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

Navigating drug development involves significant challenges in pre-clinical hurdles, including rigorous testing, analysis, and evaluation of samples, meeting project deadlines, staying within budgets, and preparing FDA IND applications—all requiring precision and expertise. To overcome these challenges we: • Leverage proprietary technologies to streamline processes • Ensure reliable outcomes in drug development • Continuously innovate and support the transition from pre-clinical stages to successful clinical trials Share your experiences with these challenges in the comment section! or learn more about our innovative approaches at: https://lnkd.in/dqp8w6hF #DrugDevelopment #PreClinicalStudies #BiotechChallenges #Pharma #Research

When biologic drugs are administered, the immune system may produce anti-drug antibodies (ADAs) against the medication. These ADAs can attach to the drug, diminishing its effectiveness and potentially leading to treatment failure. ADAs can vary in their impact, with some causing mild reactions while others can lead to severe consequences such as allergic reactions or loss of therapeutic response. InfinixBio explains the impact of ADAs on biologic treatments and highlights the importance of understanding them for successful therapy. Recognizing the presence and behavior of ADAs is crucial for optimizing biologic drug efficacy, ensuring patient safety, and guiding adjustments in treatment protocols. Moreover, the FDA requires the evaluation of ADAs for the approval of biologic drugs to the next stage, emphasizing their significance in the drug development process. #AntiDrugAntibodies #BiologicDrugs #MedicalScience

At InfinixBio, our diverse team of accomplished scientists collaborates closely with clients to ensure that projects are not only completed efficiently but also align with both time and budget constraints. Trust in our expertise to deliver high-quality results that advance your research objectives. #Biotech #Preclinical #preclinicaltrials #pharmacokinetics

Exploring the complexities of gene therapy, InfinixBio is at the forefront of assessing and managing immunogenicity to enhance therapy safety and effectiveness. Our expert team specializes in comprehensive immunogenicity assessments, utilizing cutting-edge bioanalytical techniques to study immune responses across various AAV serotypes. #GeneTherapy #BiotechInnovation #InfinixBio

We're dedicated to advancing gene therapy through comprehensive immunogenicity assessments. Specializing in AAV vectors, we provide detailed PK analysis, toxicology support, and develop both ADA and NAb assays. This meticulous approach helps us manage immune responses effectively, ensuring the safety and efficacy of therapies. Curious about how we support gene therapy projects? Visit our website to learn more about our critical role in the development of innovative treatments. #GeneTherapy #Immunogenicity #Biotech

Tom Zupancic, our Chief Scientific Office, recently shared his insights at the Ohio House of Representatives, advocating for the transformative potential of House Bill 434. This bill aims to position Ohio as a leader in developing effective therapies for traumatic brain injuries and other neurodegenerative conditions. As a board member of the Brain Injury Research Foundation (BIRF), Tom was one of six expert presenters. He highlighted the urgent need for innovative treatments and the role that comprehensive programs like PRECEPT and SynapFx could play in revolutionizing TBI research and therapy. By fostering statewide collaboration and leveraging multiomics data for combination therapies, we can enhance our approach to these pressing health challenges.  #Neuroscience #TraumaticBrainInjury #GeneTherapy

Gene therapy holds great promise in treating a range of diseases by correcting genetic errors at their source. Before these innovative therapies can reach clinical trials, however, they must navigate a series of rigorous preclinical challenges. These include: - Ensuring the precision of gene editing techniques. - Validating therapeutic targets. - Conducting comprehensive safety assessments. - Demonstrating proof of concept effectively. We’re interested in hearing about your experiences in this complex phase. #GeneTherapy #BiotechInnovation #CRO

At InfinixBio, we're committed to advancing research and support the development of innovative treatments that one day might reverse or halt the progression of this challenging disease. This month, we encourage you to join us in raising awareness, increasing support for research, and taking proactive steps toward brain health. Together, we can forge a path to a future where Alzheimer's no longer takes away our loved ones' memories. #EndAlz #AlzheimersAwerenessMonth #AlzheimersResearch 

From cancer to genetic disorders like cystic fibrosis and diabetes, gene therapy offers a new horizon of hope. At InfinixBio, we are proud to be at the forefront of this research, supporting the development and application of these life-changing therapies. #GeneTherapy #InnovativeMedicine #InfinixBio #BiotechCRO