Beibei Qu

Beibei Qu currently serves as a Scientist/Senior Scientist in Formulation Development at SunGen Pharma, where she plays a pivotal role in advancing the company’s portfolio of generic oral solid drug products. With a strong emphasis on Quality by Design (QbD) principles, Beibei leads the development of multiple projects at various stages, ensuring that each product not only meets regulatory standards but also adheres to the target development timelines. Her hands-on experience spans from bench-top prototyping to pivotal-scale processing, allowing her to effectively bridge the gap between initial formulation concepts and large-scale manufacturing.

In her current role, Beibei is responsible for coordinating with Contract Manufacturing Organizations (CMOs) to execute pivotal batches intended for clinical studies, a critical step in the drug development process. She meticulously prepares the Chemistry, Manufacturing, and Controls (CMC) sections of Abbreviated New Drug Applications (ANDAs), which includes comprehensive pharmaceutical product development reports (PDRs), commercial manufacturing batch records, and quality overall summaries (QOS). Her familiarity with regulatory requirements ensures that all documentation is not only thorough but also compliant with FDA standards.

Beibei's expertise extends to the characterization of reference oral solid dosage forms, including the analysis of active pharmaceutical ingredient (API) particle size and other critical quality attributes. Her proficiency in analytical chemistry techniques, such as High-Performance Liquid Chromatography (HPLC) and crystallization processes, further enhances her ability to develop robust formulations. With a solid foundation in regulatory affairs and a commitment to maintaining Good Laboratory Practices (GLP), Beibei Qu is a valuable asset to SunGen Pharma, driving innovation and excellence in the pharmaceutical industry.