Bespoke Pharmaceutical is purpose built to support injectable drug programs at the
stages where precision, flexibility, and technical clarity matter most.
We operate as a non GMP sterile injectable manufacturing partner focused on development,
engineering, and early clinical support.
By working upstream, we enable smoother scale up, fewer surprises, and stronger outcomes
when programs transition to qualified manufacturing partners.
Capabilities
Capabilities at Bespoke Pharmaceutical
Non GMP
Sterile Focus
Upstream
Risk Reduction
Transfer Ready
Transfer Aligned
Capability Focus
Non GMP Sterile Injectable Manufacturing
Bespoke specializes in non GMP sterile injectable manufacturing designed to closely
simulate GMP conditions without the constraints of commercial release.
Our facility supports sterile fill finish activities in controlled aseptic environments for development and engineering purposes. This allows sponsors to test real world manufacturing scenarios early in their program.
By identifying challenges early, partners can enter GMP manufacturing with greater confidence and clarity.
Our facility supports sterile fill finish activities in controlled aseptic environments for development and engineering purposes. This allows sponsors to test real world manufacturing scenarios early in their program.
By identifying challenges early, partners can enter GMP manufacturing with greater confidence and clarity.
Process feasibility and risk reduction
Early identification of technical and operational challenges
Engineering and demonstration runs
Hands on evaluation of real manufacturing behavior
Early clinical material preparation
Controlled aseptic fill finish for development programs
Fill finish strategy development
Decisions validated before GMP execution
Formulation Capability
Formulation Development and Feasibility
Strong injectable programs begin with a formulation that is compatible with both the
drug substance and the intended container system.
Bespoke supports formulation development and feasibility activities including excipient compatibility assessments, stability driven optimization, and container closure compatibility studies.
These activities help define a formulation that is not only scientifically sound but also manufacturable at scale.
Bespoke supports formulation development and feasibility activities including excipient compatibility assessments, stability driven optimization, and container closure compatibility studies.
These activities help define a formulation that is not only scientifically sound but also manufacturable at scale.
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Excipient compatibility assessments
Evaluation of excipient interactions to support stability and performance.
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Stability driven formulation optimization
Data guided formulation refinement based on real stability behavior.
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Container closure compatibility studies
Assessment of formulation and container interactions under realistic conditions.
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Fill volume and concentration evaluation
Determination of parameters that support scalability and fill finish execution.
Aseptic Engineering
Aseptic Process Design and Engineering
Bespoke operates as a non GMP aseptic engineering and development partner, supporting
injectable programs during the stages where process understanding and risk reduction
are critical.
Through hands on engineering runs and controlled aseptic simulations, sponsors gain direct insight into how their process behaves under realistic manufacturing conditions, without commercial GMP release.
Through hands on engineering runs and controlled aseptic simulations, sponsors gain direct insight into how their process behaves under realistic manufacturing conditions, without commercial GMP release.
Equipment selection and configuration
Engineering driven decisions aligned with process demands and future transfer needs.
Aseptic workflow definition
Practical workflows designed around operator behavior and development scale realities.
Fill finish strategy
Development focused strategies for vials, syringes, and cartridges.
Simulation of GMP aligned conditions
Exposure to GMP expectations through non GMP engineering and process simulation.
By engineering aseptic processes in a non GMP environment, Bespoke helps sponsors
de risk development programs and prepare cleaner, more informed transitions into
downstream GMP manufacturing.
Execution & Engineering
Sterile Fill Finish Engineering Runs
Bespoke performs sterile fill finish engineering runs exclusively in a
non-commercial, non-release environment focused on process understanding.
These activities are designed to expose real process behavior, identify operational and quality risks, and generate data that supports confident program advancement.
These activities are designed to expose real process behavior, identify operational and quality risks, and generate data that supports confident program advancement.
Filling accuracy and consistency
Measurement of fill performance across containers and operating conditions
during controlled engineering runs.
Particulate and cosmetic risk identification
Early identification of visible and subvisible quality risks before
external manufacturing execution.
Container performance during filling
Evaluation of vial, syringe, and cartridge behavior during process simulation.
Process parameter optimization
Refinement of process settings and controls prior to technology transfer
into commercial manufacturing environments.
Bespoke operates strictly as a non-GMP engineering and development facility.
No commercial manufacturing or regulatory release activities are performed.
Insights generated support cleaner, lower-risk transitions into external
manufacturing organizations.
Inspection & Evaluation
Visual Inspection and Process Evaluation
Inspection is where injectable programs are evaluated, not assumed.
Bespoke applies structured visual inspection and process evaluation
within a non-commercial, non-release environment to expose risks,
assess real outcomes, and define inspection approaches that support
later-stage manufacturing readiness.
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Particulate and defect detection
Early identification of visible and subvisible defects that impact
product quality and inspection outcomes.
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Fill quality and appearance assessment
Evaluation of cosmetic attributes, fill consistency, and container
presentation under realistic operating conditions.
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Inspection risk identification
Early insight into inspection-related risks before external
manufacturing execution begins.
Packaging Capability
Development Packaging and Kitting
Bespoke supports development stage packaging activities that prepare injectable
products for clinical and technical use. These services are provided in a strictly
non-commercial, non-release environment as part of Bespoke’s non-GMP operations.
Packaging is designed to maintain program continuity while preserving flexibility
for evolving requirements.
Labeling and secondary packaging
Application of labels and secondary components appropriate for development
and early clinical programs.
Kitting for development and clinical programs
Assembly of complete kits to support clinical workflows and technical studies.
Material preparation
Preparation of packaged materials for transport, storage, or downstream processing.
Program continuity support
Packaging approaches that adapt as program requirements evolve through development
and external manufacturing planning.
GMP Readiness
Documentation and GMP Tech Transfer Support
By the time a program leaves Bespoke, it is no longer theoretical.
Processes have been exercised, decisions documented, and risks
surfaced early so GMP execution begins with clarity and confidence.
- Clear documentation of processes and parameters
- Engineering run data packages for GMP execution
- Risk identification and mitigation summaries
- Direct collaboration with downstream GMP CDMOs
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