The topic of campaign manufacture for lyophilization processes was discussed by the BioPhorum Lyophilization group. This member only publication is a summary of the approach taken by the major biopharmaceutical companies with experience of campaign manufacture who are members of the group.
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This document describes the basis for performing a risk assessment for line clearance (LC) activities and failures. It contains a general description about the process and a template. This template is meant to support the documentation of the assessment of risks related to the LC process in secondary packaging lines handling pharmaceutical products and combination devices.
A systematic approach for the evaluation, validation, and implementation of automated colony counting systems
This paper describes a systematic approach to the evaluation, equipment qualification, and deployment of automated colony counting systems, which can be applied by biopharmaceutical companies wanting to take advantage of the numerous benefits.
Standardized methodology to support particle investigations and classification in biopharmaceutical parenteral products
This paper provides a framework to support investigations related to atypical or frequently occurring particles observed during VI or related to field complaints – which require detailed and systematic assessment of risk to the quality of the batch. The proposal for a standardized risk investigation methodology outlined in this paper may support such risk assessments, where the total risk related to foreign particles is assessed by considering a variety of risk factors (type, frequency, etc.) and applying a failure mode and effects analysis (FMEA) tool to calculate a total risk-based score.
A member only benchmark examining the technology trends in visual inspection.
A BioPhorum member only attribute matrix consisting of analysis of the current and desired state of PAT for ILM/RTR
A BioPhorum member only benchmark survey identifying line clearance best practice, as part of the Secondary Packaging workstream.
This paper delivers a seminal example of how BioPhorum can partner with biopharmaceutical suppliers to address the needs of the industry, support new technology adoption in biopharma and facilitate positive and lasting change. BioPhorum’s Small Flexible Filler (SFF) URS allowed Groninger to build a line that would otherwise not exist, defining a strategic direction for the future of liquid fill and finish for the biopharmaceutical industry. Within two and a half years of BioPhorum publishing the SFF URS, Groninger, a German supplier to the industry, has developed a gloveless, robot-based, automated filling line that aligns with the URS and relevant current regulatory expectations.
Slide Deck – A Standardized Risk Assessment Tool and Harmonized Approach for Selection and Definition of Environmental Monitoring points
The slides that support the webinar presentation ‘An industry perspective on common practise in forced degradation studies of biopharmaceuticals’, presented on 15 June 2021.