产业化不只是放大:一项创新药背后的全流程协同

一款创新药从实验室走向临床和注册，不仅需要源头创新，也考验后续开发、工艺放大、质量控制和规模化生产等环节能否高效衔接。

近期，一款1类创新药获国家药品监督管理局批准上市，实现了源头创新向临床应用与产业化落地的重要跨越。自相关原料药工艺完成转移后，在客户团队的统筹推进下，九洲药业作为CDMO合作伙伴，协助开展原料药工艺优化、质量研究、生产放大、工艺验证及制剂产业化等工作。

9个月，8个批次

把研发与生产拉到同一节奏

项目进入关键开发阶段时，客户需要在约9个月内完成长毒批次、关键临床批次及工艺验证批次的研发与生产，并按计划推进工艺验证。面对紧凑的时间窗口，九洲药业协调研发、工程、生产与质量团队同步启动，将工艺评估、设备适配和质量研究并行推进。

项目启动后，九洲药业团队在工艺复核中发现，早期工艺在放大生产中仍面临工艺稳健性、设备适配及关键中间体质量控制等挑战。双方保持高频沟通，并行推进多个技术方向的验证。九洲药业项目团队在较短时间内开发出适用于百公斤级生产的新工艺，同步推进质量研究和关键中间体质量控制，并实现从20 kg到100 kg规模的设备适配与工艺衔接。

最终，项目在9个月内完成8个批次交付。其中，工艺验证阶段仅用46天，并实现零偏差、零异常，为客户后续审评及项目推进争取了更多时间。

从API到制剂

进一步解决稳定转化与精准评价

项目进入制剂产业化阶段后，API物料特性、处方组成与实际生产条件之间的匹配，成为影响放大稳定性和可制造性的关键。针对高载药量带来的可压性挑战及潜在生产风险，九洲药业项目团队围绕物料属性、处方变量与设备参数开展系统分析，识别影响生产稳定性的关键因素，并制定针对性优化策略，最终在产线端实现稳定生产。同时，研发团队基于API的溶出特性与释放机理，开发了具有较高区分力、并具备体内外相关性（IVIVC）潜力的溶出介质方法，为处方筛选、工艺优化及后续质量控制构筑了坚实的方法学基础。

不只解决一个节点

九洲的小分子一体化CDMO能力

面向小分子创新药，九洲药业已建立覆盖工艺路线筛选与优化、分析方法开发与质量研究、工艺安全评估、放大生产、GMP供应、制剂开发及商业化生产的一体化CDMO能力体系，可支持项目从临床前开发、临床样品供应到工艺验证和商业化生产的连续推进。

在项目执行中，原料药与制剂团队可从项目早期协同介入，围绕物料属性、杂质控制、处方适配性、设备参数及关键质量属性开展联动评估。通过跨专业项目团队和全生命周期质量管理，九洲药业帮助客户减少跨环节的信息损耗与后期反复，使技术决策、生产节奏和质量要求保持一致。

依托小分子原料药与制剂一体化CDMO能力，九洲药业将继续与创新药企业和科研团队紧密协作，以跨专业协同和稳健交付推动更多具有临床价值的创新成果从实验室走向市场。

Nine Months. Eight Batches. Zero Deviations. How an Innovative Drug Program Cleared Critical Scale-Up Hurdles

Bringing an innovative drug from the laboratory into clinical development and regulatory registration requires not only scientific innovation, but also seamless coordination across downstream development, process scale-up, quality control, and large-scale manufacturing.

Recently, a Class 1 innovative drug received marketing approval from China's National Medical Products Administration (NMPA), marking an important step from scientific innovation to clinical application and commercialization. Following API process transfer and under the client's overall coordination, JiuZhou Pharma served as the CDMO partner, supporting API process optimization, quality studies, manufacturing scale-up, process validation, and drug product development for commercial-scale manufacturing.

Nine Months, Eight Batches: Aligning Development and Manufacturing

As the program entered a critical development stage, the client needed to complete the development and manufacturing of long-term toxicology batches, key clinical batches, and process validation batches within approximately nine months, while keeping process validation on schedule. Given the compressed timeline, JiuZhou mobilized R&D, engineering, manufacturing, and quality teams in parallel, advancing process assessment, equipment adaptation, and quality studies simultaneously.

After project initiation, JiuZhou's process review found that the early-stage process still faced challenges in process robustness, equipment adaptation, and key intermediate quality control during scale-up. The two teams maintained frequent communication and advanced several technical workstreams in parallel. Within a short timeframe, JiuZhou developed a new process suitable for 100 kg-scale manufacturing, advanced quality studies and key intermediate controls, and achieved equipment adaptation and process integration from 20 kg to 100 kg.

The program ultimately delivered eight batches within nine months. The process validation phase was completed in just 46 days, with no deviations or unexpected events, creating additional time for the client's subsequent regulatory activities and program advancement.

From API to Drug Product: Enabling Robust Manufacturing and Precise Evaluation

As the program advanced toward commercial-scale drug product manufacturing, alignment among API material attributes, formulation composition, and actual manufacturing conditions became critical to scale-up robustness and manufacturability. To address compressibility challenges associated with high drug loading and potential production risks, JiuZhou's project team systematically analyzed material attributes, formulation variables, and equipment parameters, identified the critical factors affecting manufacturing stability, and implemented targeted optimization strategies that enabled stable production on the manufacturing line. In parallel, the R&D team developed a highly discriminatory dissolution method based on the API's dissolution behavior and release mechanism, with the potential to support an in vitro-in vivo correlation (IVIVC). The method provides a sound basis for formulation screening, process optimization, and ongoing quality control.

Beyond a Single Milestone: JiuZhou's Integrated Small-Molecule CDMO Capabilities

For small-molecule innovative drugs, JiuZhou Pharma has established integrated capabilities spanning route scouting and process optimization, analytical method development and quality studies, process safety assessment, scale-up manufacturing, GMP supply, drug product development, and commercial manufacturing. This platform supports continuity from preclinical development and clinical supply through process validation and commercialization.

API and drug product teams can engage early and work together across material attributes, impurity control, formulation compatibility, equipment parameters, and critical quality attributes. Through cross-functional program teams and lifecycle quality management, JiuZhou helps reduce information loss and late-stage rework across development interfaces, keeping technical decisions, manufacturing timelines, and quality requirements aligned.

Leveraging its integrated small-molecule API and drug product CDMO capabilities, JiuZhou Pharma will continue to collaborate with innovative pharmaceutical companies and research teams, using cross-functional coordination and reliable delivery to help advance more clinically meaningful innovations from the laboratory to the market.