The purpose of this paper is to stimulate debate in the biopharmaceutical industry and to work toward industry-wide alignment on the creation and use of optimized and lean user requirement specifications (URSs) for equipment, facilities, utilities and systems qualification.
Biopharmaceutical supply chains have evolved beyond single-source manufacturing to a complex network of collaborations and partnerships between sponsors and contract organizations. However, the expectations for deeper integration and visibility, automation and flexibility have increased and the lack of a standard framework has led to bespoke solutions which are unsustainable. This paper explains the current approaches to connecting biomanufacturing organizations, and the key benefits of improved digital integration. It articulates principles and patterns in the form of a simple maturity model that can be used to assess current state and plan for a more digitally aligned future.
This paper gives a best practice recommendation for fingerprinting cell culture media. It includes a standardized analytical test method suite, a three-tier testing approach and flowcharts that guide the reader to choose a suitable media fingerprinting method based on their goals and the raw material properties.Â
This paper summarizes the industry position and aims to start a strategic discussion on this situation. It will help ensure we have a common language and understanding across industry. Looking ahead, we will emphasize shared learning, best practices, and retrospective investigations to improve long-range planning processes
A BioPhorum member survey to gather preliminary information from across the biopharmaceutical industry on the characterization and risk assessment of HCP using mass spectrometry.
A BioPhorum member only survey to share knowledge into how, why and when enzymatic activity assays are performed.
BioPhorum member only benchmarking exercise seeking member experience on expectations for mycoplasma testing of cell therapies.
BioPhorum member benchmarking survey on testing strategies for AAV and LVV empty, full and partially filled capsids.
A BioPhorum member survey examining approaches to testing allogenic cell therapies for adventitious viral contaminants.
A BioPhorum member only survey to understand viral purification and clearance practices member companies are undertaking in CGT.