Enhanced Biopharmaceutical Release: Autonomous PAT Power

Speeding up biomanufacturing using automated Process Analytical Technology (PAT) systems

A2P2 and Micro Sequential Injection (SI), two cutting-edge process analysers, have been cited as autonomous PAT platform that enables quick testing and release of biopharmaceutical products.

An insight has showcased two innovative, automated, real-time sample acquisition and preparation systems for monitoring, controlling, and releasing biopharmaceuticals during manufacturing. The proposed autonomous PAT platform includes a µSI process analyser and A2P2, which can be used in laboratory and manufacturing floor settings, ensuring swift testing and release of products produced under good manufacturing practice (GMP) standards.

It emphasises the importance of real-time monitoring and control in biomanufacturing processes to gain insights into product quality, a critical area of focus in the biopharmaceutical industry.

According to insights, the delays caused by traditional offline analytical testing can hinder process development speed. Therefore, incorporating analytical technologies becomes necessary to accelerate the development process.

The insight highlights that implementing an innovative analytical strategy is crucial for building resilience, managing manufacturing quality risks, and gaining a competitive edge in the industry. The adoption of automated systems aims to facilitate routine and on-demand acquisition of essential product quality and process performance attributes in laboratories and manufacturing facilities.

The proposed autonomous PAT platforms offer 24/7 monitoring, reliable performance, and resource agility, which contrasts with traditional analytical approaches relying on manual sample acquisition and preparation workflows that are more susceptible to errors.

Micro sequential injection (µSI) is the chosen technology for its advantages in fluidic miniaturisation, such as lower material consumption and faster analysis. The instrument’s design reduces sample and reagent consumption to a few microliters, overcoming the error issues associated with microfabricated fluidic channels.

The team developed and deployed the LC-MS and LC integrated µSI process analyser systems for online multi-attribute method (MAM) assay and glycan measurements. They also created a turn-key A2P2 system to expedite the development of attribute-centric biotherapeutic manufacturing processes.

Key design considerations for the autonomous PAT platforms were reducing instrument footprint, faster result turnaround, software-driven features, capability consolidation, and simplified operation. The platforms contain fluidic conduits and strategically placed material handling mechanisms to conserve resources, optimise assay efficiency, maintain controlled conditions, produce reproducible results, and ensure long-term system robustness.

The systems consist of multiple functional unit operations working together through programmable algorithms to manage sample and reagent logistics, direct processes, and reactions. They enable self-directed assay protocol selection with rule-based parameter adjustment for optimal output, thereby informing process development through the ability to execute complex assays rapidly.

The proposed autonomous PAT platforms can be easily integrated into a strategy that enables real-time, attribute-focused process development, monitoring, and control in the biopharmaceutical industry. The integration of fluidic miniaturisation, autonomous diagnostics, and advanced analytics yields substantial efficiency gains and ensures the efficient development of processes that consistently produce high-quality products.