Traceable decisions
The rationale for key technical choices is documented, including why specific platforms, conditions, and process strategies were selected over alternatives.
Quality and development rigor
Quality at ArtProtein starts at the design and documentation stage. Non-GMP development work is planned and recorded so that future regulatory and tech-transfer activities are supported, not hindered.
Core principles
Regulatory awareness
CMC and USDA 9CFR expectations are considered throughout planning and execution, so that development work naturally feeds into regulatory submissions and partner discussions.
Fit-for-purpose documentation
Reports, protocols, and summaries are prepared at a level of detail that is practical for project teams and robust enough for later regulatory and GMP use.
Deliverables
Development strategies & study outlines
Structured plans with clear objectives, success criteria, and links between transient and stable expression studies, upstream optimization, and purification work.
Risk assessments & mitigations
Identification of key technical and CMC risks, along with practical mitigation options and contingency paths that can be implemented by lean development teams.
Regulatory-ready summaries
Technical reports and summaries suitable for CMC modules, USDA 9CFR proposals and final reports, and internal governance, prepared in a way that is easy to integrate across documents.
Connecting small scale to tech transfer
Data integrity & structure
Data from small-scale and transient expression runs is captured and organized to show how it supports decisions on scale-up, clone selection, and process control.
Consistency across documents
The same core story and data are reflected consistently across development reports, CMC sections, and USDA 9CFR documentation to avoid gaps and contradictions.
Preparation for GMP partners
Documentation and process descriptions are structured so that GMP manufacturers and QA/Regulatory teams can quickly understand the development history and rationale behind your process.