All manufacturing services
Manufacturing
Custom Manufacturing
Manufacturing solutions developed around specific chemistry, equipment, capacity, material of construction and quality requirements.
Use case
Bespoke routes, impurity targets or equipment needs that require development, optimisation or non-standard quality alignment before routine supply.
Customer inputs
- Target structure, polymorph or impurity profile
- Available route, literature or lab data
- Scale targets and timeline
- Regulatory or customer analytical constraints
- Budget and development success criteria
Execution
- Chemistry and equipment feasibility assessment
- Literature or lab route review; gap list for scale
- Development or optimisation batches where in scope
- Analytical method alignment and specification draft
- Qualification lots at pilot or commercial scale
- Technology transfer into named commercial batch record
Responsibilities
- Customer: approves route changes, specification and registration strategy
- Development site / partner: executes scoped lab or pilot work
- Chemlyst: coordinates sites, timelines and commercial framing
- IP: ownership defined in development agreement
Deliverables
- Feasibility and risk assessment memo
- Development batch reports and updated process description
- Proposed commercial specification and manufacturing plan
- Trial COAs and recommendation for routine supply