Genetic therapies are providing new hope for vaccinees as well as previously incurable diseases, but they also present new challenges for process development and control. The sheer size and complexity of products like pDNA, mRNA and AAV present a new challenge for "at-line" analytics, like distinguishing sc/oc/lin pDNA or empty from full AAV capsids.
At BIA Separations, we are passionate about providing the best solutions for gene therapy purification, by providing a modality-specific platform for analysis and in-process control of new generation gene therapy products.
To achieve this, we have built our platform on 4 key pillars:
Process development and production of gene therapy products brings together people with different skills and specializations, hence PATfix software is built to address the needs and solve challenges of each. An integral part of the PATfix value proposition, the PATfix software strips away the complexity of chromatography at the day-to-day operational level, while retaining it for higher level tasks.
CIMac™ analytical columns, are a perfect tool for chromatography of large gene therapy products due to convective laminar flow, a large accessible surface area required for product binding and a variety of surface chemistries. These in turn allow us to tailor the PATfix platform for best results irrespective of gene therapy product.
Featuring bio-inert ceramic pump heads, and flow rates up to 10 mL/min (quaternary pump), PATfix is designed to extract maximum analytical information for a wide range of biological products. A highly sensitive, multi-wavelength UV detector, as well as a fluorescence detector, capture component peaks, even with the steepest gradients.
Its not just about the individual building blocks, its knowing exactly which blocks are required and how they need to work together to achieve their stated goal – provide analytical insight at every step of gene therapy process development and production. Gaining this level of insight requires a lot of trial and error to perfect. We have developed and transferred methods for both analytics and production of gene therapeutics to many customers. The experience gained on such a variety of products and projects has allowed us to develop a set of chromatographic methods, that can encompass a variety of products and can be applied to key steps of PD and production.