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

Developing lab-developed tests (LDTs) is about more than just science—it requires a strategic plan from start to finish. At InfinixBio, we provide full support to ensure your tests meet the highest standards of accuracy and regulatory compliance. We work with you at every stage, from fine-tuning your methods to navigating the complex regulatory process. But our support doesn’t end once your test is approved. We continue to monitor performance, adapt to new data, and stay on top of evolving regulations to ensure your test has a lasting impact. Swipe through to see how we make the journey smooth and successful. #LDTDevelopment #Diagnostics #InfinixBio #ClinicalResearch #RegulatoryCompliance

Patents are more than legal protection; they’re important tools for business growth. They help secure funding, provide market freedom, and offer exclusive rights to use and sell innovations. At InfinixBio, our scientists are listed as inventors on over 30 biotechnology patents. We also assign patent ownership to our clients, giving them a competitive edge in research and development. A strong patent strategy can open new markets, drive innovation, and protect your discoveries. Swipe through to see how patents support your drug development journey. #DrugDevelopment #PatentProtection #HealthcareInnovation #InfinixBio

We're proud to have partnered with Sutro Biopharma, Inc. as we approach 12 years, providing advanced genetic engineering and cell biology expertise. It's collaborations like these that drive innovation and push the boundaries of therapeutic development. Thank you, Dr. Dan Groff, for recognizing our commitment to expanding the potential of biotech solutions. Here’s to many more years of pioneering progress together! #InfinixBio #BiotechLeadership #GeneticEngineering #TherapeuticInnovation

The journey from discovery to diagnostics success requires more than expertise; it needs a reliable partner. At InfinixBio, we tackle challenges with tailored CMC (Chemistry, Manufacturing, and Controls) solutions to meet your project's unique needs. CMC ensures the quality, safety, and efficacy of drug products at every stage, from early development to clinical trials and commercial release. It covers the chemical properties, manufacturing process, and control systems for consistent quality. With dedicated project managers, streamlined communication, and hands-on technology transfer, we help move your project forward with precision and confidence. Want to know more? Read the full article. #DrugDevelopment #CMC #Biotech #Pharmaceuticals #QualityControl #RegulatoryCompliance #InfinixBio #FDAApproval #Chemistry #Manufacturing

The journey from discovery to diagnostic success requires not just expertise, but a partnership you can rely on. At InfinixBio, we navigate complex challenges by developing custom solutions that fit your project's needs. Our team works closely with CROs, engineers, and clinical labs to ensure precise and reliable assay development for 510(k) and LDT submissions. Our streamlined process includes dedicated project managers who act as your single point of contact, facilitating smooth communication and rapid problem-solving. From early concept design to hands-on technology transfer, we’re here to move your diagnostic project forward with precision and confidence. #DiagnosticDevelopment #AssayDevelopment #510kSubmissions #InfinixBio #HealthcareInnovation

October marks National Breast Cancer Awareness Month, a time to honor those affected and to raise awareness about the importance of early detection and ongoing research. We take this moment to reflect on the advancements in cancer research, knowing that every step forward brings us closer to better treatments and outcomes. #BreastCancerAwareness

🧬 The process of developing diagnostic tests involves navigating numerous technical and regulatory challenges. From initial concept to final approval, each phase demands a high level of expertise and coordination. We're interested in understanding where professionals in the field encounter the most significant obstacles. Your input will help identify critical areas for improvement, driving advancements in the way we approach diagnostic test development. #Diagnostics #Biotech #RegulatoryCompliance #InfinixBio

InfinixBio proudly partnered with a pioneering biotech firm to advance cancer treatment through a cutting-edge microbial-based immunotherapy platform targeting solid tumors. Our mission: to develop a bacterial strain capable of precise tumor localization and effective therapeutic delivery. Key Highlights: 🧬 Engineered bacterial strains using precision genome editing. 🔬 Ensured targeted delivery to the tumor microenvironment. 📊 Reduced development risks, leading to a Phase 1 clinical trial of the lead drug candidate. Read the full case study to learn more about our innovative approach and impactful results. https://lnkd.in/deZ3Fzvh

At InfinixBio, collaboration is more than a partnership—it’s the driving force behind innovation. We team up with visionary biotech firms, forward-thinking consultants, and dynamic pharmaceutical companies to push the boundaries of what’s possible in healthcare. Here’s how we make it happen: 🔬 Immunogenicity Expertise: We identify and mitigate immune responses to ensure your biologic therapies succeed. 🧬 Precision Biomarker Analysis: Our advanced techniques unlock insights that personalize patient care and enhance treatment outcomes. 🧪 Comprehensive Preclinical Studies: From concept to clinic, we provide the rigorous research needed to bring new therapies to life. Every project we undertake is guided by our commitment to excellence and a shared goal of transforming patient care.