Product Development Capabilities
Development Services
- evaluate customer-supplied or requested raw materials for suitability
- develop stable fill material formulations
- develop gelatin formulations
- perform fill material gelatin interaction studies
- develop colour formulations and provide colour matching
- evaluate printing requirements
cGMP Manufacturing Services
- can provide the use of a cGMP isolation suite manufacturing area for development of drug products up to clinical batch stage (includes segregated dispensing, cleaning, compounding, encapsulation, inspection, polishing, printing and packaging areas)
- manufacture feasibility batches
- conduct drying profiles
- evaluate capsule dynamics and equilibrium (applies to water miscible/soluble and hygroscopic systems)
- manufacture stability batches for customer’s stability program
- manufacture cGMP clinical batches for bio-studies
- using full-scale facilities, determine production parameters to manufacture initial scale-up batch
- manufacture and conduct process validation batches using the first three commercial lots
Analytical Services
- perform required testing on manufactured capsules to support/verify product development objectives
- provide analytical method development service
- provide analytical method validation service
- provide analytical release testing on feasibility, stability and clinical batches