Issue link: https://www.e-digitaleditions.com/i/1499694
16 BioPharm International ® Partnerships for Outsourcing eBook May 2023 www.biopharminternational.com Process De veloPment A f ull and comprehensive process characteriza- tion program could typically take a year to complete. However, many factors can inf luence the compres- sion or expansion of its scope and timeline. Case study With every product commercialization, there are op- portunities to adapt a platform approach to the needs and timeline of a product. Though a mAb can readily fit into a platform, this example outlines how the cho- sen platform enabled the collection of extensive data within a fast-tracked timeline. Star ting f rom t he FMEA, t he product was pro- gressed into process characterization. The scale-down models were qualified for the program and then 11 up- stream studies were initiated, assessing expansion, production, media, and raw materials. The scale- down was carried out in an ambr 250 parallel reactor system (Sartorius, Göttingen, Germany). A total of 24 downstream studies were also necessary, with scale- down chromatography in 1 cm columns. The process was made more efficient by moving studies to DoE rather than OFAT, which saved person- nel and material resources. Documents were consoli- dated where possible, using single protocols or reports to serve several studies simultaneously. Some labo- ratory activities were run in parallel, such as using the same cell bank vial to support multiple studies, and samples were also frozen into multiple aliquots, allowing analytics, including size exclusion chroma- tography (SEC), to be performed in batches. With process characterization underway, oppor- tunities to progress the control strategy and other key PPQ inputs were investigated. When mapping out the timelines, it appeared that moving forward with PPQ readiness, while still waiting for the desired process characterization timelines, would not be feasible: work on the control strategy would need to FIGURE 2. Example of process risk analysis. CQA is critical quality attribute.