Process Development & Scale-Up
Turning bench-scale discoveries into robust, scalable manufacturing processes
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Great chemistry in a flask doesn’t always translate to a 2,000-liter reactor. We bridge the gap between medicinal chemistry and commercial manufacturing by designing synthetic routes that are safe, efficient, and cost-effective.
Whether you need to optimize a difficult step for a Phase 1 batch or redesign a route for commercial launch, we provide the deep technical expertise to ensure your process delivers—on time and on spec.
Our Technical Capabilities
Our Technical Capabilities
Route Scouting & Design
Route Scouting & Design
We evaluate existing synthetic routes and design "fit-for-purpose" alternatives to support your current stage of development.
Route scouting for scalability and cost-reduction (COGS).
Identification of non-infringing routes for IP strategy.
Selection of regulatory starting materials (RSM).
Optimization & Engineering
Optimization & Engineering
We move beyond "trial and error" by using data-driven methodologies to define the design space.
DoE (Design of Experiments): rigorous statistical optimization of critical parameters.
QbD (Quality by Design): Establishing critical process parameters (CPPs) and critical quality attributes (CQAs).
Process safety assessments and hazard evaluation.
Scale-Up & Tech Transfer
Scale-Up & Tech Transfer
We manage the physical transition from the lab to the plant, ensuring the process holds up under GMP conditions.
Scale-up from grams to 100+ kg.
Fate and purge studies for impurities.
Preparation of Master Batch Records and Tech Transfer Packages.
The "HIL" Difference
The "HIL" Difference
Don’t Just "Run" the Process. Own It.
Don’t Just "Run" the Process. Own It.
Many startups rely entirely on CDMOs for process development. The risk? You end up with a process that works once but fails when you move to a larger facility.
At HIL CMC Consulting, we act as your technical advocate. We scrutinize the data, challenge the CDMO’s assumptions, and ensure that the process being developed is an asset you own—robust, transferable, and ready for regulatory scrutiny.
Typical Outcomes
Typical Outcomes
For Earlier Stage
For Earlier Stage
For Earlier Stage
Rapid delivery of GLP/GMP material.
Removal of dangerous reagents/conditions.
"Fit-for-purpose" route selection.
For Later Stage
For Later Stage
Optimized Cost of Goods (COGS).
Validated process control strategies.
robust impurity control (Genotoxins/Elementals).
Explore Other Services
Explore Other Services
Looking for more? Explore our other core capabilities:
Looking for more? Explore our other core capabilities:
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