NEWS

A tangible guide to design and implement continuous manufacturing

16 June 2023
Technology Strategy
Graeme Moody
Program Manager

Cost-effective, rapid, and flexible biopharmaceutical production is an industry-wide challenge. Process intensification through continuous manufacturing has proved successful in other industries and is a promising area of investigation for researchers, vendors, and biomanufacturers.

Moving beyond batch operation, linking process steps together and interdependence between the two require new and more complicated control strategies, and is one of the business and technical barriers that have hindered the widespread adoption of continuous bioprocessing.

This means industry urgently needs to rationalize and simplify the product handoff between unit operations – and that is why we have published Continuous bioprocessing control and connectivity.

Our paper reduces the product handoff between one unit operation and the next to just three possible control schemes, which considerably simplifies the description of connections between process steps.

“While continuous biopharmaceutical manufacturing meets the pressing need for cost-effective, responsive manufacturing solutions that adapt to fluctuating market demand, implementation is often hindered by the perceived complexity of the operations,” said Ashley Reeder, Investigator at GSK. “By distilling the control scheme down to its fundamental components, this paper provides a tangible guide for teams seeking to design and implement continuous manufacturing environments.”

Simplicity is key

Starting with an example mAb platform process, we identified 22 discrete connections, which were rationalized to 16 possible combinations based on the nature of the volumetric mass flow out of a unit operation and the volumetric mass flow into the subsequent operation. With just three control schemes relevant for the interconnection of process steps, interconnections can become conceptually and physically modular.

This is important as it drives simplicity in building the process and creates the possibility of having a standard set of valving, surge tanks, and process analytical technology employed for each control scheme. This simplifies the number of skids that must be ordered and may help reduce the inventory required to handle deviations or process failures. Also, using the same interconnection strategy between multiple operations simplifies the control strategy, as the same one can be used between all connections that use the same scheme.

Kristina Pleitt, Senior Manager at Thermo Fisher Scientific, said, “Although operationally beneficial, increasing automation and eliminating downtime between unit operations can feel like a risky, complicated aspect of continuous bioprocessing (especially for those more removed from development and implementation). Here we show how focusing on a few fundamentals and following a simple, systematic exercise makes the process control concept and strategy approachable to even those who are newer to integrated, continuous bioprocessing.”

If you are a bioprocess engineer, work in process control, or are an automation engineer who designs and implements continuous processes for manufacturing biotherapeutic molecules, then this paper is for you. It will also be useful for technical leaders in biomanufacturing and contract organizations considering implementing continuous processing capabilities.

For more information, download the paper here and contact Graeme Moody, Program Manager, at graeme.moody@biophorum.com

Infinity Sign On Dark Background
NEWS
Bringing BioPhorum’s unique perspective to continuous manufacturing in biologics

Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

Development Group

Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

Drug Substance

Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

Fill Finish

Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

Information Technology

Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.

Quality

BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.

Regulatory-CMC

Regulatory CMC brings leaders together who have a common goal – to improve access to medicines through innovation in the Regulatory ecosystem. It provides a dedicated space for strategic leadership and a coordinated industry voice, to move from divergence to convergence.

Supply Chain to Patient

Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

Supply Partner

Supply Partner is a trusted advisory group and collaboration that is the engine for driving change across the global industry for all things relevant to the inbound supply chain. Addressing the challenges of complexity, resilience, cost, sustainability, and innovation.

Sustainability

Sustainability enables the industry’s transition to a low carbon, circular future – supporting members to improve patient health while respecting the planet. We activate multi-disciplinary teams drawn from our network to deliver environmental sustainability improvements across the value chain.

Technology Strategy

Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

DOWNLOAD
An industry perspective on understanding AAV capsid content variants
Needle On Yellow Background
EXTERNAL-RESOURCE
An intercompany perspective on practical experiences of predicting, optimizing and analyzing high concentration biologic therapeutic formulations
DOWNLOAD
The Drug Substance 2.0 Strategic Value Framework
Coloured dots on teal, next to vial
DOWNLOAD
BioPhorum’s holistic approach to container closure integrity
Magnifying glass over a tablet all coloured blue
DOWNLOAD
Digital Plant Maturity Model 3.0
Investigation Digital Workstreams
DOWNLOAD
Peer to peer practical guidance on remote inspections and audits
PODCAST
The next step in building regulatory as a capability to enable strategic innovation across the BioPhorum community
BioPhorum roundals on sugical gloves
DOWNLOAD
A visionary strategic framework for future patient-centric outbound biopharmaceutical supply chains
DNA and Earth on blue background
DOWNLOAD
A vision for the biopharmaceutical industry’s inbound supply chain
Lightbulb And Icons On Colourful Background
DOWNLOAD
BioPhorum environmental sustainability roadmap 2022
Technology Roadmap V 2.0
DOWNLOAD
BioPhorum Technology Roadmapping roadmap vision 2.0

Publications

Documents including best practices, vision statements and peer reviewed papers to help you take value back to your business.

Webinars

Discussing all aspects of the biopharmaceutical industry, from digitization and knowledge management to raw materials, supply chain, sustainability and more. Learn from the perspectives of those at the forefront of the industry.

Podcasts

BioPhorum Connect is our podcast series that keeps you up to date with the latest news and trends in the biopharmaceutical industry. From experienced professionals to thought leaders, these podcasts bring you the insights and perspectives of experts from around the world.

Tools

A variety of resources including design tools and user requirement specifications to help you improve and streamline your business processes.

Benchmarks and Surveys

Research conducted among the BioPhorum membership providing evidence to support change and identify best practice.

Browse all

Access a variety of free tools and papers and other resources designed to provide you with up-to-date information and insights to help you make informed decisions and maximize your success. Access our resources today and start making improving and streamlining your business processes.

WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
Magnifying glass over a tablet all coloured blue
DOWNLOAD
Digital Plant Maturity Model 3.0
WEBINAR
Bioreactivity testing in single-use system biomanufacturing