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BioPhorum feedback on ICH Q14 and Q2(R2)

BioPhorum feedback on ICH Q14 and Q2(R2)

Sep 2022 | , , ,

This paper is the BioPhorum response to the recent ICH Q14 and Q2(R2) consultation. Overall, the first-draft guidelines seen by the team need to be less detailed in the main body of the documents but more specific to analytical methods. The documents must also be consistent throughout (across Q14 and Q2 and between the main body texts and examples). Further, detailed examples are needed for modalities other than small molecules (e.g., biologics, cell and gene therapies, etc.) as the small molecule examples are not relevant in some key respects. In the view of the BioPhorum team, the current documents will not drive a consistent understanding of regulatory expectations and the provision of information by industry to regulators.

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Risk-based strategies to support revalidation and the assessment of requirements to maintain the validated state of equipment, process and facilities used for commercial and clinical manufacturing

Risk-based strategies to support revalidation and the assessment of requirements to maintain the validated state of equipment, process and facilities used for commercial and clinical manufacturing

Sep 2022 | , , , ,

This paper describes risk-based alternative strategies for defending the suitability of equipment and facilities requiring revalidation. These robust and risk-assessed approaches include real-time review, routine monitoring and in-/at-line alarms and measurements to help identify what data and testing are critical to assure the continued validated state of the equipment.

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White paper addendum to the NIIMBL-BioPhorum buffer stock blending system – a more advanced concept for buffer manufacturing

White paper addendum to the NIIMBL-BioPhorum buffer stock blending system – a more advanced concept for buffer manufacturing

Aug 2022 | , , , ,

This Addendum signals the release of the design and dataset from the performance testing of the NIIMBL BioPhorum buffer stock blending (BSB) system. It is being made available as ‘open source’, which the team hopes will encourage industry adoption of the BSB System. The paper provides the team’s evaluation of the testing outcomes. It also contains information relating to the methods and approach, and the lessons learned so that others can develop and improve this technology by understanding its benefits and applications.

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Challenges encountered in the implementation of bio-fluorescent particle counting systems as a routine microbial monitoring tool

Jul 2022 | , , , ,

This article published in the PDA Journal of Pharmaceutical Science and Technology discusses challenges encountered when implementing bio-fluorescent particle counting systems as a routine microbial monitoring tool , and the perspective from a consortium of four industry working groups on navigating these challenges.

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Raw materials strategy

Raw materials strategy

Jul 2022 | , , , , , ,

This document communicates a strategic framework for solving technical problems relating to managing raw materials in the biopharmaceutical industry and encourages biopharmaceutical end-users and suppliers to work together to address specific raw material and end-user process needs. It highlights the importance of implementing industry solutions and sign-posts a range BioPhorum raw materials publications. These establish standard definitions, a common understanding of raw material requirements, and the importance of regulatory, quality, and supply chain links.

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On time in full (OTIF) high level guidance

On time in full (OTIF) high level guidance

Jul 2022 | , , , ,

This paper provides an introduction and a high-level view of on time in full (OTIF) so that when we use the acronym, we know how it is calculated and are all using it in the same way. It examines detail on the components of ‘Actual orders delivered’ and ‘Expected orders to be delivered’ and talks about the information included, actions to take and gives tips on how to best use each component. 

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Lyophilizer leak rate testing – An industry survey and best practice recommendation

Jul 2022 | , , , ,

The vacuum integrity of freeze dryers is critical for attaining adequate process control and maintaining confidence in sterility assurance which is key for the manufacture of sterile pharmaceutical products. Although discussions on the topic have been published, there is no industry standard established that is based on empirical data or that has a justifiable scientific rationale. This paper published in the Journal of Pharmaceutical Sciences provides a perspective from 14 Pharmaceutical companies on the leak rate specifications commonly used in industry. Using this information the BioPhorum team recommend a best practice for the lyophilizer leak rate test.

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Digital Technology Roadmap

Digital Technology Roadmap

Jul 2022 | , , , ,

This paper outlines the foundational element that chart the course for pharmaceutical manufacturers who decide to take this journey and provides a vision of what that destination could look like in 10 years’ time. It outlines the current state of the industry, key challenges and barriers to adoption, and hints at the value that taking this journey will bring to patients, organizations and industry. This paper (which forms Part 1 of the Digital Technology Roadmap) looks at the problem statement and the work that has gone before.

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