This presentation given by two MediPhorum subject matter experts at the Pre-filled Syringes east coast conference in April outlines the team’s findings on combination product essential performance requirements (EPR’s) interpretation and control strategy development
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Human Factors industry opinion survey: ​US submissions for drug delivery devices
Apr 2023 | Conference, Deliverables Report, Drug Delivery, MediPhorum
MediPhorum Human Factors group recently presented  at the Human Factors and Ergonomics Symposium in Orlando USA on 26th March 2023 the results of a survey seeking global insights towards harmonizing best practices in human factors study design and FDA submissions across industry, predominately related to biomanufacturers combination products.
Cell and gene therapy critical starting material –establishing release specifications for plasmids
Oct 2022 | Cell & Gene Therapy, Conference, Deliverable, Deliverables Report, Raw Materials Sourcing
A BioPhorum member only deliverable describing the work of the Plasmids subteam
Industry approaches for implementation of ready to use ( RtU ) cells in bioassays
Oct 2022 | Bioassay, Conference, Deliverable, Deliverables Report, Development Group, POI - Development Group
This poster recently presented at CASSS Bioassay and BEPA describes selected results of an industry collaboration to encourage discussion on common approaches to ready to use (RtU) for bioassays cell manufacturing, testing and implementation across the industry.
Viral Clearance worst-case conditions presentation at PDA Viral Clearance conference
Jun 2022 | Conference, Deliverable, Deliverables Report, Development Group, Viral Clearance
This member only resource developed by the BioPhorum Development Group Viral Clearance team is based on their analysis of the worst-case conditions benchmarking survey and was presented at the PDA Viral Clearance conference in Brussels in June 2022.Â
Host cell protein risk assessment- Where we are with BioPhorum cross-company collaboration and what we have learnt from an industry perspective?
May 2022 | Conference, Deliverable, Deliverables Report, Development Group, Host Cell Proteins and other Bioresidual Impurities
A presentation on cross-company collaborative work and learnings produced from an industry perspective on host cell protein risk assessment. The presentation included a history of the HCP workstream, previous publications, planned future work and publication plans.
Viral Clearance worst-case conditions presentation
Oct 2021 | Conference, Development Group, Viral Clearance
Poster presentation at BPI East based on analysis of the Viral Clearance worst-case conditions benchmarking survey.
NIIMBL-BioPhorum BSB System – Buffer preparation of the future – presentation notes
Oct 2021 | Buffer Preparation, Conference, Deliverables Report, Technology Strategy
Presentation by Jeff Johnson on behalf of the NIIMBL-BioPhorum BSB System Team at BPI East September 2020
NIIMBL-BioPhorum Buffer Stock Blending System – Presentation notes
Oct 2021 | Buffer Preparation, Conference, Deliverables Report, POI - Technology Strategy, Technology Strategy
ISPE virtual seminar NIIMBL-BioPhorum Buffer Stock Blending System presentation
Oct 2021 | Buffer Preparation, Conference, POI - Technology Strategy, Technology Strategy
This presentation, presented to ISPE Young Professionals, provides an overview of the NIIMBL BioPhorum buffer stock blending system. This will be capable of supplying, in an automated manner, all buffers required for typical purification processes at a quality that is acceptable and equivalent to traditional batch buffer preparation. He also gives an insight into the economic benefits of the technology adoption for both intermediate and large scale manufacturing facilities.