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Expediting biologics drug development downstream strategies to accelerate preclinical development timelines

Expediting biologics drug development with downstream bioprocessing strategies.


To streamline the path to commercialization, biologics developers should partner with a CDMO with a strong in silico approach to analysis and process development proficiency.l In this whitepaper, Songyoung Kim, Principal Scientist in Downstream Process Development, discusses how our accumulated experience in downstream bioprocessing enables rapid and reliable product development tailored to meet each project’s needs. 


Hurdles in downstream process development for complex biologics


Process development for molecules with varying characteristics requires a customized approach. Even mAbs, for which platform processes are widely implemented, require non-trivial process optimization efforts for each molecule. 

 

Downstream process development aims to achieve both high yields and purity. Platform mAb processes serve as an initial process development framework for many antibody derivatives, including multi-specific antibodies, antibody fragments, fused antibodies, and ADCs; however, the unique characteristics of these complex molecules frequently require substantial modifications from this foundation. Entirely novel downstream bioprocesses may be necessary to accommodate the specific needs of each antibody variant and to ensure the production of high-quality biologics. Whether building on platform processes or engineering novel processes, the approach must be rigorous and include a series of iterative design of experiments (DoE) for resin and parameter screening and optimization.

Expediting biologics drug development with downstream bioprocessing strategies.


To streamline the path to commercialization, biologics developers should partner with a CDMO with a strong in silico approach to analysis and process development proficiency.l In this whitepaper, Songyoung Kim, Principal Scientist in Downstream Process Development, discusses how our accumulated experience in downstream bioprocessing enables rapid and reliable product development tailored to meet each project’s needs. 

 

Hurdles in downstream process development for complex biologics

Process development for molecules with varying characteristics requires a customized approach. Even mAbs, for which platform processes are widely implemented, require non-trivial process optimization efforts for each molecule. 

 

Downstream process development aims to achieve both high yields and purity. Platform mAb processes serve as an initial process development framework for many antibody derivatives, including multi-specific antibodies, antibody fragments, fused antibodies, and ADCs; however, the unique characteristics of these complex molecules frequently require substantial modifications from this foundation. Entirely novel downstream bioprocesses may be necessary to accommodate the specific needs of each antibody variant and to ensure the production of high-quality biologics. Whether building on platform processes or engineering novel processes, the approach must be rigorous and include a series of iterative design of experiments (DoE) for resin and parameter screening and optimization.

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