Manufacturing

Developing Advanced-Therapy Products Through Global CDMOs

Tremendous growth in the cell and gene therapy (CGT) industry is driving unprecedented demand for manufacturing services. To be sure, advanced-therapy developers increasingly are choosing to install in-house capabilities. Doing so can offer companies greater control of their processes, timelines, and budgets than they might have when outsourcing products (1). But industry experts agree that contract development and manufacturing organizations (CDMOs) will remain integral to CGT manufacturing and commercialization (1, 2), especially with veteran contract partners scrambling to acquire CGT…

Dissolved Oxygen Control Tuning for Cell Culture Applications

正确调整溶解氧(DO)控制器比例积分(PI)值对于生物反应器中的最佳细胞培养性能至关重要。当优化DO-PI值时,气体流平滑,泡沫和细胞应力减少。传统上,这种调整是通过使用氮气从测试溶液中清除氧气进行的,从而模拟了氧气需求。但是,该方法有几个缺点。首先,氮气无法模拟高密度发酵的高需求。其次,氮与他人竞争…

电子书:癌症疫苗⁠-创新促进免疫疗法复兴

Despite early successes a decade ago, cancer vaccines designed to deliver peptides or proteins — or nucleic acids encoding those antigens — generally have fizzled out since then. As a result, cancer vaccine development and the field of immunotherapy lost some traction overall. But as freelance contributor Jim Kling describes in this eBook, new innovations in product design, testing, and manufacturing are fueling a renaissance in cancer vaccine development. From checkpoint inhibitors to neoantigens, immune regulators, and beyond, companies are…

eBook: Formulation, Fill, Finish ⁠— Biopharmaceutical Drug Products for a Modern Age

生物制药药物的复杂性正在增加,需要技术进步来解决相关挑战。这本BPI电子书的贡献者强调了药物产品的配方和协作努力,以解决填充的难题。首先,生物生物的斯科特·埃万(Scott Ewan)描述了一种全面的容器 - 覆盖完整性的方法,以及该组织在开发和扩展这种方法方面的工作。Ewan探索了设计分析技术,风险管理和设计(QBD)如何改变与容器 - 覆盖完整性相关的策略,这仍然是一个重要方面……

Translating Inhaled and Nasal Technologies for the Delivery of Biologics

此网络广播功能:Mark Parry,Intertek吸入和鼻腔输送平台的技术总监Mark Parry在其传统用途以外的哮喘/慢性阻塞性肺部疾病(COPD)和季节性鼻炎/鼻窦炎之外还具有特定的应用:它们可以为治疗提供真正的优势生物制剂。在此简短的演讲中,Intertek的技术总监Mark Parry将概述当前可用的技术和成功销售产品,并查看可能遇到的开发挑战,以及可用的解决方案…

The Green Imperative: Part One — Life-Cycle Assessment and Sustainability for Single-Use Technologies in the Biopharmaceutical Industry

大规模的一次性biom以来已经发生了很大的改变anufacturing equipment was introduced some 15 years ago. Since then, these materials have become accepted and established in production and downstream bioprocessing. Concerns about the environmental impact of single-use (SU) biomanufacturing equipment have become more prevalent as our environmental awareness has increased and related concerns have become more urgent (1). For example, many recommendations and even laws have emerged regarding plastic convenience packaging and products (2, 3). People have become more sophisticated in appreciating…

用于上游生物处理的一次性技术的应用

Over the past 10 years, a number of developments in disposable (limited use) and single-use technologies (SUTs) have been made for different bioprocess operations. Until recent years, much of the industry’s process equipment was sterilized using thermal methods such as autoclaving. Most equipment was reusable and required cleaning and sterilization before use. Such processes required validation and expensive and time-consuming resources. Production facilities relied on hard-piped, inflexible equipment such as large stainless-steel bioreactors and holding tanks. However, advanced SUTs now…

病毒载体的基因疗法:通过可扩展的可再现制造过程来利用其潜力

We might not associate the jazz queen Ella Fitzgerald with 21st-century gene-based therapies, but the First Lady of Song was on to something back in 1939 when she sang “’T’Ain’t What You Do (It’s the Way That You Do It).” Although demonstrating the safety and efficacy of gene-based therapies in rigorous clinical trials is essential for gaining product approval from regulators, doing the bare minimum is insufficient. The way that such products are produced also matters. Manufacturing processes and protocols…

Process Intensification of Viral-Based Vaccines: Where Are the Bottlenecks?

In the current coronavirus pandemic, the ability to scale up and produce viral-based vaccines (attenuated viral vaccines, inactivated viral vaccines, and viral vector vaccines) quickly and in large quantities has never before been more relevant. For viral-based vaccines that can be produced by adherent or suspension cell culture, process intensification — in which cell culture, for example, is optimized to produce higher viral titers using the same process equipment — offers a strategy to produce larger numbers of doses in…

在一次性系统设计和实施中管理风险:共同责任

Managing risk in single-use systems design and implementation is a shared responsibility. The ultimate responsibility for drug processes and products will always remain with manufacturers. However, implementation of single-use systems can shift responsibilities to suppliers within key areas, including design and sterilization, which must be clearly controlled and validated. This Special Report discusses how suppliers and manufacturers when working together can mitigate the risk of applying single-use systems in biopharmaceutical production from design through validation to point-of-use testing and operator…