Stability Services
  • Phase II Product Manufacture
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  • Blinding via over-encapsulation
  • Phase II packaging and labelling
  • Storage and distribution

PHASE 3

PCI Phase 3
  • Comparator Sourcing
  • Scale Up Studies
  • Phase III Product Manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase III packaging and labelling
  • Analytical testing and stability services
  • Storage and distribution

COMMERCIAL

PCI Commercial Phase
  • Scale up for commercial supply
  • Commercial product manufacture
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  • Validation services
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  • Product release to market
  • Storage and distribution

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