Drug Discovery & Process Development

ACCELERATING DRUG DEVELOPMENT THROUGH INTEGRATED DISCOVERY AND PROCESS CHEMISTRY

Advancing drug candidates through innovative chemistry, efficient process development, and scalable manufacturing pathways.

Integrated Discovery & Process Chemistry

SmaBio Labs partners with innovators to accelerate drug development through integrated discovery and process chemistry expertise. From lead optimization and route design to process development and scale-up, we deliver robust, scalable chemistry solutions that help transform promising molecules into development-ready drug substances.

#drugdiscovery

Early-Stage Scientific Support

Accelerating development readiness through screening, characterization, and lead optimization.

Screening & Assay Development

• Target-based and phenotypic screening assay design

• Assay development, optimization, and validation

• Primary and secondary screening to ensure data robustness and reproducibility

Building a Strong Foundation

for IND-Enabling Studies

Anchor 1

mg-g Scale API

mg–g Scale API and Intermediate Production

Rapid synthesis to support discovery and early development
Flexible milligram-to-gram scale manufacturing
Early feasibility and route evaluation
Optimization for yield, purity, reproducibility, and scalability

Small-Scale Batches

Evaluation of synthetic routes and process parameters
Identification of scale-up and impurity risks
Support for analytical method development and impurity profiling
Initial stability assessments
Phase-appropriate methods to measure critical quality attributes (CQAs)
Methods optimized for specificity, sensitivity, accuracy, and robustness
Enables release testing, impurity identification, and regulatory submissions

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Scalable, Phase-Appropriate

cGMP Capabilities

Anchor 2

kg-Scale API Manufacturing

cGMP-compliant API production to support Clinical Trial Material (CTM) manufacturing for Phase I - III
High purity and batch-to-batch consistency
Bridging laboratory processes to clinical supply
Seamless technology transfer and scale-up risk mitigation
cGMP controls aligned with global regulatory expectations
Tailored analytical validation strategies by clinical phase
Early-phase focus on specificity, accuracy, and reproducibility
Full ICH-compliant validation for late-stage programs
Shelf-life determination and storage condition verification