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Pharmaceutical Development Including Highly Potent Molecules

Following the acquisition of Penn Pharma, our comprehensive pharmaceutical development service offering includes early stage formulation and analytical development, drug in capsule/vial using Xcelodose® technology, scale-up and stability testing process validation, technology transfer and all associated analytical support services.

Formulation Development

PCI provide CMC Consultancy services to generate the optimum development strategy for your product. By involving our experts early in the strategic development of your new product, we can assist in optimizing the process, ensure that regulatory hurdles are minimized and that the most efficient routes to clinic are delivered. We are able to offer formulation development services for a variety of dosage forms including:

  • Tablets, capsules and powders
  • Gels and creams
  • Liquids, solutions, suspensions and emulsions
  • Suppositories and pessaries
  • Granules for reconstitution
  • Liquids for sterilization
  • Drug in capsule/vial

In addition to our standard operations, PCI has created a center of excellence for the contained manufacturing of highly potent molecules. This new facility for solid oral dose formulations is able to safely process potent products with an OEL of 0.01µg/m3 (8-hour time weighted average).

Contained Pharmaceutical Development for Highly Potent Molecules

PCI has a long and successful track record in the development and manufacture of products requiring containment resources. Our facilities and capability for handling potent products enables the safe development, clinical and commercial supply of products with an OEL down to 0.01 μg/m3.

Investment in leading-edge engineered technology places us at the forefront of the industry and enables the provision of a fully comprehensive service for solid dose potent dosage forms.

The development facility created by Penn Pharma for tablets and capsules utilizes processing technologies including high shear granulation and fluid bed drying plus roller compaction that are common with our larger scale production unit.

Equipped to meet the needs of development and clinical batch requirements, our development facility is scaled to produce up to 10kg batches of capsules or film coated tablets.

 

 

 

Contained Operations Overview

  • Capability to process multiple compounds
  • Development scale (1kg) to commercial scale (120kg) batch sizes
  • Segregated people and material flows
  • Secure access and client viewing gallery
  • Automated cleaning procedures
  • Contained engineering solutions eliminating the need for PPE
  • HVAC system with single pass air
  • Temperature and humidity controlled processing areas
  • Small and large-scale packaging options
  • Meeting global regulatory standards including the MHRA, the FDA, ANVISA, Turkish Ministry of Health and Japan
  • Design-for-manufacture delivering true speed-to-market

PCI are able to develop modern and novel dosage forms and delivery systems in-line with client need. We offer specialist knowledge for handling moisture sensitive molecules and the development of modified release formulations. Our expirienced team of senior scientists utilize enabling technologies to offer problem solving services for the most challenging of applications including solubility enhancement.

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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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