Adeno-associated virus (AAV) mediated gene therapies and any precursor starting materials must be well-characterized to understand the relationship between product quality attributes, manufacturing processes, patient safety and efficacy. Given the variety of AAV serotypes and gene therapy strategies intended to treat a myriad of genetic disorders, there is no "one fits all" off-the-shelf packages for AAV characterization. Our phase appropriate analytical development and method validation capabilities provide the product and process knowledge you need to develop a Quality Target Product Profile (QTPP), identify the Critical Quality Attributes (CQAs) for your therapy, aligned with the Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs), US FDA 2020.
When considering all the factors you need to understand about your AAV therapy, we provide expert insights specifically on your product quality attributes
Every gene therapy is unique. Leverage the expertise of our scientists to ensure compliance, robustness, and efficiency of methods for your viral vector-mediated gene therapy. We are your partner from development through to commercialization, so your therapy can reach patients quickly and safely.
One of the biggest challenges to method development for characterizing a novel viral gene therapy is efficiently using the limited representative R&D material available. With this often-restrained resource, key orthogonal assays to confirm product identity, purity, and potency are essential to understand the molecule and mitigate any potential development risks.
Our Small Volume AAV testing package, arms you with the ability to learn about multiple CQA’s early in development, using reduced quantities of test material, associated with the following characteristics:
To help you de-risk and expedite the product and process development of your AAV therapy, we offer a broad selection of assay packages for various CQA categories and process control points:
We create tailored programs to uncover your AAV vector’s attributes.
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