Potency Assay Development Services
Supporting Cell and Gene Therapy
Potency testing is an essential part of developing cellular and gene therapy (CGT) products. The US Food and Drug Administration (FDA) requires sponsors for Investigational New Drug (IND) and Biologics License Applications (BLA) to provide in vitro or in vivo data to demonstrate the potency of the drug product. As such, potency testing plays a critical role in the development and approval of CGT products.
Our Expertise
At Avance Biosciences, we provide comprehensive services to assist our clients in advancing their therapeutic drug development and meeting FDA requirements efficiently and effectively. We use a case-by-case approach to develop, qualify, or validate custom potency assays in accordance with current Good Manufacturing Practice (cGMP) regulations, ensuring that they comply with the necessary standards for GMP product release.
Custom potency assay development
Client potency assay technology transfer
Assay qualification or validation under GMP
Sample testing under GMP
Avance Potency Assay Development Service
Customized Assay Design
We understand that each therapeutic product is unique. Our team works closely with you to design customized potency assays tailored to your specific needs, ensuring an accurate evaluation of your product’s efficacy.
Method Optimization
Our scientists have extensive experience in optimizing complex assays. We carefully assess variables, including critical parameters, sample matrices, and analytical techniques, to develop robust and reproducible assays.
Reliable Bioanalytical Techniques
We employ a range of cutting-edge techniques, including flow cytometry, automated western blot, qPCR, ELISA, ddPCR, and NGS, to measure potency accurately. Our advanced instrumentation and rigorous quality control processes guarantee reliable and precise results.
Regulatory Compliance
We are well-versed in regulatory guidelines, such as those provided by the FDA, EMA, and ICH. Our assays are designed and qualified and/or validated to meet these requirements, ensuring the generation of data suitable for regulatory submissions.
Data Analysis and Reporting
Our team provides comprehensive data analysis and interpretation, delivering clear and concise reports. We ensure that you receive actionable insights and recommendations to support your decision-making process.
Why Choose Avance Biosciences?
Scientific Expertise
Our team consists of highly skilled scientists with vast experience in assay development and the biologics field. We stay up-to-date with the latest advancements to provide cutting-edge solutions for our clients.
State-of-the-Art Facilities
Avance Biosciences is equipped with advanced instrumentation and facilities necessary for developing and executing complex potency assays. We adhere to strict quality control measures to deliver reliable and accurate results.
Timely Delivery
We recognize the importance of timely results in the fast-paced drug development industry. We work efficiently to deliver high-quality data within agreed-upon timelines.
Confidentiality & Data Security
At Avance Biosciences, we prioritize the confidentiality and security of your data. We follow strict protocols to ensure the protection of your intellectual property and sensitive information.