What Others Say About
Our Pre-Clinical Services

“We came to InfinixBio with a challenge to increase the yield in our manufacturing process of an expensive and complex compound. InfinixBio scientists designed and performed meticulous R&D experiments with effective communication throughout the project. The results led to a ten-fold increase in lab scale product and a 400% improvement in the manufacturing yield.”

Vice President, Bexion
Sandra Nelson, PhD

“InfinixBio has developed and validated multiple complex assays (including ADA and Potency) for our novel therapeutic. Their animal model selection saved us time and money. With the help of their molecular biology expertise, and GLP compliance, we are preparing for an IND submission.”

Chief Technology Officer, Sonnet
Susan Dexter

“We are entering our 10th year working with InfinixBio. They have been crucial in providing expert genetic engineering and cell biology expertise in assisting us expand our product line development of therapeutic compounds.”

Principal Scientist, Protein Biochemistry, Sutro
Dan Groff, PhD

Advance Pre-Clinical Success with InfinixBio

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.

Pre-Clinical

Pharmacokinetic (PK) Analysis

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.

Pharmacokinetic

Toxicological Support

Toxicokinetic (TK) analysis services for dose range finding, single and repeated dose toxicological study.

Toxicological

Animal Model Selection

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.

Animal

Immunogenicity Testing (ADA Analysis)

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.

Immunogenicity

Gene Therapy Immunogenicity

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.

Gene Therapy

Biomarker Testing Services

GLP/Non-GLP method development, validation of large and small molecule bioanalysis. Assay development, ELISA, Luminex, FACS, qPCR, Western Blot and commercial assay kits.

Biomarker

Support for 510(k) and LDT Approval

InfinixBio designs and conducts studies to support both 510(k) and Laboratory Developed Tests (LDT) submissions for medical devices and diagnostic tests.

Support

The Benefits of Pre-Clinical Services with InfinixBio

1. We offer a dedicated project management team.

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.

2. We are subject matter experts.

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.

3. We have regulatory experience.

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.

Why Choose InfinixBio for Your Pre Clinical Research Needs?

1. We are the right development partner.

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.

2. We solve complicated problems.

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.

3. We respond quickly to issues.

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.

Frequently Asked Questions (FAQs)

What pre-clinical services does InfinixBio provide?

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.

Can InfinixBio customize pre-clinical services to fit specific project needs?

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.

How does InfinixBio manage data integrity and security during PK research?

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.

How does InfinixBio ensure GLP compliance in preclinical research environments?

InfinixBio has a Quality Assurance Team to oversee and audit all GLP projects to ensure 21 CFR 58 regulations are met.

How does InfinixBio integrate client feedback during the preclinical development process?

InfinixBio assigns a dedicated project manager through its Rapid Innovate ModelTM for each project who communicates directly with the client throughout the development process.

We take your investment to the next level