Contamination Event Free Production Process by 2022

Contamination Event Free Production Process by 2022

For three years the microbial team has worked to address significant challenges in the areas of quality, risk, and cost – all with positive results. But satisfying operational issues was only delivering success on one level. Through recognizing the strategic needs of the member companies, a more significant objective emerged: achieving an industry-wide contamination free production process.

Informed by the members’ strategic goals and the Technology Roadmap plan, the team was able to describe a compelling purpose and a realistic plan to ultimately eliminate microbial contamination issues in the production process within five years.

 

A meeting held recently provided the opportunity to refine and agree the way forward:

“This meeting converges the vision and action for the optimal microbial control strategy for those who are concerned with and involved in managing microbial contamination risks in biopharmaceutical manufacturing,” said Ren-Yo Forng, Amgen.

The vision

To develop best practices, provide guidance and drive consistent application of effective and efficient microbial control strategies for manufacturers of low bioburden bulk biologics in order within five years to:

>bring all sites to the contamination prevention performance level of the best

>support the Technology Roadmap ambition for new product launches

>demonstrate complete mastery of Microbial Control and gain regulatory support for Microbial Control strategy.

While ambitious, the vision and plan can be achieved by collaborating with members to leverage the operational, technical and cultural elements that exist in pockets across the industry. This plays to the strength of the BPOG collaboration – when members come together to share their individual practices and create a whole that is greater than the sum of the parts.

Creating and delivering a compelling strategy and implementation plan for microbial control will address critical operational issues such as the reliability of automated laboratory equipment, enable the successful delivery of the Technology and achieve complete mastery of microbial control.

 

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