5. IND-Enabling Studies Support

Advance candidates into the clinic with confidence and comprehensive data packages.

Key Capabilities

Biologics: Functional characterization, PK/PD studies via partners, and batch-scale protein supply

Protein Science: GMP-adjacent production of tool and reagent proteins for IND-enabling assays

Strategic Consulting: IND planning, regulatory guidance, and market-positioning strategy

Data Science: Clean, auditable, traceable datasets supporting regulatory submissions

Structural Biology: Confirmation of target engagement and structural rationale for candidate selection

Value to Your Program

Streamlined transition from discovery to development

Structured data that meets regulatory and audit requirements

Flexible and scalable assay support for preclinical decision-making

Strategic guidance to support partnering, funding, and clinical milestones

Validation Metrics

Guided 12+ biologics into IND with comprehensive data support

Produced GMP-grade proteins with consistent QC metrics across batches

Supported clients reducing preclinical readiness timelines by up to 35%

Enabled successful IND filings and Series A/B raises via data-driven strategic positioning