HJB - Your Trusted Biologics CDMO Partner
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Due to promising clinical development, a client solicited HJB's support to make significant process improvements to their early-stage manufacturing process in preparation for late-stage clinical development and eventual commercial launch. Specifically, the client requested for the conversion of the original fed-batch process to HJB's continuous perfusion platform to significantly increase productivity while maintaining product comparability for NMPA/FDA process change approval.
Employing extensive expertise and experience in CMC development and perfusion process technology, HJB developed and optimized the continuous perfusion process in record time while minimizing changes in key product quality attributes. The process was scaled up successfully on the first try and have completed three 300L production runs since, including DP manufacturing in our newly installed and qualified fill/finish line to secure client's clinical supply. Multiple DS and DP production lots were subjected to extensive comparability assessments using comprehensive analytical and biological tools in which the totality of data confirmed comparability of product produced from the perfusion process to that from the original fed-batch process. A high-quality CMC process change application dossier, supported by extensive comparability data package, was filed, and subsequently received speedy approval from CDE with no major issues. Presently, HJB is conducting process characterization in preparation for process performance qualification (PPQ) and is fully committed to support client's registration filing and commercial launch.
Overall, HJB delivered a much-improved manufacturing process that increased process output by > 8 folds and is projected to reduce cost of goods by >50% when compared to the original fed-batch process while meeting challenging product comparability objectives. The successful completion of this complex project with speed and quality exemplifies HJB's solid foundation and commitment in providing high quality CDMO services to all our clients. In addition to our newly installed GMP DP fill/finish line in 2021, our DS manufacturing capacity was also expanded to better serve our clients' needs.