Formulation & Process Development
Getting a botanical extract or standardized alkaloid ingredient from a bench result to a reproducible, specification-meeting material is a process problem as much as a chemistry problem. We design, characterize, and scale processes with the controls, documentation, and data needed to run them the same way every time.
Formulation development
Material characterization. Solubility, hygroscopicity, thermal behavior, particle properties, and compatibility screening so formulation decisions rest on measured properties rather than assumptions.
Standardization. Blending, carrier selection, and normalization strategies to deliver a consistent target content of the active or marker compound across lots.
Stability by design. Excipient compatibility, packaging evaluation, and accelerated stability to identify degradation pathways early and design them out.
Dosage-form support. Pre-formulation and formulation development for powders, granulations, liquids, and encapsulated formats, produced to a client-defined specification.
Process development
Process mapping. Every unit operation, from starting material through isolation, purification, drying, and milling, is documented with its inputs, outputs, and control points.
Critical process parameters. Designed experiments identify which parameters actually drive yield, purity, and impurity profile, and set proven acceptable ranges for each.
Scale-up. Bench to pilot to production transfer with engineering assessments, equipment qualification support, and confirmatory batches analyzed against the full release specification.
Process documentation. Batch records, process flow diagrams, in-process control plans, and cleaning and changeover procedures written for operators, not just scientists.
Deliverables
- Formulation and process development reports
- Master batch records and in-process control plans
- Specifications for raw materials, intermediates, and finished materials
- Stability protocols and data summaries
- Technology-transfer packages for internal or third-party manufacturing
Working with us
Projects are structured in stages with defined deliverables and decision points, so you can stop, redirect, or scale at each gate. Every stage is supported by our in-house analytical laboratory.