Advance your biotherapeutic entities by partnering with our team to develop stage appropriate analytical methods. We secure your downstream testing success with our precise Quality by Design (QbD) approach, in-depth understanding of macromolecule physicochemical properties, and state of the art analytical instrumentation and columns.
After establishing method feasibility, our team optimizes the process to ensure appropriate resolution and achievable detection limits. Before testing begins, we also determine linearity, precision, accuracy, and specific method development to anticipate acceptance criteria and pre-validation method performance.
From the first step to the last, we provide the analytical implementation needed to advance your biologic with confidence. Our analytical development capabilities cover any potential biotherapeutic modalities, including novel molecules and novel assay development. We have experience completing an extensive array of method development and implementation for assays, including:
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