From providing insights into the process unit operations of final product features and quality to setting specifications for release during manufacturing, microbial analytical methods development is the infrastructure of all stages of the product lifecycle. At Cytovance, we have the ingenuity and expertise to develop tailored analytical methodologies and testing plans to guide your molecule through successful development and manufacturing at every scale-up.
With a full suite of development, qualification, and validation capabilities, we tailor specific methods to your molecule at every step during development to measure critical quality attributes and to ensure process performance and robustness. Further, our analytical staff has significant experience in transferring methods and developing standard operating procedures for quality control purposes in manufacturing.
Our Quality by Design-based approaches reveal critical attributes that can impact the stability, function, or appearance of the final product and can be directly assessed by optimized analytical assays. Our experienced team can also optimize the unit operations that drive these features.
The ability to make well-informed go/no-go decisions in the marathon to market is critical. Full microbial analytical methods development integration during early phases of process development can aid in making smart decisions around process parameters that directly affect product critical quality attributes. This can result in streamlined development times and maximized returns on product yield and quality.
Due to the critical nature of monitoring quality attributes for complex microbial expressed products, our labs offer cutting-edge analytical methodologies including high- and ultra-performance liquid chromatography (H/UPLC), capillary electrophoresis (CE), capillary isoelectric focusing (cIEF), and biolayer interferometry (BLI). For product characterization, we employ liquid chromatography coupled to mass spectrometry (LC-MS), multi-angle light scattering (LC-MALS), or dynamic light scattering (DLS). Other standard and compendial methods are established as platforms for use with most products.
Benefit from our full-service cGMP facility with up to 1,000L microbial capacity.
