Molecular Technologies Laboratories LLC dba InfinixBio
InfinixBio is a full-service, cost-effective CRO that partners with clients to expand capabilities and meet key milestones in biotech and pharmaceutical development. With a team comprising expert scientists and PhDs, operating in BSL Level II labs, InfinixBio helps clients accelerate their technology to market through a proprietary Rapid Innovate Model™, supporting drug development, diagnostics, biologics, and innovative assay development with a focus on regulatory compliance, innovation, and strategic growth.
Industries
Nr. of Employees
small (1-50)
Molecular Technologies Laboratories LLC dba InfinixBio
Services
Early drug development services
Assay development, protein expression and characterization, genetic engineering, and cell line development to support lead optimization and preclinical readiness.
Preclinical GLP and non‑GLP CRO services
Preclinical study design, animal model selection, GLP bioanalysis, PK/TK analysis, toxicology support, immunogenicity testing and biomarker testing services with regulatory‑ready reporting.
Clinical development and GLP bioanalytical services
GLP-compliant assay development and validation, clinical PK analysis, toxicology support, immunogenicity/NAb testing, and biomarker analysis to support clinical trials and regulatory submissions.
BioProduction and process development
Upstream and downstream bioprocess development, host cell engineering support, process optimization, scale‑up planning and coordination with GMP manufacturers for tech transfer to clinical/commercial production.
Laboratory diagnostic development (510(k) and LDT support)
Analytical development and validation of diagnostic assays, preparation of design history and testing to enable 510(k) or LDT submissions and handoff to clinical/CLIA labs.
Assay method development and FDA/ICH validation support
Method development using QbD and DoE, sequential validation strategies, system suitability testing, statistical analysis and preparation for regulatory inspections and submissions.
Early drug development services
Assay development, protein expression and characterization, genetic engineering, and cell line development to support lead optimization and preclinical readiness.
Preclinical GLP and non‑GLP CRO services
Preclinical study design, animal model selection, GLP bioanalysis, PK/TK analysis, toxicology support, immunogenicity testing and biomarker testing services with regulatory‑ready reporting.
Clinical development and GLP bioanalytical services
GLP-compliant assay development and validation, clinical PK analysis, toxicology support, immunogenicity/NAb testing, and biomarker analysis to support clinical trials and regulatory submissions.
BioProduction and process development
Upstream and downstream bioprocess development, host cell engineering support, process optimization, scale‑up planning and coordination with GMP manufacturers for tech transfer to clinical/commercial production.
Laboratory diagnostic development (510(k) and LDT support)
Analytical development and validation of diagnostic assays, preparation of design history and testing to enable 510(k) or LDT submissions and handoff to clinical/CLIA labs.
Assay method development and FDA/ICH validation support
Method development using QbD and DoE, sequential validation strategies, system suitability testing, statistical analysis and preparation for regulatory inspections and submissions.
Expertise Areas
- Assay development and analytical validation
- GLP bioanalysis and PK/TK support
- Immunogenicity assessment and ADA/NAb testing
- Diagnostic assay development and regulatory submissions (510(k), LDT)
Key Technologies
- LC-MS/MS
- Ligand‑binding assays (ELISA/LBA)
- Multiplex immunoassays
- qPCR