UK Biomanufacturing Team to Lead Development of Automated Controls

A UK-based consortium consisting of BiologIC Technologies, Biopharm Services, CPI, Pall Corporation, and SCIEX has announced the start of a project dedicated to developing automated manufacturing controls for use in biologics production. Innovate UK has supported the project, which is equivalent to the cost of £3.1 million, including equipment contributions, in order to platform the sophisticated technology.

Accelerating Continuous Manufacturing of Drugs and Vaccines

While the rapid development and scale-up of COVID-19 vaccines has demonstrated what can be accomplished through biopharmaceutical manufacturing, it has also emphasized the necessity to develop and manufacture revolutionary medicines and treatments at scale in a timely and reliable manner.

By improving flexibility and sustainability, minimizing batch failures, and opening the path for real-time product delivery of biopharmaceutical medicines, this project intends to address some of the production problems encountered in the pharmaceutical sector. This aims to cut NHS expenses by decreasing manufacturing costs and improving product quality, while also boosting access to life-changing drugs.

The Project is focused on the Production of Monoclonal Antibodies

The project concentrates on the production of monoclonal antibodies (mAbs), but it is built in such a way that it may be used for other forms of therapy, such as vaccinations and viral vectors. The collaboration will create a prototype advanced control strategy that is independent of equipment or control system providers, and then apply it to a small-scale continuous bioprocessing module that is running at CPI. Pall Corporation and SCIEX have provided equipment and process technologies to this partnership, while CPI specialists will develop and execute the automation system.

BiologIC Technologies will use its industry 4.0 full-stack technology platform to create a smart fluidic system with integrated inline sensors that will allow uninterrupted flow between unit operations. Biopharm Services’ lead partner BioSolve Process cost modeling platform will be connected to the continuous bioprocessing module.BioSolve is used to evaluate biopharmaceutical product manufacturability while optimizing the continuous bioprocess as assessed by cost of goods, facility throughput, scalability, and environmental sustainability.

Andrew Sinclair, President of Biopharm Services, said:

“The automation and control strategy principles developed in this project are not only amenable to traditional biopharmaceuticals but can also be applied to the next generation of virus-based vaccines, mRNA vaccines, gene therapy treatments and targeted biotherapeutics. By clarifying the business case using BioSolve Process and actively sharing practical control strategies, the consortium will advance UK biopharmaceutical manufacturing.”

Richard Vellacott, CEO of BiologIC Technologies commented:

“As pioneers in next generation bioprocessing, we are delighted to collaborate with world class partners to significantly intensify the continuous manufacturing of therapies and make them more accessible to the patients that need them.”

Harvey Branton, Technology Lead – Biologics, CPI, stated:

“The automated control of biologics manufacturing needs to transition from proof of concept to implementation in UK facilities; this project will incorporate new process analytical tools that can be actively promoted by consortium partners.”

Mani Krishnan, Vice President of CE & Biopharma at SCIEX, said:

“We provide precision analytics and confident answers to empower our customers to make the right decisions and accelerate biopharma development. It is an honour to continue partnering with this consortium. In-line and at-line process analytics reduce waste and increase process robustness. This allows our customers to shorten development timelines and bring affordable high-quality biopharmaceuticals to patients.”

Ed Hoare, General Manager of Pall Corporation’s biotech division, added:

“Pall is committed to supporting the development of faster, safer and more economic manufacturing processes and to continue to overcome the challenges of the industrialization of these rapidly growing therapies and vaccines. We are proud to be part of this consortium and to remain at the forefront of the evolution of bioprocessing.”

About CPI

CPI works with partners to translate inventions into products and processes that enhance health and wellbeing, protect and improve our environment and increase productivity across industries.

With a deep understanding of technology fore-sighting, innovation processes and funding, outstanding technical expertise and industry-relevant assets, CPI enable the accelerated development of transformational products and processes that have the potential to disrupt and revolutionise markets.

CPI also engages in incremental technological innovation that allows established products and processes to be optimised for better performance and efficient manufacture.

Through the breadth of its technology platforms, CPI supports its partners across many diverse markets, including pharmaceuticals, specialty chemicals, food and drink, electronics and transportation.

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About Pall Corporation

Pall Corporation is a filtration, separation and purification leader providing solutions to meet the critical fluid management needs of customers across the broad spectrum of life sciences and industry. Pall works with customers to advance health, safety and environmentally responsible technologies. The Company’s engineered products enable process and product innovation and minimize emissions and waste. Pall Corporation serves customers worldwide.

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