Process development and scale-up
Route scouting, reaction optimization, crystallization design, and tech transfer packages that turn a workable lab sequence into a reproducible plant-ready process—without rediscovering impurities at every scale tier.
QbD
DOE-friendly workflows
Tech pack
CMO-ready transfer
PAT
inline IR / HPLC where fit
Impurity
purge & fate mapping
Development approach
Process development starts from the question regulators and manufacturing will ask: what controls identity, potency-relevant purity, and reproducibility at commercial scale? We document critical process parameters (CPPs), proposed design space, and impurity carryover rationale—not only optimized yields.
Scale-up is staged: lab (gram), pilot (sub-kilogram to multi-kilogram), and demonstration batches aligned to your validation strategy. Hazardous or highly exothermic steps are flagged early for flow or semi-batch alternatives.
Typical development phases
Timelines compress or expand with route complexity and GMP depth.
Route confirmation
Manufacturing
Repeatability at 10–100 g; solvent/heavy metal survey
Analytics
Impurity ID, RRt library, genotoxic alert review
Stability
Forced degradation pointers for method robustness
Regulatory
Starting material justification draft
Optimization
Manufacturing
DOE on yield-critical steps; workup simplification
Analytics
Validation prep for assay and related substances
Stability
Salt/polymorph screen if applicable
Regulatory
Control strategy outline
Pilot & tech transfer
Manufacturing
Equipment-matched batches; cleaning validation inputs
Analytics
Inter-lab method transfer support
Stability
Primary stability batches initiated
Regulatory
Section 3.2.S draft support (client-led filing)
Common scale-up risk signals
| Observation at lab scale | Likely cause | Mitigation |
|---|---|---|
| New HPLC peak >0.5% at 10× scale | Over-reaction or thermal hold time | Temperature control, addition rate, or flow conversion |
| Filtration longer each scale | Particle size distribution shift | Seed crystal protocol, antisolvent addition rate |
| Color body persists | Purge failure of downstream impurity | Re-sling intermediate isolation or rework strategy |
| Moisture drift in API | Open handling of hygroscopic solid | Controlled humidity suite, continuous drying |
Figures are indicative industry-typical values. Lot- and project-specific data appear on the quotation and certificate of analysis.
Tech transfer package
- Master batch record and equipment list with CPP ranges
- Analytical methods (assay, impurities, residuals, KF)
- Impurity fate and purge table
- Bill of materials with qualified alternate suppliers where allowed
- Safety summary for exotherm, dust, and potency classification
When to pair with flow chemistry
Hazard assessment
Azides, nitrations, and ultra-low temperature organometallic steps are candidates for continuous processing.
Residence time mapping
Lab flow reactors establish kinetics; batch CPPs translate to flow equivalents.
Integrated API path
Hybrid routes—flow for the hazardous step, batch for crystallization—are often the pragmatic commercial design.
Frequently asked questions
We support PPQ campaigns and validation documentation under client quality systems. Scope is defined in the quality agreement.
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View detailsReady to specify this for your program?
Share sequence, scale and documentation needs. We reply with indicative specs and a project-specific quotation.