Closed systems in controlled none classified (CNC) space

This workstream supports the low bioburden biologic drug substance manufacturing industry to adopt closed-system technology and build facilities which use lower classification cleanrooms, ideally CNC space.

Over-engineered solutions utilized

Traditional and over interpretation of regulatory requirements for Closed Systems has led to over engineering of cleanroom infrastructure. This ultimately results in higher costs and slower speed of introduction of new drugs to patients. Each increase in classification adds 25% increase in cost. Moving to CNC and fully utilizing the benefit could save up to 50% of your CAPEX and OPEX costs as well as more flexible equipment utilization.

Driving industry and regulatory acceptance

Closed systems enable multi-product multi-platform facilities, speeding up process development by adoption of standardization. The goal of the team is to drive industry and regulatory acceptance of closed-process manufacturing and the elimination of unnecessary cleanrooms. This will create clear regulatory requirements and the highest possible product quality. It allows simplification of processes and facilities and best value manufacturing.

Closed systems in controlled none classified (CNC) space deliverables


Closed systems: How much harm can a single droplet do? Considerations for a viral inactivation step

9 January, 2024Link

Closure Playbook—glossary of key terms, abbreviations and acronyms

9 January, 2024
369.91 KB

Chapter 2: Closure Playbook – regulatory considerations

9 January, 2024
461.95 KB

A risk-based approach to filter integrity testing requirements for biologics drug substance manufacturers

25 September, 2023
1.09 MB

Closure Playbook – introduction

21 September, 2023
402.14 KB

Closed-systems: Risk-based selection of environmental classifications for biopharmaceutical operations

12 August, 2021Link

Shared clean-in-place systems: to share or not to share

20 July, 2020Link

Closed systems: Data driven equipment and facility design case study

26 June, 2018
4.94 MB

Closed systems: Response to Annex 2

6 April, 2016Link

Closed systems: Challenging the cleanroom paradigm for biopharmaceutical manufacturing of bulk drug substance

6 April, 2011
754.41 KB

More related workstreams

Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.

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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.


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 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 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.

An industry perspective on understanding AAV capsid content variants
Needle On Yellow Background
An intercompany perspective on practical experiences of predicting, optimizing and analyzing high concentration biologic therapeutic formulations
The Drug Substance 2.0 Strategic Value Framework
Coloured dots on teal, next to vial
BioPhorum’s holistic approach to container closure integrity
Magnifying glass over a tablet all coloured blue
Digital Plant Maturity Model 3.0
Inaugural BioPhorum Quality face to face – get involved
The next step in building regulatory as a capability to enable strategic innovation across the BioPhorum community
Delivering a Cell and Gene Therapy Outbound Supply Chain Pathway for the Industry
DNA and Earth on blue background
A vision for the biopharmaceutical industry’s inbound supply chain
A major milestone – a harmonized approach to product carbon footprint data
Technology Roadmap V 2.0
BioPhorum Technology Roadmapping roadmap vision 2.0


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


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.


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.


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.

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