CDMO / R&D
CDMO product development coordination
Coordinating formulation, analytical and scale-up work across a CDMO and a separate testing laboratory.
Illustrative use caseIllustrative use case
Pharmaceutical formulation development support
Structuring an immediate-release tablet development so trial data leads to a scalable, documented formulation.
Challenge
Early trial batches showed variable dissolution, and development records were spread across notebooks and spreadsheets.
Requirement
A robust formulation with a defined control strategy and a development report suitable for transfer.
Approach
Define critical quality attributes, run a risk assessment on formulation and process variables, then use a designed experiment on the high-risk factors.
Process & execution
- 1Target product profile
- 2Risk assessment
- 3DoE trials
- 4Dissolution comparison
- 5Optimised formula
- 6Development report
Technology / process
- Design of Experiments
- Comparative dissolution (f2)
- ICH Q8 / Q9
Documentation
- Development plan
- Risk assessment
- DoE report
- Pharmaceutical development report
Verification
Confirmatory batches at the optimised settings, tested against the agreed dissolution acceptance criteria.
Outcome / expected benefit
Expected benefit: a formulation with understood sensitivities and a report the manufacturing partner can use directly.
This is an illustrative use case describing a typical project structure. It does not describe a specific client, product or completed engagement.
More use cases
Manufacturing / R&D
Pharmaceutical process optimisation
Reducing yield loss and in-process rejections in an oral solid dosage process.
Illustrative use case
Manufacturing / CMO
External manufacturing partner identification
Finding and evaluating a qualified manufacturer for an oral solid product for a regulated market.
Illustrative use case