R&D / Formulation
Pharmaceutical formulation development support
Structuring an immediate-release tablet development so trial data leads to a scalable, documented formulation.
Illustrative use caseIllustrative use case
Pharmaceutical process optimisation
Reducing yield loss and in-process rejections in an oral solid dosage process.
Challenge
Yield varied between batches and root causes were debated rather than measured.
Requirement
Identify the process variables behind yield loss and set improved controls.
Approach
Collect historical batch data, run statistical analysis, then confirm suspected factors with a limited study.
Process & execution
- 1Data collection
- 2Statistical analysis
- 3Hypotheses
- 4Confirmation study
- 5Control update
- 6Change control
Technology / process
- Statistical process control
- Multivariate analysis
- Process capability (Cpk)
Documentation
- Data analysis report
- Study protocol/report
- Change control record
Verification
Post-change batches monitored against capability targets.
Outcome / expected benefit
Expected benefit: stable yields and parameters grounded in data.
This is an illustrative use case describing a typical project structure. It does not describe a specific client, product or completed engagement.
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Manufacturing / CMO
External manufacturing partner identification
Finding and evaluating a qualified manufacturer for an oral solid product for a regulated market.
Illustrative use case
CMO / Manufacturing
CMO technology transfer support
Transferring a granulated tablet process from a development site to a contract manufacturer.
Illustrative use case