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Mingjie Pharma's inaugural national CMC pharmacy salon tour for 2025 concludes successfully | Wanbangde Pharmaceutical deeply engages in technical exchanges
Date:
14 Apr,2025
On March 1, 2025, the first stop of Mingjie Pharmaceutical's "2025 National Tour Salon on Comprehensive CMC Research Strategies for Pharmaceuticals" was successfully held at Wanbangde Pharmaceutical Group Co., Ltd. With the theme "Empowering the Entire Lifecycle of Drug Development and Building a New Ecosystem for Quality Research," the event drew full participation from Wanbangde's entire R&D team. Together, both teams engaged in an in-depth dialogue on critical quality research issues throughout the drug development and manufacturing process, jointly exploring emerging trends in industry technology.
Strong partnership, jointly ushering in an academic feast
At the event's outset, Dr. Zhao Guanjia, Dean of Wanbangde Pharmaceutical Research Institute, delivered the opening remarks. Dr. Zhao highlighted that, amid the globally tightening regulatory environment for pharmaceuticals, the systematic and forward-looking nature of CMC research has become a key competitive advantage in both new drug development and generic drug applications. He highly praised Mingjie Pharma for its strong technical expertise in drug quality research and expressed his anticipation that this seminar would inspire innovative ideas within Wanbangde's R&D team.
In his speech, Zhu Zifeng, Deputy General Manager of Mingjie Pharmaceutical, emphasized that this nationwide salon tour aims to establish a robust platform for in-depth technical exchanges between pharmaceutical companies and CROs. He systematically outlined Mingjie Pharmaceutical’s strategic approach to end-to-end CMC services, with a special focus on sharing insights from "Requirements for Organic Impurity Control in Drug Registration and Case Studies on Supplementary Information Requests." By thoroughly analyzing the latest review cases from the FDA, EMA, and NMPA, he helped on-site R&D professionals develop a comprehensive impurity control strategy framework rooted in the QbD (Quality by Design) philosophy.
Five Key Topics Tackle the Pain Points of CMC Research
During the technical sharing session, Mingjie Pharmaceutical's expert team delivered a comprehensive thematic report—presented through an integrated online-and-offline approach—that covered the entire chain of pharmaceutical quality research.
1. Breakthrough in High-Resolution Mass Spectrometry Technology
Director Chen Bing, in his presentation titled "Application of High-Resolution Mass Spectrometry in Pharmaceutical Quality Research," showcased innovative approaches for enhancing method development efficiency using HRMS, drawing on real-world examples such as genotoxic impurity identification and structural elucidation of unknown degradation products.
2, Innovations in Crystal Formulation Technology
Dr. Sun Zhonglin, in the special session titled "Pharmaceutical Polymorph Research Empowers New Drug Development," systematically outlined a comprehensive, full-cycle solution—from screening for advantageous polymorphs of new drugs to ensuring polymorphic consistency in generic formulations—and shared a cutting-edge research paradigm that integrates AI-driven predictions with experimental validation.
3, Sterile Production Quality Control
Vice General Manager Lü Fang provides an in-depth analysis of "Sterile Drug Filtration Filter Validation," covering everything from regulatory compliance and process validation design to data integrity management, thereby establishing a systematic validation framework that meets FDA’s sterility guidelines.
4. R&D Quality Management Upgrade
Dr. Zhang Chuhang, in his report titled "Management of Deviation Changes During the R&D Phase," systematically explains deviation management within the R&D quality management system, drawing from a wealth of real-world case studies. He emphasizes that managing deviation changes in the R&D phase is not only a compliance requirement but also a crucial lever for enhancing R&D efficiency and mitigating project risks.
5, Advanced Packaging System Validation
Vice General Manager Lin Chunxin, in his presentation titled "Best Practices for Pharmaceutical Packaging Compatibility and Seal Integrity Studies," compared and analyzed the similarities and differences between regulatory requirements in China, the U.S., and Europe, and shared a standardized operational procedure for seal integrity studies based on the Q3C guidelines.
Deep integration of industry, academia, and research sparks innovation momentum.
During the Q&A session, attendees engaged in a lively discussion on several technical challenges, including strategies for setting impurity limits, confirming the structures of unknown impurities, conducting compatibility studies between packaging materials and peptide-based drugs, and evaluating co-linear production processes. President Zhao remarked: "The Mingjie expert team’s insightful interpretation of ICH guidelines, combined with their innovative application of cutting-edge technologies, has provided us with invaluable insights into optimizing critical quality research pathways for several innovative drug projects we’re currently advancing." As the event drew to a close, a thrilling lottery draw further intensified the atmosphere, with multiple R&D leaders winning exquisite gifts from Mingjie Pharma, such as the "FDA Warning Letter Review and Case Study Guide."
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