We specialize in advancing biomedical research through rigorous pre-clinical services. Our thorough evaluations ensure that only the most promising drug candidates progress, setting the stage for successful regulatory approval.
Our expertise spans GLP and non-GLP environments, specializing in assay development, validation, and extensive sample testing. We excel in pharmacokinetic and toxicology studies, animal model selection, and biomarker testing, supporting approvals like 510K and LDT. Partner with us for pre-clinical support that ensures your project meets all regulatory milestones, keeping you integral to every development phase.
Schedule a consultationBioanalytical Method Development
Bioanalytical Method Validation
Dose Escalating Studies - Single Ascending and Multiple Dose
Dose Range Finding
IND-enabling Studies
Pharmacokinetic
(PK) Analysis
Pharmacodynamics
Animal Model Selection
Immunogenicity Testing (ADA Analysis)
Gene Therapy Immunogenicity
Biomarker Testing Services
The InfinixBio team is a diverse and accomplished group of scientists, working collaboratively with the client to ensure projects are completed efficiently, on time and on budget. You can trust that our expert scientists will deliver high quality results.
InfinixBio stands at the forefront, offering solutions that are second to none. Our services encompass ADME assays, PD assessments, and DMPK assays, all conducted with meticulous attention to detail and in compliance with the FDA's GLP guidelines. Our expertise extends to toxicology support and animal model selection, ensuring a holistic approach to drug development.
Pharmacodynamics (PD) in preclinical development refers to the study of the biological and physiological effects of a drug on the body, and the mechanisms through which these effects are exerted. In addition to our PK/PD modeling, we conduct PD studies in vitro and analyze in vivo samples from animal models to establish a drug’s efficacy, potency, and the relationship between drug concentration and the therapeutic effect, thereby guiding dose selection, optimizing therapeutic benefit, and minimizing potential side effects as the drug progresses toward clinical testing.
Choosing the correct animal model for pharmaceutical research is essential for obtaining accurate results. InfinixBio’s animal selection model can save time and money and increase the likelihood of success during the preclinical phase of your research.
InfinixBio can perform full spectrum of ADA screening and analysis for biological test article in matrix. Rapid ADA assay development and validation for biologic molecules. IgG and IgM screening, confirmation and titration assays are developed based on CutPoint determination.
InfinixBio specializes in gene therapy immunogenicity, particularly in the context of AAV-vector-based therapies. PK analysis and toxicology support play pivotal roles in comprehending the immune responses triggered by gene therapy, ensuring treatment success. Our experts offer bioanalytical strategies for all AAV serotypes, covering various types of immunogenicity, including innate, humoral, and cellular responses.
GLP/Non-GLP method development, validation of large and small molecule bioanalysis. Assay development, ELISA, Luminex, FACS, qPCR, Western Blot and commercial assay kits.
Bioanalytical method development involves designing and optimizing analytical techniques to accurately and reliably measure drug concentrations, metabolites, or biomarkers in biological samples such as plasma, serum, urine, or tissues. We select the appropriate analytical platform—such as liquid chromatography-mass spectrometry (LC-MS/MS) and antibody-based approaches (ELISA, EIA, etc.)—as well as optimize sample preparation, chromatographic conditions, and detection parameters to ensure sensitivity, specificity, and robustness.
Bioanalytical method validation ensures the accuracy, precision, selectivity, sensitivity, reproducibility, and stability of analytical methods used to quantify drugs, metabolites, or biomarkers in biological matrices such as blood, plasma, or tissue. We conduct rigorous testing under various conditions to demonstrate that the method consistently produces results within the acceptable limits set by guiding agencies (FDA, ICH, EMA). Validated bioanalytical methods are foundational to interpreting drug absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetic (PK) profiles, supporting decisions about safety, efficacy, and dosing before clinical trials begin.
Dose escalating studies, including Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies, are key elements designed to evaluate a drug’s safety, tolerability, and pharmacokinetics before progressing to clinical trials. Analyzing the samples from rodent and non-rodent animal models, we determine the dosage impacts at various levels, defining safe starting doses for human trials and guiding dose selection.
Dose Range Finding (DRF) studies identify the appropriate dose levels for subsequent toxicology studies and first-in-human trials. In addition to bioanalysis, we provide expert guidance on which animal models are best to evaluate the effects of a range of drug doses, helping to determine the maximum tolerated dose, potential target organ toxicity, and any observable adverse effects.
IND-enabling studies are a series of preclinical investigations required to support the submission of an Investigational New Drug (IND) application to regulatory authorities, such as the FDA, before initiating human clinical trials. We analyze samples from studies, including toxicology assessments, genotoxicity testing, safety pharmacology, and reproductive or developmental toxicity evaluations, in compliance with Good Laboratory Practice (GLP) standards. We identify potential risks, establishing a safe starting dose for humans, and providing robust evidence that the drug is reasonably safe for initial clinical testing.
Each client is assigned a team that consists of a Project Manager (PM), executive contact, senior scientist, and support scientists who will lead the client’s project and work with the client on a one-on-one, fully collaborative basis, streamlining communication and minimizing risk. The PM will be a single point of contact, enabling quick and streamlined communication.
Our scientists are experts in their field and have a total of 50+ issued patents. They have a proven track record of identifying potential issues facing the client and proactively providing innovative solutions to achieve success. This allows the client to continue on the regulatory pathway and overcome obstacles.
Our team understands the regulatory pathway and has extensive experience in the drug development processes. We provide our clients with the knowledge to anticipate future issues while removing barriers to regulatory approval. It’s our goal to ensure your success and longevity for years after working with us.
InfinixBio works collaboratively with clients as a cross-functional disciplinary team, ensuring projects are completed successfully within the agreed timeline and budget. This collaborative approach extends from discovery and proof of concept through preclinical testing and early-stage clinical trial development to regulatory approval.
Our company has overcome complex laboratory-related challenges and has expertise in solving problems unique to each client using an innovative approach. This is supported by our experience across many fields such as drug discovery, pharmacology, and clinical diagnostics.
Each client is assigned a team that includes a Project Manager who acts as a single point of contact. This structure facilitates fast responses and efficient problem-solving, minimizing risks and improving the overall responsiveness to client needs. Our scientists are proactive in identifying potential issues and devising solutions, allowing clients to maintain progress on regulatory pathways.
InfinixBio offers a range of pre-clinical services including GLP and non-GLP assay development, validation, and sample testing. We specialize in pharmacokinetic studies, toxicology studies, animal model selection, and biomarker testing, all supporting crucial approvals like 510K and LDT.
Yes, we tailor our pre clinical services to meet the demands of each project, leveraging our cross-disciplinary teams to ensure that all aspects of the pre-clinical phase align with client objectives and regulatory requirements.
InfinixBio manages data integrity and security through a computer infrastructure that is 21 CFR part 11 compliant, a series of data management SOPs which cover version control of documents, audit trails, and password protected protocols. Additionally, for clients that require certain Government security controls, InfinixBio is compliant with NIST SP 800-171.
InfinixBio has a Quality Assurance Team to oversee and audit all GLP projects to ensure 21 CFR 58 regulations are met.
InfinixBio assigns a dedicated project manager through its Rapid Innovate ModelTM for each project who communicates directly with the client throughout the development process.
