Frequently asked questions
What modalities can your analytical development teams support?
Our analytical capabilities support biologics, gene therapy, and cell therapy programs. Analytical strategies are tailored to the characteristics of each product, its manufacturing process, stage of development, and the intended use of the method.
Can you develop analytical methods from the ground up?
Yes. We support analytical method development, optimization, qualification, validation, and transfer. Methods can be developed for new products or transferred and adapted from existing programs.
What analytical capabilities do you have for viral vectors?
Our viral vector capabilities combine molecular, physicochemical, biophysical, and functional analytics, including AUC, ddPCR and other PCR-based methods, capsid and genome characterization, purity assessment, and cell-based functional assays.
Can you support plasmid DNA analytical development?
Yes. We support characterization of plasmid DNA identity, concentration, purity, topology, supercoiled content, integrity, and relevant process- and product-related impurities, alongside analytical support for process development.
What analytical capabilities support cell therapy programs?
Our cell therapy analytical capabilities combine cellular, molecular, and functional approaches, including flow cytometry, cell identity and phenotyping, viability assessment, qPCR and ddPCR-based methods, and cell-based functional assays. Analytical strategies are tailored to the characteristics and intended function of the cell therapy product.
Do you develop potency and functional assays?
Yes. We develop cell-based, binding, and other functional assays tailored to the biological activity and intended mechanism of action of the product.
Can you transfer analytical methods developed elsewhere?
Yes. Client or third-party analytical methods can be transferred and assessed for their intended application. Where required, methods can be optimized, qualified, or validated as part of the transfer.
How are analytics integrated with process development and manufacturing?
Our analytical and process development teams work together throughout development, enabling analytical data to inform process optimization, characterization, scale-up, technology transfer, and preparation for GMP manufacturing.
