Additional challenges to the new cleanroom paradigm from concurrent multiproduct manufacturing of bulk drug substances in a controlled non-classified (CNC) ballroom environment.

May 1, 2013
By:Simon Chalk,Scott Probst,Ken Green,Russell Moser,Frank Urbanski,Matthew Zicaro,Paul Smock,Larry Pranzo,Liz Dooley,Phil McDuff
BioPharm International
pp. 38-47

The existing model of locating biopharmaceutical manufacturing in classified cleanrooms is being re-examined as the biopharmaceutical industry aims to improve patients’ access to products by reducing costs, while maintaining assurance of product quality and patient safety. The evolution of verifiably closed-manufacturing technologies is replacing open systems, thus removing the need for the extensive use of costly, classified environments as a risk-mitigation measure. By putting technical and procedural advances together with scientific and quality risk-based approaches, many industry leaders are improving process equipment systems such that reduced area classifications (grade D/ISO 8 at rest) and controlled non-classified (CNC) environments are now deemed appropriate for functionally closed systems and closed bulk drug-substance bioprocesses. The approach is one step towards helping reduce capital and operating costs, and thus product cost, which is a factor in improving patient access.

Another facility design and operational approach that may be attractive to industry is that of drug substance (DS) bioprocess manufacture in a “ballroom” facility. A ballroom-style facility utilizing closed systems might, in some situations, be the most economically attractive facility design, allowing for faster construction and more efficient use of financial resources and operating labor, contributing to overall lower product cost. <

This article follows on from a previous publication (1) in which the authors discussed the trend towards manufacturing bulk-drug substances in areas of lower classification for a dedicated single-product facility (1). The authors suggested potential risk-mitigation approaches to protect product quality and minimize operator safety risks, and also provided estimates of the capital and operating cost benefits. This article considers the potential additional risks that concurrent multi-product manufacturing in a common/shared ballroom facility introduces. The premise is that the concepts discussed in the prior publication and extensive use of closed processing in a CNC environmental are successfully applied. It also seeks to meet industry regulations for formal risk-management approaches (QRM) (2) to the design of facilities, especially because the updated EU Annex 2 mentions risk early on and extensively (2).

The focus of this paper envisages typical combinations of biological product classes within the same CNC ballroom facility. The industry may be ready for multiproduct processing in a facility design that is radically different from those found in use today. Certain product classes, product properties, or host systems may still require dedicated facilities or specialized containment equipment to minimize the risk of operator exposure or cross-contamination.

For industry participants to have a meaningful dialogue around these concepts globally understood and accepted definitions need to be established. The authors are grateful to the leaders of initiatives within ASME BPE, and ISPE, which are creating definitions that will be adopted by the pharmaceutical industry. Draft wording from this work is included in the online extended version of this article found on https://www.biopharminternational.com/biopharm/Feature+Rotating+Article/New-Challenges-to-the-Cleanroom-Paradigm-for-Multi/ArticleStandard/Article/detail/813380

Contact address

BioPhorum
The Gridiron Building
One Pancras Square
London
N1C 4AG

Newsletter subscribe

You can unsubscribe at any time by clicking the link in the footer of our emails. For information about our privacy practices, please visit our website.



© 2019 Biophorum Operations Group · All Rights Reserved

Registered Address: 5 Westbrook Court · 2 Sharrow Vale Road · Sheffield · S11 8YZ

Company Number 06794795 · VAT Number GB298617544

Driving progress in Cell & Gene Therapy

Now with 19 member companies and 183 subject matter experts, the BioPhorum Cell & Gene Therapy (C>) Phorum has made great strides since its formation[...]

Read More
Join BioPhorum at BioProcess International events

We have partnered with BioProcess International for more than five years. In that time, their conferences have provided platforms to socialize the collaboration’s key new[...]

Read More
Cell and Gene Therapy Phorum accelerates progress

The BioPhorum Cell & Gene Therapy Phorum has made significant progress since its creation in 2018 – from building networks and sharing knowledge to endorsing[...]

Read More
The BioPhorum and USP collaborative journey to new standards

BioPhorum and United States Pharmacopeia (USP) share a common direction – to accelerate biopharma innovation, quality and progress through collaboration.

Read More
Perfecting balanced scorecards for CDMOs

Established in March 2017, the Development Group’s Development Outsourcing effort aims to share and build guidance that will help companies make the best decisions and[...]

Read More
Formulation team drive for more value

Since its start in 2013, the Formulation Point Share has been busy. Its latest article, An inter-company perspective on biopharmaceutical drug product robustness studies, was[...]

