Phorum

Drug Substance

Deliverables

Sep 2019

Drug Substance

Creating a lean approach to qualification and validation

The Lean Qualification and Validation (LQV) workstream has published the first in a proposed series of practical guides to support the wider[..]

Read article

Jul 2019

Drug Substance

Best practice on transport qualification: good distribution practice

Transport validations “were like building a new Eiffel Tower every time,” said Kim Bang Salling, Transport Validation Expert at Novo Nordisk. “The documentation[..]

Read article

Jun 2019

Change Notification

Decision tree to support alignment of risk assessment for changes to single-use biomanufacturing systems

The BioPhorum single use change notification team has been working on developing and standardizing best practice for single use change notification since[..]

Read article

Mar 2019

Drug Substance Papers

General recommendations for harmonization of local regulations for post-approval submissions with WHO and ICH guidelines, example of Brazil

This concept paper outlines BioPhorum’s considerations regarding Anvisa’s intention to adopt WHO guidelines while meeting the related ICH ones. The paper demonstrates[..]

Read article

Nov 2018

Continued Process Verification News

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[..]

Read article

Oct 2018

Drug Substance Papers

Guide to implementing and maintaining a leader observation and coaching program

Read article

Sep 2018

Change Notification Tools

A guide to the classification of changes to single use biomanufacturing systems

Read article

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
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
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
Sharing powerful collaboration data on the impact of resin cycling on viral clearance

A crucial issue for biotechnology products is that the mammalian cell lines commonly used in manufacturing are susceptible to viral contamination. Therefore, demonstration of viral[...]

Read More
Industry bioassay approach helps to shape the future

In 2018, members of the Development Group Bioassay workstream came together to write a best practices paper on bioassay development. We are delighted to announce[...]

Read More
Sharing ideas on forced degradation

“Forced degradation studies are an important part of the drug lifecycle process as they can inform many aspects of drug development,” said Jennifer Halley, Principal[...]

Read More
Delivering globally on in-line monitoring and real-time release

BioPhorum is increasing its focus on delivering against strategic goals of member companies as outlined in the BioPhorum Biomanufacturing Technology Roadmap. The first step in[...]

Read More
New and improved User Requirements Toolkit for single-use systems

To help customers and manufacturers achieve a ‘right first time’ implementation of single-use systems, BioPhorum launched a User Requirements Toolkit in June 2018. This includes[...]

Read More
Why raw materials are the unsung heroes of human medicinal product manufacturing

“It’s not easy being a biopharmaceutical raw material…” So says Kara Stockett Quinn of Merck & Co. In a recent American Pharmaceutical Review article, Quinn[...]

Read More
PUPSIT – An update on BioPhorum/PDA work to develop a risk-based position
Read More
Driving the evolution of secondary packaging

How do we transition from large-batch manufacture to small-batch, high-value packaging runs?

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
Logistics collaboration hub: An opportunity for significant time and cost savings

Most biopharmaceutical manufacturers use a network of logistics service providers (LSPs) to deliver warehousing, transport and distribution services, and they are usually linked using customized,[...]

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
BioPhorum’s Maturity Assessment Tool gains momentum
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
Delivering globally on in-line monitoring and real-time release

BioPhorum is increasing its focus on delivering against strategic goals of member companies as outlined in the BioPhorum Biomanufacturing Technology Roadmap. The first step in[...]

Read More
Removing the roadblocks to continuous biomanufacturing

Continuous downstream processing is increasingly seen as a feasible approach for manufacturing biologics. The industry recognises that it offers advantages over batch-based processing by:

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
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
Regulatory compliance: what lessons can be learned?

BioPhorum delivery of value from the disposables five-year plan - supplier change notifications for single-use systems

Read More
Navigating the maze of medical technology regulation: a solo voyage or a team effort?

Medical technology is a global business, generating annual revenues of over $400bn. The sector encompasses a broad range of technologies: from in-vitro diagnostics and diagnostic[...]

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
Changes to BioPhorum extractables protocol

The BioPhorum Extractables team has shown the benefits of great collaboration between biomanufacturers and suppliers – they agreed to significantly reduce extractables testing for single use[...]

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 and improved User Requirements Toolkit for single-use systems

To help customers and manufacturers achieve a ‘right first time’ implementation of single-use systems, BioPhorum launched a User Requirements Toolkit in June 2018. This includes[...]

Read More
What is BioPhorum and how does it work
Read More
Overview of the BioPhorum Technology Roadmap
Read More
Japan’s bioeconomy strategy objectives and principles
Read More