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Biological Derivatives

At PCI we recognise that biologically derived therapeutic products are the new frontier, heralding revolutionary treatments of a number of diseases and injuries.

These therapies traditionally have widely varying temperature requirements and maintaining a robust Cold Chain process is critical to the integrity of the products.

PCI provides market leading services for products requiring specialist Cold Chain management.

Through the acquisition of Biotec Services International, PCI provides pharmaceutical service solutions for a range of therapies including gene therapies, somatic cell therapies (stem cells) and tissue engineered products also known as Advanced Therapeutic Medicinal Products (ATMPs).

With over 10 years of experience with such products, PCI will assist you with innovative solutions to overcome the specific challenges associated with the storage, labeling and delivery

at cryogenic temperatures to -196oC. This experience combined with our proven track record of working with dry ice and dry nitrogen shipping systems ensures that we are able to offer a full ATMP service. PCI is committed to remaining abreast of the latest advances in shipping technology.

Our Technical Support Team is dedicated to testing and validating the newest technologies ensuring that we utilize the most economic yet most effective and reliable shipping methods supported by our exceptional track record in temperature controlled shipments.

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Explore the PCI Process Phase by Phase

PRE-CLINICAL
PHASE I
PHASE II
PHASE III
COMMERCIAL

Swipe to explore the PCI Process

PRE CLINICAL

pre-clinical-icon
  • Formulation Development
  • Analytical development/characterisation

PHASE 1

PCI Phase 1
  • Formulation Development
  • Analytical Development
  • Drug in capsule/vial technology (Xcelodose)®
  • Phase I product manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase I packaging and labelling
  • Storage and distribution

PHASE 2

PCI Phase 2
  • Formulation Optimization
  • Dosage Form Process Validation
  • Analytical Testing and Stability Services
  • Phase II Product Manufacture
  • Tablets/Capsules
  • 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
  • Commercial packaging and labelling
  • Validation services
  • Analytical testing and stability services
  • Product release to market
  • Storage and distribution

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