Avantia Labs is a Contract Research Organization (CRO) specializing in large molecule bioanalysis. Located in Center for Diagnostics Discovery, Horsham PA, Avantia Labs provides PK, immunogenicity, biomarkers, cell-based assay, PCR and real-time PCR services supporting the development of biotherapeutics across many disease states.
We believe that our success is measured by the success of our clients.
Our mission is to help pharmaceutical and biotech companies to advance their biologic drug development to the market and to improve the health of patients. To achieve this, we provide bioanalytical support with scientific excellence, data integrity and regulatory compliance.
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As a CRO, Avantia is committed to establishing a trusted partnership with our clients and becoming an extended laboratory of our clients. We grow our business by earning the trust of our clients through each project and study.
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We strive to offer high quality services with competitive pricing while meeting the most demanding schedules that our clients present to us. To do so, we will build a cohesive and agile team and a reliable quality system to work effectively.
In order to meet the most challenging technical requirement, our team members need to have gone through extensive education and vigorous training in relevant fields and have accumulated extensive academic and industry experience.
We pledge to maintain the highest standard of professional ethics, scientific excellence and regulatory compliance.
Last but not least, we value each and every one of our employees. The most critical part of our service is our people. We are committed to providing a healthy and respectful work environment and the learning opportunity for our people to grow professionally. Each and every one of our employees makes an impact. Collectively, working as a team, we are making a bigger impact on the advancement of drug development.
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Hong Chen, Ph.D. Founder and CEO
Hong has over twenty years’ experience in CRO, biotech, pharmaceutical industry, and academic research with a strong track record of accomplishment. In particular, she has more than a decade of experience in large molecule bioanalysis.
Hong was a Scientific Director at Alliance Pharma, Sr. Scientist at Reaction Biology Corporation, a Principal Scientist at GlaxoSmithKline and Scientist at Stem Cell Therapeutics. Hong earned her doctorate degree in Molecular and Cellular Biology from Temple University. Subsequently, she did a postdoctoral fellowship at the University of Pennsylvania, Perelman School of Medicine in the laboratory of Dr. Mark Kahn.
Hong has published numerous scientific papers in the field of immunology, virology, molecular biology, and vascular biology in multiple scientific journals including Gene and Development, Proc. Natl. Acad. Sci. USA, Blood, Journal of Biologic Chemistry, and Molecular Cell Biology.
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As a GLP/GCP lab, Avantia put sample management as the most important part of our company’s quality system. We believe that the bioanalytical results can only be as good as the quality of the samples. Therefore, an integrated approach to sample management is essential to outstanding bioanalytical quality. We have a complete sample management process in place to ensure optimal sample management and protection.
• Prompt sample receiving and accession into an electronic sample management system
• Secure sample storage in a facility with conrolled access
• Refrigerators and freezers on automated monitoring system 24/7
• Complete control for tracking sample retrieval and movement.
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Avantia implements comprehensive bioanalytical data management and reporting procedures to ensure that the data is reliable, reproducible, and compliant. We uphold the following principles.
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The quality of data starts with our commitment to scientific excellence. We address every quality aspect related to our science, technology, and methodology. With such belief and commitment, we build a solid foundation for quality data.
Data quality also involves effective data organization from data acquisition, data storage, data processing to data reporting over time to ensure accuracy, consistency and compliance throughout every stage of drug development.
We have established the following systems to ensure data security and data accessibility.
Uninterruptible power supply backed up by generator
Our labs are your extended labs. To ensure successful collaboration, for each project we build a project team, led by Bioanalytical Project Manager (BPM) / Principal Investigator (PI). No project is too small. Every project is always of the utmost importance to us.
Each BPM / PI provides active daily in-lab oversight, interfacing between your internal scientists and our scientific team conducting your project through each phase of development.
Acted as a singular point of contact, each BPM / PI holds regular team meeting and provides regular or ad hoc communications with you throughout the project lifecycle to ensure transparency in project progression, on-schedule delivery and within the budget.
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As a GLP/GCP lab, Quality Assurance Unit (QAU), is the most important part of our company. Acted as an independent unit, QAU is responsible for assuring that every project produces data of the highest quality by conducting audits for each study, internal system, and external vendor.The QAU plays a primary role in the development and implementation of Avantia’s Quality System and assures each Standard Operating Procedure (SOP) is comprehensive, accurate, and easy to follow. The ultimate goal of the QAU is to ensure our practice in compliance with all applicable regulations, particularly 21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies and 21 CFR Part 11: Electronic Records and Electronic Signatures.
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Avantia Labs provide large molecule bioanalysis services to support the development of biotherapeutics, including cell and gene therapy from discovery research to preclinical and clinical development. With over 50% of our scientists holding advanced degrees (M.D./ Ph.D.) in biochemistry, molecular biology, cell biology, and immunology, our bioanalytical team is ready to work with you and to conquer any challenges you may encounter. We perform method development, method transfer, customization of commercial kits; method qualification and validation, finally sample analysis.
One of our main business activities is pharmacokinetic (PK) / toxicokinetic (TK) analysis of large molecule biologics from discovery phase to preclinical and clinical phases. We analyze large molecule drug candidates, such as monoclonal antibodies, protein, peptides, enzymes and all their derivatives.
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Our approaches to immunogenicity evaluation are to use the typical classical bridging assay and atypical, less frequently used, direct ligand binding assay, depending upon the available critical reagents and the drug modality. Our evaluation package includes ADA (anti-drug antibody), Nab (neutralizing antibody assay) including cell-based functional assay or binding assay, domain specificity assay, and isotype detection.
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Our fit-for-purpose biomarker assay package includes de novo method development, commercial kit adaptation and customization, multi-plexing to save your resources. Tell us your biomarker need, we will make it for you.
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Our lab is yours for discovery research. We were top-notch scientists in our previous lives; we have probably worked on a similar project as yours before. We are willing to share our experience, to explore and learn new thing from you. The following are just a few examples that we can offer:
• In vitro biochemistry assays
• In vitro binding assays
• Enzymatic Assays
• Cell-based functional assays
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We provide biorepository services for short- or long -term storage of samples and critical reagents. A wide range of storage conditions are available in the state of art sample storage facility with temperature monitoring system and electricity back up generators to ensure sample integrity and security.
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Platforms and instrumentation
• Biotek Synergy H1 Multimode Reader (ELISA)
• Meso Scale Discovery Sector S600 (ECLIA)
• Quant Studio 7 Pro Real Time PCR System (qPCR)
• BioTek Microplate Washer
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