NEWS

Using modular construction to reduce time to market and lower costs

29 June 2022
Technology Strategy
BioPhorum

It can typically take three to five years using traditional methods for a greenfield biopharmaceutical production facility to move from project inception to the completion of qualification. Being able to move faster would reduce time to market and improve business cases by reducing the time from financial outlay to income generation.

As the biopharmaceutical market expands into new modalities, manufacturers must move faster than ever to manage multiple, complex product pipelines – while handling the extraordinary demand that often strains their ability to provide capacity. As these unprecedented trends converge, innovative solutions are needed to accelerate the delivery and operation of flexible facilities that seamlessly support these modalities throughout their lifecycles. Modular design applies to all these modalities and is supremely suited to the scenario modeling and decision-making needed at the early stages of facility investment planning.

Using modular construction has been seen as a way to cut schedule by 20-50% and lower costs. But it requires a design philosophy to match. The modular design approach is a key enabler that drives the ability to take maximum advantage of modular construction and other standardizations that naturally follow.

But can this approach be applied to the fast-moving environment of new modalities in biologics? And does a modular approach work where manufacturing processes are less mature, and the modalities are inherently more multi-product?

BioPhorum thinks the answer is ‘Yes’ and has published Accelerating multi-product biopharmaceutical manufacturing facility project lifecycle through modular design.

It gives you an overview of the key concepts of modular design and contains a detailed worked example of the methodology applied to a multi-product, late-stage, clinical/early commercial viral vector facility. This shows how you can design a facility by looking at the required activities, and then identifying the repeatable elements that can be sized and designed as individual modules, before being combined into a full facility design.

A natural flow of benefits

Other benefits around risk reduction and cost efficiencies naturally flow from this approach, which increase further as modular elements are repeated in future facilities. To help you build the business case for using a modular approach, the paper also summarizes the relative benefits of an initial modular design treatment for a facility, and the benefits of working from a library of existing design blocks.

Aligning industry around a modular facility design and construction framework will facilitate a quick, agile response to a dynamic technology and regulatory space. Also, promoting the creation, maintenance, and use of libraries for modular designs at all scales and levels of standardization enables the significant reuse of facility elements across projects and ensures greater cost certainty and more rapid execution timelines.

Modular capacity to manage uncertainty

Taking the concept one stage further to modularize capacity is something that this approach can be applied to. With significant benefits to capital planning and shorter lead times between decision and operation for capacity blocks, there is more agility in the supply response to unpredictable product and portfolio demands.

The paper follows BioPhorum’s Modular and mobile: Improving the biomanufacturing facility lifecycle using a standardized, modular design and construction approach, where the benefits of a modular design approach were outlined using the example of a commercial-scale monoclonal antibody facility.

NEWS
A major milestone – a harmonized approach to product carbon footprint data
NEWS
Combination products – MediPhorum’s ‘state of the nation’ report
NEWS
Inaugural BioPhorum Quality face to face – get involved
NEWS
Forecasting the demand for single-use systems
NEWS
The new Drug Substance Strategic Value Framework – addressing industry pain points

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