How Bespoke Builds
Injectable Processes
Bespoke Pharmaceutical operates a non-GMP sterile injectable manufacturing environment focused on process development, engineering runs, and early clinical support, enabling smooth, risk-reduced GMP transfer.
Non-GMP Manufacturing Capabilities
Our facility is purpose-built to simulate GMP-like aseptic operations without GMP release constraints, accelerating development while maintaining technical rigor.
Formulation Development
Compatibility studies and formulation optimization.
Process Engineering
Equipment setup and aseptic simulation.
Sterile Fill-Finish
Engineering runs for vials, syringes, cartridges.
Inspection
Visual and automated evaluation of process output.
Packaging
Labeling and kitting for development programs.
GMP Transfer
Clean data handoff to GMP CDMOs.
Formulation Development
Compatibility studies and formulation optimization.
Process Engineering
Equipment setup and aseptic simulation.
Sterile Fill-Finish
Engineering runs for vials, syringes, cartridges.
Inspection
Visual and automated evaluation of process output.
Packaging
Labeling and kitting for development programs.
GMP Transfer
Clean data handoff to GMP CDMOs.
Important Non-GMP Clarification
- Bespoke is a NON-GMP manufacturing facility.
- No GMP drug product release.
- Material intended for development, engineering, and clinical support only.
- Commercial GMP manufacturing must occur at a qualified CDMO.
Where Bespoke Fits in Your Journey
Bespoke Pharmaceutical operates in the critical space before GMP, where injectable processes are defined, stress-tested, and prepared for successful scale-up.
Early Concept
Formulation feasibility, container compatibility, and early risk identification.
Process Design
Equipment selection, fill strategy, and aseptic workflow definition.
Engineering Runs
Non-GMP sterile fill-finish simulations to validate process performance.
GMP Transfer
Clean documentation and handoff to qualified GMP CDMOs.
Build Smarter.
Fail Earlier.
Scale Faster.
Bespoke exists to absorb uncertainty before it becomes expensive. Our non-GMP injectable manufacturing platform allows partners to uncover risks, optimize processes, and enter GMP with confidence, not assumptions.
- ✔ Reduce GMP trial-and-error
- ✔ Identify fill and container risks early
- ✔ Accelerate tech transfer timelines
- ✔ Preserve capital during development
Ready to De-Risk Your Injectable Program?
Talk to Bespoke about how we can support your development, engineering, or clinical manufacturing needs.
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