Process Development

We collaborate closely with our clients to design and engineer viral vectors with enhanced transduction efficiency, specificity, and safety profiles. Our expertise in molecular biology and genetic engineering enables us to optimize vector constructs for maximum therapeutic efficacy. This includes, for instance, our in-house developed DirectedLuck® transposase system for the stable integration of packaging genes for the development of efficient producer cell lines.  

We employ cutting-edge cell culture technologies and bioprocess optimization strategies to develop scalable and high-yielding production processes. By optimizing parameters, such as cell line selection, media formulation, and bioreactor conditions, we ensure efficient vector production while minimizing production costs and timelines. In the upstream process, we utilize a range of bioreactor systems to facilitate the efficient growth and production of viral vectors. Our capabilities include the use of wave bioreactors, orbital shaken bioreactors, and stirred tank bioreactors, which allows for precise control over key parameters such as pH, temperature, and dissolved oxygen levels. These bioreactors are optimized for scalability and enable seamless transition from small-scale research to large-scale production. 

Our downstream process development services focus on the purification and concentration of viral vectors to achieve high purity and potency. Filtration is one of the fundamental steps in DSP since it facilitates the removal of cellular debris, host cell proteins, and other impurities while retaining the viral vector particles. Our advanced filtration technologies, including depth filtration and tangential flow filtration (TFF), enable efficient clarification and concentration of the viral vector harvest. 

We leverage the ÄKTA pure^TM system, a state-of-the-art chromatography platform, for protein purification and viral vector purification. This system offers high-resolution separation and purification capabilities, allowing for the removal of impurities and contaminants while preserving vector integrity and functionality. Our chromatographic methods, such as affinity chromatography and ion exchange chromatography, selectively capture and separate viral vectors from contaminants to ensure superior product quality and safety. 

Quality control and analytical testing are integral components of our process development workflow. We utilize a comprehensive suite of analytical techniques, including ddPCR and qPCR, ELISA, SDS-PAGE, next-generation-sequencing (NGS), and DLS-based particle measurements as well as sophisticated cellular assays, to assess vector integrity, purity, and potency at various stages of development. Detailed information about our comprehensive analytical methods can be found here: Quality Analytics. 

We understand the complex regulatory landscape surrounding viral vector-based therapeutics and provide comprehensive support to facilitate regulatory submissions and approvals. Our team assists clients in compiling regulatory documentation, conducting risk assessments, and navigating regulatory requirements to ensure compliance with global regulatory agencies. 

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