COLLEGE STATION, Texas--(BUSINESS WIRE)--Matica Biotechnology (Matica Bio), a leading contract development and manufacturing organization (CDMO) for viral vectors, announced today the successful development of a high-resolution ion-exchange chromatography (IEX) method for analyzing the ratio of empty and full AAV8 (Adeno-Associated Virus 8) viral vector capsids. This significant advancement in the field of cell and gene therapy (CGT) addresses a critical need for improved analytics in CGT manufacturing.
The presence of non-functional, or empty viral vectors, in final drug products is considered an impurity by the FDA, negatively impacting dosage accuracy and drug efficacy. This issue, one of the top challenges in CGT, has been widely recognized in the industry. Matica Bio responded by conducting extensive research, developing an advanced IEX method using HPLC (High-Performance Liquid Chromatography). This method aligns with International Conference on Harmonization (ICH) guidelines, demonstrating high accuracy and precision, while reducing costs and enhancing CGT product analysis.
One of the most surprising findings from the study was the remarkable resolution achieved between empty and full capsids, which often appear indistinguishable in many current analyses. A greater distance between the peaks of full and empty capsids indicates clearer particle separation, leading to enhanced test efficiency and more precise quantitative results. Matica Bio achieved a resolution of at least 10, significantly surpassing the industry average, which typically ranges from 0.5 to 2. Notably, the FDA's minimum requirement for resolution is 2 or higher. This robust method completes the entire analysis in just 30 minutes.
“This innovative method allows us to conduct in-house analyses without the need for costly AUC or mass spectrometry equipment, which can be burdensome for CDMOs and costly for biotech companies,” said Dr. Daniel Mitchell, head of Analytical Development and Quality Control at Matica Bio. “Our approach simplifies the process, aligns with regulatory expectations, and provides reliable data to support our clients’ projects.”
This intensive six-month study not only strengthens Matica Bio's analytical capabilities but also sets the stage for future studies of additional viral vectors, including other AAV serotypes and lentiviruses. The newly developed HPLC method is already being used in various programs as Matica Bio continues to expand its service offerings.
“The development of this HPLC method highlights Matica Bio’s leadership in viral vector manufacturing and development,” said Paul Kim, CEO of Matica Bio. “We are committed to advancing innovative technology solutions that can reduce time, lower costs, and consistently deliver high-quality products to biotech and pharmaceutical partners.”
The full details are available in the article titled "An Improved High-Resolution Method for Quantitative Separation of Empty and Filled AAV8 Capsids by Strong Anion Exchange HPLC," published in Frontiers in Bioengineering and Biotechnology. You can access the publication here.
About Matica Biotechnology
Matica Biotechnology is a viral vector Contract Development and Manufacturing Organization (CDMO) that leverages advanced technologies at its purpose-built cGMP facility. With industry-leading expertise in process development, assay development, and cGMP manufacturing, Matica Bio serves as a trusted partner, seamlessly supporting its clients with streamlined operations throughout every stage of projects. Collaborating across five Matica sites worldwide, Matica Bio delivers excellence in the CDMO domain through innovations such as MatiMax™ proprietary cell lines, in-line process monitoring, and single-use technologies.
To learn more about Matica Bio, please visit www.maticabio.com.
