InfinixBio drives healthcare innovation with cutting-edge clinical development services that transform possibilities into realities. Specializing in GLP-compliant assay development, validation, and extensive sample testing, we excel in pharmacokinetic studies, toxicology studies, and biomarker testing services, including advanced gene therapy.
Our disciplined, cross-functional teams guarantee that your projects meet and exceed regulatory milestones, involving you in every phase. Accelerate your clinical advancements with precision and strategic expertise.
Schedule a consultationWe work collaboratively with clients as a cross-functional disciplinary team, ensuring projects are completed on time, on budget, and successfully progress through the regulatory pathway. While working with InfinixBio, you will be involved in every step of the way.
InfinixBio understands that when it comes to PK, ADME assays, PD assessments, and DMPK assays, it is critical that the bioanalytical method is well-characterized and fully validated. All pharmacokinetic studies are performed with strict compliance with the FDA’s GLP guidelines.
InfinixBio develops and validates Non-GLP/GLP PK Bioanalysis with partial or fully validated LC-MS/MS or ELISA-based assays to screen clinical trial samples.
Toxicokinetic (TK) analysis services for dose range finding, single and repeated dose toxicological study.
InfinixBio can conduct the full spectrum of ADA studies, including Screening, Confirmation Assays, and Titration Assays.
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.
AAV-vector-based gene therapy activates a diverse set of immune responses. InfinixBio provides comprehensive bioanalytical strategies and approaches for all AAV serotypes to all types of immunogenicity covering the innate, humoral & cellular responses. We can also perform a product risk assessment in the host.
GLP/Non-GLP method development, validation of large and small molecule bioanalysis. Assay development, ELISA, Luminex, FACS, qPCR, Western Blot and commercial assay kits.
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 specializes in GLP-compliant assay development, validation, and extensive sample testing. Our services include pharmacokinetic studies, toxicology studies, and comprehensive immunogenicity testing including advanced gene therapies.
Each client project at InfinixBio is led by a dedicated team including a Project Manager, executive contact, senior scientist, and support scientists. This structure ensures one-on-one collaboration, streamlined communication, and minimized risk, making our approach exceptionally client-focused and responsive.
After optimizing the lab manufacturing process and through our technology transfer, InfinixBio works with GMP Manufacturers to efficiently scale up production.
InfinixBio works with its clients to develop approaches to satisfy the regulatory bodies and reduce risk.
InfinixBio is constantly educating and developing staff and researching the latest techniques to ensure the application of new and relevant approaches to our work.
