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ACCELERATING DRUG DEVELOPMENT THROUGH INTEGRATED DISCOVERY AND PROCESS CHEMISTRY

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

Executive Overview

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.

Drug Discovery

Drug Dsicovery

Early-Stage Scientific Support to Accelerate Development Readiness

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

Hit-to-Lead Characterization

Anchor 2

  • Structure–activity relationship (SAR) exploration

  • Potency and selectivity evaluation

  • Physicochemical property assessment

  • Early ADME and developability risk assessment

Lead Optimization

lead

  • Iterative medicinal chemistry and biology integration

  • Optimization of potency, selectivity, and pharmacokinetics

  • Mitigation of safety and developability risks

  • Nomination of development-ready lead candidates

Process Development

Process Development

Building a Strong Foundation for IND-Enabling Studies

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

Process Scaleup

Process Scaleup

Scalable, Phase-Appropriate cGMP Capabilities

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

DMF Filing & Regulatory Support

DMF Filing

End-to-End Drug Master File Support for Global Regulatory Submissions

  • Authoring, and filing of US FDA Type II and Type III DMFs

  • Complete CMC documentation covering manufacturing process, controls, specifications, and batch data

  • QbD-aligned process descriptions, including CQAs, CPPs, and control strategies

  • Impurity profiling, qualification, and justification per ICH Q3A/Q3B

  • Analytical method summaries and phase-appropriate validation support

  • Stability study design, data generation, and reporting per ICH Q1

  • Cross-reference support for IND, ANDA, NDA, and 505(b)(2) submissions

  • Regulatory correspondence support, including FDA information requests and deficiencies

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