Moving beyond exploratory radiolabeling
You have an initial radiolabeling approach and need to develop a more consistent process for further work.
CDMO · Process & Analytical Development
Process & Analytical Development
HUAHE integrates process and analytical development to build the process understanding needed for scale-up, process control and technology transfer. Under the Project Master Plan, product quality objectives guide studies of starting materials, radiolabeling, purification, formulation, analytical methods and stability, accounting for radioactive decay, radiolysis and narrow operating windows.
Discuss process & analytical development
Your starting point
Where this service fits
Investigating process and stability questions
You need to evaluate how starting materials, purification, formulation, or radiolysis may affect product quality.
Preparing for scale-up or technology transfer
You need process understanding and analytical documentation to support scale-up to the intended manufacturing scale or transfer to a proposed receiving site.
Scope of work
Radiopharmaceutical process and analytical studies
Integrated delivery
HUAHE plans and coordinates delivery by specialist organizations, with responsibilities, stage deliverables and acceptance criteria defined in the Project Master Plan.
Starting materials and radiolabeling
Evaluate radionuclide quality, material attributes, reactant ratios, specific activity and the radiolabeling operating window against product quality objectives.
Purification and formulation
Evaluate purification media and yield, radiolysis, and formulation and container-closure compatibility within the available processing window.
Analytical methods and stability
Develop or refine methods for identity, chemical purity, radiochemical purity, radionuclidic purity, activity concentration and stability, as appropriate to the project stage.
Process characterization
Start with the quality target product profile (QTPP) and critical quality attributes (CQAs). Use development data and risk assessment to identify potential critical material attributes (CMAs), critical process parameters (CPPs), working ranges and failure modes, supporting a stage-appropriate control strategy, process monitoring and equipment adaptation.
Project outcomes
What you receive
You receive a stage-appropriate technical package supporting scale-up, site adaptation and technology transfer, with proposed operating ranges, control measures and documented risks.
- Process development plans and technical reports
- Proposed process flows and parameter ranges
- Analytical development and stability documentation
- Risk and control recommendations and documentation for technology transfer
Analytical development alone does not establish validated analytical procedures or release specifications. Analytical method validation or verification, routine quality-control testing, batch-release testing, and manufacturing under Good Manufacturing Practice (GMP) must be explicitly scoped for the intended use and performed at appropriately qualified sites; batch-release decisions remain with the authorized party.
Discuss your development priorities
Share the current process stage, the question you need to address, and whether you are preparing for further development, scale-up, or technology transfer.
Discuss process & analytical developmentConnected expertise
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