Proone Labs
Preclinical partner accelerating biotech from concept to regulatory readiness.
Proone Labs provides preclinical pharmacology, drug discovery, and regulatory support services to biotech startups, traditional pharma, and in-silico companies. The team has delivered 30+ assays, 50+ cell lines, and supported 4 FDA drug approvals across multiple therapeutic areas.
Phases
Indications / Therapeutic Areas
Services
- Discovery Research
- Target Identification & Validation
- High-Throughput Screening
- Medicinal Chemistry
- Computational & In-Silico Drug Discovery
- Protein Engineering
- Preclinical In Vitro Studies
- In Vitro Pharmacology
- In Vitro ADME / DMPK
- In Vivo PK / PD Studies
- In Vivo Efficacy Models
- Preclinical In Vivo Studies
- Bioanalysis
- Ligand-Binding Bioanalysis (Large Molecule)
- Analytical Method Development & Validation
- Regulatory Affairs
- US FDA Regulatory Strategy
- Translational Research
Modalities
Technical specifications & accreditations
Accreditations
Infrastructure
About this organization
Overview
Proone Labs is a preclinical contract research organization serving the full spectrum of pharmaceutical and biotech clients—from early-stage startups and in-silico pharma companies to traditional and mid-sized pharmaceutical firms. Founded by experienced drug discovery scientists with a track record of FDA approvals and IND submissions, the company specializes in translating innovative concepts into regulatory-ready candidates.
Core Services
Preclinical Strategy & Execution
- Expert strategic guidance for biotech innovators and established pharma
- Compound characterization and workflow integration
- Pharmacokinetics and pharmacodynamics (PK/PD) studies
- Small molecule TK (toxicokinetics) support
Drug Discovery & Assay Development
- High-throughput screening and target identification
- Assay development (30+ assays delivered)
- Cell line generation and reprogramming (50+ cell lines developed)
- CRISPR editing support
- Ligand binding assays (LBAs) for protein and anti-drug antibody quantitation
- Proteomics and metabolomics services
Modality Support
- Antibodies and antibody-drug conjugates (ADCs)
- Cell reprogramming and induced pluripotent stem cell (iPSC) generation
- Small molecule development
Regulatory & Business Support
- IND-enabling studies and regulatory compliance guidance
- Proof-of-concept and platform validation
- Due diligence and IP evaluation for investors
- Market analysis and go-to-market strategy development
- Risk assessment and partnership identification
Quality & Compliance
- GLP-compliant operations with capacity for both GLP and non-GLP studies
- Stringent quality control on all data generation and reporting
- Collaborative, project-specific approach with close partner engagement
Track Record
- 30+ assays developed for targets
- 50+ cell lines developed
- 5 FDA drug approvals (including Ozanimod for multiple sclerosis and ulcerative colitis)
- 15+ IND submissions supported
- 15+ analytical methods developed
- 4 successfully funded startups supported
- 10+ industry partnerships
- 5 disease areas served
Certifications
| Authority | Identifier | Source |
|---|---|---|
| GLP | GLP-compliant | View |
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