Enabling sustainable biomanufacturing by reducing the use of single use plastics in biopharma with the biocomputer platform

利用生物计算机平台减少生物制药中一次性塑料的使用，实现可持续生物制造

• 批准号: 10073572
• 金额: $ 2.29万
• 依托单位: BIOLOGIC TECHNOLOGIES LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=10073572
• 关键词: Enabling; sustainable; biomanufacturing; reducing; use

BiologIC is the inventor of the biocomputer, a highly integrated and programmable automation platform for producing bio-based products and data on demand. The biocomputer processes components of biological origin, such as cells, nucleic acids, proteins, and biological reagents, into useful products such as therapies. The biocomputer platform can run multiple applications from a common device.The biocomputer comprises four core fluidic chips that can be reconfigured depending on the bioprocessing application or protocol; enabling the system to be used for multiple applications already demonstrated with customer projects, such as advanced cell therapies and small-scale batch mRNA vaccine manufacturing.The next imperative challenge that we face is supporting our customers in their transition to sustainable bioprocessing. Recently there has been a shift in the biopharma industry to move from durables to single use bioreactors. This change was driven by process flexibility, ease to use, small footprint and sterility assurance. However, it has substantially increased plastic waste. With the biocomputer platform we want to provide our customers all the flexibility that single-use systems offer with the additional capability of reusability by integrating cleaning in place (CIP) and sterilisation in place (SIP) in a sustainable way.The biocomputer's architecture inspired by the semiconductor industry is designed to support flexible manufacturing. The system integrates CIP and SIP enabling use as durable, long-term infrastructure. As part of the biocomputer standard architecture we have integrated a "wash circuit". The wash cycle comprises an architecture for distributing solutions around the system to clean and sterilise it for reuse. Additionally, we make use of the same infrastructure used for bioprocessing (eg. impeller, heater) to enhance the cleaning process.There are two main challenges that we are looking to solve with this A4I: (a) the validation of the robustness of our CIP and SIP to avoid microbiological contamination and product cross contamination between cycles and (b) to determine the durability of the 3D printed bioreactor modules.As a lean start up, BiologIC does not have internal resources or equipment for sufficient validation and characterisation or financial resources to pay partners such as NPL and ASTUTE on a commercial basis for the work. Only by collaborating with external expertise through this project can BiologIC optimise and validate the robustness of the CIP and SIP which enable sustainable biomanufacture by allowing re-use of the system for multiple biomanufacturing cycles and applications.

Biologic是Biocomputer的发明者，该发明者是一个高度集成且可编程的自动化平台，用于生产基于生物的产品和需求数据。生物计算器的生物计算器过程（例如细胞，核酸，蛋白质和生物试剂）的成分成疗法等有用的产物。 Biocomputer平台可以从通用设备运行多个应用程序。生物计算机包括四个核心流体芯片，可以根据生物处理应用程序或协议重新配置这些芯片；使该系统可用于已经通过客户项目证明的多个应用程序，例如高级细胞疗法和小规模的mRNA疫苗制造。我们面临的下一个势在必行挑战是支持客户过渡到可持续生物过程。最近，生物制药行业发生了转变，从耐用物转变为单一使用生物反应器。这种变化是由过程灵活性，易于使用，较小的足迹和不育保证驱动的。但是，它大大增加了塑料废物。借助Biocomputer平台，我们希望通过将清洁（CIP）整合到适当的位置（CIP）和以可持续的方式进行灭菌（CIP），以提供单一系统提供的所有灵活性，并以可持续的方式进行灭菌（SIP）。生物计算机的建筑灵感来自半导体行业的启发，旨在支持灵活的制造。该系统集成了CIP和SIP启用用作耐用的长期基础设施。作为生物计算机标准体系结构的一部分，我们集成了“洗涤电路”。洗涤周期包括用于在系统周围分发解决方案的架构，以清洁和消毒以重复使用。 Additionally, we make use of the same infrastructure used for bioprocessing (eg. impeller, heater) to enhance the cleaning process.There are two main challenges that we are looking to solve with this A4I: (a) the validation of the robustness of our CIP and SIP to avoid microbiological contamination and product cross contamination between cycles and (b) to determine the durability of the 3D printed bioreactor作为一个精益启动的模块，生物学没有内部资源或设备来进行足够的验证和表征或财务资源来向合作伙伴（例如NPL和商业基础上的合作伙伴支付）。只有通过该项目与外部专业知识合作，可以生物学优化和验证CIP和SIP的鲁棒性，从而通过允许系统重复使用该系统来实现可持续的生物制造，以进行多个生物制造周期和应用。