Read More
Join BioPhorum at BioProcess International events

We have partnered with BioProcess International for more than five years. In that time, their conferences have provided platforms to socialize the collaboration’s key new[...]

Read More
2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you to work on[...]

Read More
Why leaders should go to where work is performed to learn about success, failure and risk
Read More
Hi-tech ambitions for Fill Finish

The Fill Finish Phorum has recently embarked on a series of exciting and ambitious initiatives, exploring new technologies and processes to enhance the efficiency and[...]

Read More
Companies poised to follow ARMM recommendations

The Advanced and Rapid Microbial Methods (ARMM) team set out a clear case for modernizing Environmental Monitoring (EM) in grade A settings: in summary bio-fluorescent[...]

Read More
How to achieve the ‘Goldilocks’ amount of environmental monitoring

Regulators require a risk-based approach to environmental monitoring (EM)… but they give no clear definition of what “risk-based” actually means. The aim of the Environmental[...]

Read More
The ‘how to’ guide to implementing Agile in GxP

The publication of the Guidance on the use of Agile in a GxP Environment document in 2017 was well received.It described how the use of[...]

Read More
How smart is your maintenance?

Faster. Cheaper. Smarter. All companies are under pressure to achieve more with less, not least with their maintenance programs. But while ‘faster’ and ‘cheaper’ maintenance[...]

Read More
2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you to work on[...]

Read More
Join BioPhorum at BioProcess International events

We have partnered with BioProcess International for more than five years. In that time, their conferences have provided platforms to socialize the collaboration’s key new[...]

Read More
Supply chain, forecasting and demand planning solutions gain momentum

The relationship between suppliers and manufacturers is one of the most crucial in biopharmaceutical manufacturing. This is especially the case when forecasting and supply planning.[...]

Read More
2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you to work on[...]

Read More
Changing mindsets with a modular approach

Historically, manufacturers have used a ‘waterfall’ approach when designing and building their production facilities, sequentially resolving and specifying all aspects up front and in detail[...]

Read More
Join BioPhorum at BioProcess International events

We have partnered with BioProcess International for more than five years. In that time, their conferences have provided platforms to socialize the collaboration’s key new[...]

Read More
How do you bring technology roadmapping to life?

You use it to make change happen and that is exactly what the Phorum’s leaders did after the first edition of the Biomanufacturing Technology Roadmaps[...]

Read More
Slicing years off change implementation

As the first regulatory authority in Latin America to gain full membership of the International Council for Harmonization (ICH), the Brazilian Health Regulatory Agency (Anvisa)[...]

Read More
BioPhorum Regulatory Interaction: helping to open doors

To implement any change in the biopharmaceutical manufacturing industry it is important to engage with and collaborate with the regulators. Set up two years ago,[...]

Read More

IaaS Cloud webinar recording play back
Read More
New BPIT guidance to align cloud services to regulatory requirements
Read More
Data Integrity and Agile Webinars to support industry response to regulators
Read More
How to validate informatics in CPV programs

The BioPhorum Continued Process Verification (CPV) and Informatics team has published a paper to support a risk-based approach for the validation of informatics systems for[...]

Read More
Continued Process Verification delivering real saving in time and money

More than 50 per cent of biopharma products on the market now have Continued Process Verification (CPV) plans in place.  Thanks to the CPV white[...]

Read More
A roadmap for the implementation of continued process verification

This article provides a roadmap draws on the content of the CPV case study to provide a step-by-step guide in a more accessible form.

Read More
How smart is your maintenance?

Faster. Cheaper. Smarter. All companies are under pressure to achieve more with less, not least with their maintenance programs. But while ‘faster’ and ‘cheaper’ maintenance[...]

Read More
Digital plant maturity model webinar replay
Read More
Digital Plant Maturity Model workstream to host webinar
Read More
New guidance available on Forecasting and Demand Planning to streamline supply chain performance
Read More
Host cell proteins poster

This poster presented at the BEBPA Conference, San Francisco builds and consolidates the information currently available in the industry for assessing process risk from Host[...]

Read More
Host cell protein risk assessment, an industry approach

Host cell protein (HCP) constitutes a significant class of process-related impurities in biological drugs.

Read More
BEBPA risk assessment workshop
Read More
New toolkit to accelerate single-use design and specification

The single-use user requirements toolkit is now live and available for free download on the BioPhorum website  The toolkit streamlines the design and specification process[...]

Read More