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)
InfinixBio
Products
Assay Development
Comprehensive CRO services for developing, qualifying, and validating diagnostic and research assays to support regulatory approval and sample analysis.
Assay Development and Sample Testing
Collaborative assay development and sample testing services to advance through the regulatory approval process.
Custom Genetic Engineering Services
Genetic engineering technology and molecular biology services including chromosomal gene modification of E. coli and mammalian cell lines, and design of multifunctional engineered proteins.
Comprehensive Genetic Engineering Services
State-of-the-art genetic engineering services designed to empower life science firms throughout the drug development lifecycle, including CRISPR-Cas9 technology, gene cloning, and cell line development.
Bio Production Client Solutions
Tailored bio production and contract research services designed to facilitate the development and manufacturing of biological products, offering support across all stages of research and development.
Organ-on-a-Chip Services
Comprehensive microfluidic organ-on-a-chip CRO services designed to mimic human physiological responses for preclinical drug development, toxicity testing, and disease modeling.
Assay Development
Comprehensive CRO services for developing, qualifying, and validating diagnostic and research assays to support regulatory approval and sample analysis.
Assay Development and Sample Testing
Collaborative assay development and sample testing services to advance through the regulatory approval process.
Custom Genetic Engineering Services
Genetic engineering technology and molecular biology services including chromosomal gene modification of E. coli and mammalian cell lines, and design of multifunctional engineered proteins.
Comprehensive Genetic Engineering Services
State-of-the-art genetic engineering services designed to empower life science firms throughout the drug development lifecycle, including CRISPR-Cas9 technology, gene cloning, and cell line development.
Bio Production Client Solutions
Tailored bio production and contract research services designed to facilitate the development and manufacturing of biological products, offering support across all stages of research and development.
Organ-on-a-Chip Services
Comprehensive microfluidic organ-on-a-chip CRO services designed to mimic human physiological responses for preclinical drug development, toxicity testing, and disease modeling.
Services
Assay development, protein expression and characterization, genetic engineering, and cell line development to support lead optimization and preclinical readiness.
Preclinical study design, animal model selection, GLP bioanalysis, PK/TK analysis, toxicology support, immunogenicity testing and biomarker testing services with regulatory‑ready reporting.
GLP-compliant assay development and validation, clinical PK analysis, toxicology support, immunogenicity/NAb testing, and biomarker analysis to support clinical trials and regulatory submissions.
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.
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.
Method development using QbD and DoE, sequential validation strategies, system suitability testing, statistical analysis and preparation for regulatory inspections and submissions.
Assay development, protein expression and characterization, genetic engineering, and cell line development to support lead optimization and preclinical readiness.
Preclinical study design, animal model selection, GLP bioanalysis, PK/TK analysis, toxicology support, immunogenicity testing and biomarker testing services with regulatory‑ready reporting.
GLP-compliant assay development and validation, clinical PK analysis, toxicology support, immunogenicity/NAb testing, and biomarker analysis to support clinical trials and regulatory submissions.
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.
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.
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
News & Updates
InfinixBio has announced the creation of a new pharmacokinetics division to enhance its capabilities in drug development.
Craig McElroy, Ph.D., has been appointed as Vice President of the new pharmacokinetics division at InfinixBio.
InfinixBio will present its latest anticancer technology at the AACR Annual Meeting in Orlando, Florida.
InfinixBio has appointed Jennifer Logan as its new Chief Marketing Officer to drive business development and strategic growth.
InfinixBio celebrates a significant milestone in Alzheimer’s disease research.
Patents held by InfinixBio
InfinixBio's team comprises of 38% PhDs with over 60 issued and pending patents.
InfinixBio has announced the creation of a new pharmacokinetics division to enhance its capabilities in drug development.
Craig McElroy, Ph.D., has been appointed as Vice President of the new pharmacokinetics division at InfinixBio.
InfinixBio will present its latest anticancer technology at the AACR Annual Meeting in Orlando, Florida.
InfinixBio has appointed Jennifer Logan as its new Chief Marketing Officer to drive business development and strategic growth.
InfinixBio celebrates a significant milestone in Alzheimer’s disease research.
Patents held by InfinixBio
InfinixBio's team comprises of 38% PhDs with over 60 issued and pending patents.