Continuous 2 is an active project aiming to address the growing demand for cost-effective biologics treatments. With the global biopharmaceutical market estimated to grow to 3.9bn by 2024, the industry must act quickly to make these life-changing drugs more accessible to patients, and respond to the demand for flexible manufacturing technology that delivers real-time release of biotherapeutics.

UK Continuous 2 is building on the achievements of two previous projects:

UK Integrated Continuous Bioprocessing project 2020: this project established an integrated continuous downstream manufacturing platform for monoclonal antibodies;
The Digital Integrated Intelligent Continuous Biomanufacturing project 2021: this project developed the system further by integrating predictive models and maintenance on selected unit operations, demonstrating the impact of a digital operation that could predict and mitigate failure during the production process.
The progress of these two previous projects cannot be understated, and provide a remarkable foundation of research for us to build upon; the aim of UK Continuous 2 is to build a proof-of-concept process that releases biotherapeutics in real-time.

Biologics effectiveness and popularity are rising, and now used as therapy to treat a large number of debilitating diseases. However, many life-changing drugs currently remain undeveloped because of the risks and costs associated with production. To ensure safety and efficacy, current manufacturing processes include extensive end-to-end quality testing which can take up to six weeks.

Continuous and integrated biologics manufacturing processes have the potential to address this challenge, allowing drugs manufacturers to become more agile in response to demand – and make lifechanging drugs more cost-effective and rapidly available to patients.

Integrated manufacturing, with improved process control and real-time data-analytics, generates more robust, stable processes in a shorter time. This is referred to as ​“speed-to-clinic”, removing process development from the critical path to clinical results.

To date, we have:

- Designed, installed and operated a second-generation continuous manufacturing system with upstream perfusion capability. The continuous system offers a flexible, modular, and license-free platform with a range of a processing diversity

- Established critical quality attributes (CQAs) to monitor, using novel in-line and at-line process analytical tools (PAT)

- In collaboration with Sciex, expedited CQA analysis using the Mass Spec, and reduced analysis time to 30 minutes from 8 hours

- Established BiologIC Technologies base Biocomputer architecture, a core component of their technology and future advancements

- Integrated Biopharm services software to enable facility and process optimisation to support the cost-effective manufacture of therapeutics

Our end-vision is of a continuous production platform that supports real-time release of bio-therapeutics.

The mission of UK Continuous 2 is to get closer to developing a proof-of-concept that demonstrates real-time release. So far, we’ve reduced analysis timescales from hours to minutes, getting much closer to this goal.

The next steps before October will focus on a number of continuous process runs generating sufficient data, to develop and build advanced process control models to control key CQAs and critical process parameters (CPPs).

The potential impact of continuous manufacturing systems for biologics offering real-time release is wide-reaching.

Economically, decreasing process development time has been shown to save drug development costs of $10sM2. This would help the industry become more efficient in using its resources, ultimately saving time and money to spend on other areas in the industry. With greater process knowledge, the project could also improve quality and safety of biologics

Minimising the time to batch release will also rapidly reduce the cost of biologics, making affordable, life-changing therapies available to the NHS. In turn, people would have greater access to these drugs – an impact that is hard to comprehend on an individual level. Societally, making treatments widely available to people across the UK and beyond, no matter their background, would be an incredible mark of progress for the industry.

The impact of real-time release of biotherapeutics thorough continuous manufacturing systems is not to be underestimated; for the industry, for the NHS, and for indviduals.

With several months left of the project, we’re excited for the conclusion in October 2023, watch this space. You can read about the UK Continuous 2 project in more detail in the American Pharmaceutical Review at https://www.americanpharmaceuticalreview.com/Featured-Articles/589065-I…

Full case study: https://www.uk-cpi.com/uk-continuous-2