The development of a robust and reliable cGMP manufacturing processes for cell and gene therapies largely depends on the implementation of appropriate in-process monitoring and control analytics, as well as comprehensive characterization of the product. This requires modelling all of the mechanisms of action associated with the product, identifying the potential Critical Quality Attributes (CQA) of the product in relationship with the potential Critical Materials Attributes (CMA) and potential Critical Process Parameters (CPP) in the development phase. In some cases, this is critical to manufacturing high quality product and meeting safety and therapeutic efficacy requirements.
Our Assay development activities begin with performing a feasibility assessment of the existing analytical methods during the early development phase, when your process and methods are transferred to our development labs. This is followed by a gap assessment of the existing protocols considering each type of assay and ICH guidelines.
The diagnosis results in a detailed report on the status and needs of your product to reach commercialization, including recommendations to establish appropriate and necessary CQAs and demonstrate the Safety, Identity, Strength, Purity and overall Quality of your product.
By leveraging years of experience in developing, optimizing, qualifying and validating assays across CGT modalities, we have built a proprietary library of pre-developed, fast-to-qualify assays for a range of modalities including iPSC therapies, immunotherapies (CAR-Ts), cell therapies and viral vectors. Our library of fast-qualified assays for cell and gene therapies include safety, identity, strength, purity and overall quality of the product. Following an evaluation of your process, our team recommends a suite of assays from our library of established pre-developed assays, based on your therapy, if applicable.
Once your assays are established in the process development laboratories, our Assay Development team is responsible for training Quality Control technicians. They will lead the activities relevant to level 1 assay validation or qualification in the QC laboratory, where we ensure that your product can be manufactured under GMP and meet your target product profile.
As your program advances to late phase clinical trials, we perform assay robustness studies first to ensure the assays are reliable and meet the intended use. We then perform level 2 validation studies as one of the key requirement for commercialization of your product.
Vice President, Sales and Program Management, CGT Business Unit