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是生物计算机的发明者，这是一种高度集成和可编程的自动化平台，用于按需生产生物产品和数据。生物计算机处理生物来源的组分，例如细胞、核酸、蛋白质和生物试剂，成为有用的产品，例如疗法。生物计算机平台可以从一个共同的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，其可以根据生物处理应用程序或协议重新配置;使得该系统能够用于已经在客户项目中演示的多个应用，例如先进的细胞疗法和小细胞疗法，大规模批量mRNA疫苗生产。我们面临的下一个紧迫挑战是支持我们的客户向可持续生物加工过渡。最近，生物制药行业发生了转变，从耐用品转向一次性生物反应器。该变更是由工艺灵活性、易用性、占地面积小和无菌保证驱动的。然而，它大大增加了塑料垃圾。通过生物计算机平台，我们希望为客户提供一次性系统所能提供的所有灵活性，并通过可持续的方式集成原位清洁（CIP）和原位灭菌（SIP），提供额外的可重复使用能力。生物计算机的架构受半导体行业的启发，旨在支持灵活制造。该系统集成了CIP和SIP，可用作持久的长期基础设施。作为生物计算机标准架构的一部分，我们集成了一个“清洗电路”。清洗循环包括用于在系统周围分配溶液以对其进行清洁和灭菌以便重复使用的架构。此外，我们还利用与生物加工相同的基础设施（例如，叶轮，加热器），以加强清洁过程。有两个主要的挑战，我们正在寻找解决这个A4 I：（a）验证我们的CIP和SIP的稳健性，以避免微生物污染和循环之间的产品交叉污染，以及（B）确定3D打印生物反应器模块的耐用性。作为精益启动，BiologIC没有内部资源或设备来进行充分的验证和表征，也没有财务资源来支付NPL和ASTUTE等合作伙伴的商业工作费用。只有通过该项目与外部专家合作，BiologIC才能优化和验证CIP和SIP的稳健性，通过允许将系统重复用于多个生物制造周期和应用，实现可持续的生物制造。