InfinixBio

The journey to regulatory approval requires expertise and precision. Our proprietary approach, the Rapid Innovate Model™, is a process designed to enhance our clients' success at pre-clinical and early-stage clinical phases to accelerate progress on the regulatory pathway. From discovery to regulatory approval, we provide comprehensive support to move your technology forward. #biotech #innovation #fda #clinicaltrials

Exciting news! InfinixBio has officially secured the trademark for our Rapid Innovate Model™. This milestone underscores our commitment to pioneering swift and effective solutions in biologic drug development. Stay tuned for more innovative breakthroughs! #InfinixBio #RapidInnovateModel

Advancing drug development involves navigating numerous challenges in pre-clinical studies. From testing, analyzing, and evaluating samples to meeting project deadlines, staying within budget, and supporting the IND application for the FDA, each step requires precision and expertise. With the use of proprietary technologies and experience in streamlining these processes, it’s possible to achieve robust and reliable outcomes. Share your experiences with these challenges and explore how our solutions can support your drug development efforts. Learn more about our innovative approaches at: https://lnkd.in/dqp8w6hF #DrugDevelopment #PreClinicalStudies #BiotechChallenges #Pharma #Research

nfinixBio’s team provides insights into regulatory pathways and product development processes, drawing from extensive experience in the biotech industry. We help navigate complex regulatory challenges and ensure compliance with FDA requirements, including 21 CFR part 58 GLP regulations. This compliance is essential for successful IND applications and advancing drug development. InfinixBio covers the intricacies of each stage of product development, from preclinical data collection to clinical trial submissions. Our approach streamlines these processes, ensuring adherence to rigorous standards. InfinixBio’s commitment to excellence and innovation supports long-term success in the biotech field. 🔗Read more: https://ow.ly/Wysy50SMJiY #RegulatoryPathways #ClinicalTrials #FDACompliance

Our team discusses the intricate process of FDA IND submissions for early-stage clinical trials. Submitting an IND necessitates strict adherence to 21 CFR part 58 GLP regulations, crucial for robust preclinical data essential in advancing drug development. This detailed approach helps ensure that all necessary preclinical data are gathered and analyzed properly, paving the way for the successful progression of drug candidates into clinical trials. #FDARegulations #INDSubmission #GLP #PreclinicalStudies #DrugDevelopment

Our team at InfinixBio discusses the intricate process of analyzing both small molecules and large biologics. Using LCMS/MS for small molecules and ELISA for proteins and virus delivery systems, we develop custom assays tailored to new drugs. This ensures precise detection and quantification within various biological systems. For existing drugs, market kits often suffice. However, new drugs with unique compositions require specially developed assays. InfinixBio excels in developing and validating analytical methods to measure drug concentrations accurately in serum and other samples matrices. #Bioanalysis #Biotherapeutics #LCMS #ELISA #DrugDevelopment

Bioanalysis plays a key role in understanding drug behavior within a living organism. It is closely tied to pharmacokinetic (PK) and toxicokinetic (TK) analysis, offering critical data on drug absorption, distribution, and overall impact. The method of drug administration, such as intravenous or intramuscular injections, can significantly affect these results and their subsequent analysis. Our team goes into detail on Bioanalysis, what it is, and how it plays a role at InfinixBio. #Bioanalysis #Pharmacokinetics #Toxicokinetics #DrugDevelopment #ScientificResearch

Antibiotic susceptibility testing is integral to managing infectious diseases, ensuring effective treatments and patient care. InfinixBio recently partnered with a prominent biotechnology company on a novel approach to a rapid antibiotic susceptibility testing technology that aims to improve diagnostic accuracy while accelerating turnaround time. By focusing on efficiency and precision, this advancement represents a promising development in the field of biotechnology, potentially transforming clinical practices and enhancing patient outcomes. 🔗 Read more: https://ow.ly/IeEq50SMIaf #AntibioticTesting #InfectiousDiseases #BiotechInnovation

At InfinixBio, our strength lies in our dedicated team. This month, we're delighted to feature Aaron Zupancic, our Manager and Purchasing Agent. With a BA in History from UC Santa Cruz, Aaron has been with InfinixBio since its inception and its precursor companies. Over the years, he has managed supply procurement, payroll, HR, and more. Aaron looks forward to continuing his journey, meeting innovative people, and learning new skills in his evolving role. #InfinixBio #TeamSpotlight #EmployeeExcellence #Innovation #Dedication

Our latest blog post explores the key methods and strategies for effectively bridging this gap: - Designing informative bioanalytical studies: We discuss selecting appropriate methods to evaluate a drug candidate's pharmacokinetic and pharmacodynamic properties, ensuring valuable data is generated for clinical trial design. - Translational strategies for seamless data integration: Learn about allometric scaling, physiologically-based pharmacokinetic modeling, and in vitro-in vivo correlation - powerful tools to translate preclinical data for human application. - Integrating preclinical and clinical data for success: We explore how to leverage electronic data capture systems, biostatistical analysis, and adaptive clinical trial designs to optimize the drug development process. - Regulatory considerations for a compliant journey: The article explores the importance of the Investigational New Drug (IND) application, communication with regulatory agencies, and post-marketing safety monitoring. - Real-world examples for clear understanding: We showcase successful drug development programs to illustrate the effectiveness of translating preclinical data to clinical trials. #drugdiscovery #clinicaltrials #pharmaceuticalresearch