美国东部时间3月5日，三迭纪联合创始人、首席科学官Xiaoling Li教授将受邀出席在美国华盛顿特区举行的2025国际过程分析与控制论坛（International Forum for Process Analysis & Control, IFPAC），并发表两场主题演讲。

演讲一

主题：Residence Time Distribution Models in MED® 3D Printing Manufacturing

论坛：Enhanced Product and Process Robustness via PAT & Modeling

时间：3月5日13:30-13:55 (UTC-5)

地点：Glen Echo Conference Room

摘要：在药物连续化生产中，停留时间分布（Residence Time Distribution, RTD）在物料追踪、过程理解及控制策略开发等方面具有重要作用。本研究针对熔融挤出沉积（Melt Extrusion Deposition, MED®）3D打印连续化生产线构建的专用RTD模型进行研究和分析。研究结果表明，RTD模型有助于深化对连续制造全流程的认知，提升质量保障体系，加速复杂剂型的开发进程，并为质量源于设计（Quality by Design, QbD）提供工艺优化建议。

完整摘要：

Residence time distribution (RTD) plays an important role in material tracking, understanding of process, and development of control strategy for continuous manufacturing.

Melt Extrusion Deposition (MED®) 3D printing technology is a continuous process, forming a foundation for pharmaceutical product development and continuous manufacturing. RTD models that are relevant specifically to MED® 3D printing continuous manufacturing were developed. For hot melt extrusion unit integrated with loss in weight feeder, RTD models were developed to investigate disturbances and start-stop operation with NIR based methods with varying mass flow rate and different component concentration change. For the 32-channel multi-head printing unit, RTD models were established based on step change measurements via color-marked material. The significant difference RTD models indicate that the flow rate of materials in different printing channels is inconsistent, which facilitates thermostability risk assessment for the constant heating printing processes. Also, the results showed that disturbances in the feed rate can be dampened during propagation of mixing and printing unit operations. According to the RTD models, a 15% inlet disturbance of LWF lasting 45s would be dampened to a label claim (LC) between 95 and 105% at extrusion outlet. But the 45s duration of feeder disturbance could be increased to 20% for the same 5% LC deviation at tablet printing outlet via subsequent printing operation.

The RTD models enable the understanding the process of 3D printing continues manufacturing, contributing to risk assessment and optimization control strategies.

演讲二

主题：3D Printing - A Path to Digital Pharmaceutical Product Development and Manufacturing

论坛：Advanced Technologies from Concept to Reality: Problem(s) Solved Implementation and Integration

时间：3月5日15:35-16:00 (UTC-5)

地点：Linden Oak Conference Room

摘要：不同于依赖经验和试错的传统开发方法，3D打印通过结合药物动力学、体外释放曲线、数字化剂型模型及材料数据库等，开发并验证了“3D打印剂型源于设计”（3D Printing Formulation by Design, 3DFbD®）方法，提高了药物开发的可预测性。此外，全自动3D打印连续化产线集成5种过程分析技术（Process Analytical Technology, PAT）实现了数字化制剂的规模化生产。3D打印技术是一种数字化、连续化和可预测的工艺，可显著提升药品开发效率和成功率，并确保高质量药物产品的商业化生产。

完整摘要：

3D printing is an inherently digital and continuous process, forming a foundation for digital pharmaceutical product development and continuous manufacturing. Traditional product development processes have made steady progress towards a scientific and rational approach since the 1960s. However, due to the large number of variables, current practices still rely on experience and are somewhat trial-and-error based.

3D printing offers digital design of microstructures for dosage forms and digital control in their fabrication. By combining pharmacokinetics, in vitro release profiles, digital dosage form models, and a material database, a Formulation-by-Design approach has been developed and validated. This additional dimension of digitally designed microstructure of dosage forms and material data base reduce uncertainty and accelerates the process by making it more predictable in pharmaceutical product development. Incorporating five in-line Process Analytical Technologies (PATs), a fully automated 3D printing continuous manufacturing production line has been created for the fabrication of digitally designed dosage forms at full production scale.

3D printing paved a path for pharmaceutical product development and manufacturing by providing a digital, continuous, and more predictable process, resulting in significantly enhancing efficiency and reproduced high quality pharmaceutical products.

关于IFPAC：

IFPAC是全球先进制造领域的重要学术交流平台，深耕行业超过35年，汇聚监管机构、制造企业、科研人员及行业用户，覆盖制药、生物技术、化工、食品等领域。会议内容涵盖先进制造、质量源于设计（QbD）、过程分析技术（PAT）、连续制造及过程控制等前沿主题，通过学术交流、技术研讨及行业展示，推动知识共享与合作，助力企业优化运营与技术创新。