Pharmaceutical process development is an exacting science. Mikart’s meticulous, iterative approach involves repeated, small-scale batches that allow us to incrementally improve your formulation quickly and efficiently until it’s ideal for full-scale commercial production.
What’s different about our approach?
Once the appropriate excipients and the basic process are determined for your product, a larger-scale batch is manufactured in our GMP facilities. This will be used to evaluate operational parameters, assuring the defined QTPP, CQA, and physical and chemical specifications are met and that the ideal dosage form is produced.
Our cross-functional team at Mikart reviews your product’s processes and procedures with you, highlighting potential quality and cost-enhancement opportunities. Additional batches demonstrate the benefit of identified improvements until you are satisfied. Meticulous data tracking facilitates superior process validation later in development.
Capabilities
| Low humidity environments |
| Quality by design (QBD) principles |
| Site transfers |
| Thermal cycling studies |