合全药业常州基地
随着两个2,000升多肽固相合成釜的启用,WuXi TIDES多肽固相合成釜总体积已超过10,000升。除了多肽产能的大幅提升,WuXi TIDES还新增连续流纯化系统,配备了300-DAC双柱系统,适用于公斤级多肽和寡核苷酸类产品的连续纯化。使用连续纯化模式可缩短纯化周期,降低溶剂消耗,使得多肽和寡核苷酸的生产变得更加高效、绿色环保。
药明康德联席首席执行官、合全药业首席执行官陈民章博士表示:“未来我们将继续提升WuXi TIDES CRDMO平台的能力和产能,加速寡核苷酸、多肽及多种新型偶联药物的开发进程,解决未满足的临床需求,造福全球病患。”
关于合全药业
合全药业是药明康德子公司,在亚洲、北美及欧洲地区均设有研发及生产基地。合全药业服务于生命科学行业,拥有卓越的化学创新药研发和生产的能力和技术平台。作为全球新药合同研究、开发与生产领域(CRDMO)的领军企业,合全药业致力于为全球合作伙伴提供高效、灵活、高质量的一站式解决方案,以支持包括小分子、寡核苷酸、多肽及各种复杂化学偶联药物的研发与生产。更多信息,请访问公司网站:www.stapharma.com.cn
WuXi TIDES Adds New Peptide Manufacturing Capacity and Large-Scale Continuous Purification System
Expansion Enhances WuXi TIDES CRDMO Platform Capability and Capacity for Global Partners
April 6, 2023 - WuXi STA, a global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced that it has added two 2,000 L reactors and a large-scale continuous purification system for peptide manufacturing at the Changzhou campus. The new additions further enhance the capability and capacity of WuXi TIDES. As an integral part of WuXi STA, WuXi TIDES is an end-to-end CRDMO platform for oligonucleotide, peptide, and related synthetic conjugates (“TIDES” drugs), simplifying the TIDES drug development by providing all discovery, CMC development, and the entire manufacturing supply chain under one roof.
With the two new 2,000 L reactors in operation, the total reactor volume of the Solid Phase Peptide Synthesizers (SPPS) at WuXi TIDES has increased to over 10,000 L.
Besides significant peptide capacity expansion, WuXi TIDES also added a new continuous purification system that features 300-DAC twin columns for continuous purification of kilogram-scale peptide and oligonucleotide. The continuous mode enables a purification process with a faster turnaround time and lower solvent consumption, allowing for a more efficient and sustainable peptide and oligonucleotide manufacturing.
Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, said, "We are pleased to support our global partners in their efforts to develop TIDES therapies for patients in need. We are committed to continuously enhancing our WuXi TIDES CRDMO platform's capacity and capability to expedite the development and commercialization of more innovative therapies for patients worldwide."
About WuXi STA
WuXi STA (stapharma.com), a subsidiary of WuXi AppTec, is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations across Asia, North America, and Europe. As a premier Contract Research, Development, and Manufacturing Organization (CRDMO), WuXi STA offers its worldwide partners efficient, flexible and high-quality solutions for integrated chemical, manufacturing and controls (CMC) from preclinical to commercial uses, including the development and manufacturing of small molecule, oligonucleotide, peptide and various complex chemical conjugate. For more information, please visit: http://www.STApharma.com
内容来源:合全药业 药明康德
责任编辑:胡静 审核人:何发
2024-08-17
2024-09-02
2024-08-09
2024-08-06
2024-08-19
2024-08-28
2024-08-15
随着全球化的推进,制药行业面临着提升药品生产效率和质量的双重挑战。过程分析技术 (ProcessAnalytical Technology, PAT) 和连续制造技术 (Continuous Manufacturing, CM) 作为应对这一挑战的关键技术,正逐渐成为制药工业的新趋势。PAT 通过实时监测关键质量和性能属性,为药物生产过程的设计、分析和控制提供了创新的方法。而 CM 技术通过整合多个制药步骤,实现不间断生产,显著提高了生产效率和产品质量的一致性。本文综合分析了 PAT 和 CM 技术的优势、挑战及关键组成部分,并探讨了它们在药品监管和质量保证中的作用。最后,对未来 PAT 和 CM 技术的发展趋势进行了展望,包括技术整合与创新、数据驱动决策、监管科学进步、质量保证提升、生产灵活性和可扩展性、环境可持续性和个性化医疗的实现。这些技术的发展和应用将为制药行业带来深远的变革,提高生产效率,优化产品质量,并满足全球对高质量药品的不断增长的需求。
作者:周国铭、李文龙
评论
加载更多