Data-driven pharmaceutical development
Every formulation decision should increasingly be supported by analytical data.
The capability matrix
Potential capabilities include the tests below, grouped only to help you find them.
Chemical / analytical
06- Potency / assay
- Content uniformity
- Identity testing
- Impurity evaluation
- Degradation analysis
- Stability-indicating analytical methods
Performance
04- Dissolution
- Disintegration
- Hardness
- Friability
Physical properties
07- Water activity
- Moisture analysis
- Viscosity
- Rheology
- Weight variation
- Density
- Flow properties
Formulation behavior
04- Particle characteristics
- Sedimentation
- Phase separation
- Organoleptic evaluation
Analytical science integrated with development
Testing is not a gate at the end of a program. Results return to the bench and change the next iteration.
- 01 Formulate
- 02 Analyze
- 03 Learn
- 04 Adjust
Repeat — each cycle informs the next formulation
A method has a lifecycle
Potential services:
- 01 Method development
- 02 Method optimization
- 03 Method verification
- 04 Method validation where appropriate
- 05 Method transfer
Method characteristics evaluated
- Specificity
- Accuracy
- Precision
- Linearity
- Range
- Robustness
Also included
- Sample preparation development
- Stability-indicating method development
Microbiological evaluation
Potential capabilities through internal resources or qualified laboratory partners:
- Microbial enumeration
- Specified organism testing
- Sterility testing
- Bacterial endotoxin testing
- Antimicrobial effectiveness testing
- Environmental monitoring
- Surface monitoring
- Air sampling
- Bioburden
- Growth promotion
- Microbial method suitability
Beyond-use dating supported by science
Program design
03- BUD strategy
- Stability protocol development
- Stability-indicating assay strategy
Study types
03- Real-time stability
- Accelerated stability studies where appropriate
- Intermediate testing
Attributes evaluated
05- Physical stability
- Chemical stability
- Water activity
- Microbiological considerations
- Preservative effectiveness considerations
Storage & handling
05- Controlled room temperature storage
- Refrigerated storage
- Freeze/thaw evaluation
- Light sensitivity
- Shipping excursion evaluation
Packaging
02- Packaging compatibility
- Container-closure evaluation
Each condition below is written into the approved protocol for the individual product. Conditions, timepoints, durations and acceptance criteria are set there.
- Real-time storage
- Storage condition, duration, timepoints
- Accelerated storage
- Storage condition, duration, timepoints
- Temperature
- Set point and tolerance
- Light exposure
- Source, intensity, duration
- Freeze/thaw
- Cycle count and hold times
- Packaging
- Container-closure system tested
- Shipping excursion
- Excursion profile and duration
Assigned BUDs must remain supported by applicable law, standards, formulation characteristics, available stability data, packaging, storage conditions, and the specific regulatory framework governing the preparation.
