This paper uses a standardized, modular design and construction approach the benefits of a modular design approach to a multi-product viral vector (VV) facility at late-clinical/early-commercial scale, showing how significant speed benefits can be gained at each stage of facility design, procurement, construction, qualification and operation.
Document designed to support the design of a checklist for technology readiness in an end-user company technology implementation program.
The pdf is a fully navigable high-level toolbox and guidance for R&D, technology discovery, sponsors, risk managers and regulatory teams.
Presentation by Jeff Johnson on behalf of the NIIMBL-BioPhorum BSB System Team at BPI East September 2020
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.
BioPhorum Technology Roadmapping roadmap vision 2.0 looks back on the last five years of the roadmap journey, reflects on how far we have come, and repositions the phorum vision and objectives for the next ten-year phase. The vision and supporting commentary communicate the high-level business drivers that underpin the map: patients, products, the pace of change, and performance. It also covers the scenarios and industry capabilities that will be required to meet these challenges, described as outcomes rather than solutions. Our mission is to create one voice for the biomanufacturing industry to articulate solutions and accelerate their adoption.
This document is one of a series, written to address the problems associated with automating equipment that lacks interoperability in the biopharmaceutical industry. It relates to the BioPhorum Stirred Tank Unit Interface Specification referenced in Appendix A, which was the first of its kind and as such, contains a number of introductory sections describing the principles upon which it, and an accompanying series of documents, are based. In turn, these principles relate back to the established standards of S88, S95 and OPC-UA, and the developing ‘plug-and-play’ approach of NAMUR (User Association of Automation Technology in Process Industries), with its module type package (MTP) equipment definition.
The Plug-and-play computerized systems validation strategy is a guidance document aimed at maximizing the benefits of adopting the BioPhorum approach to interoperable, modular equipment assemblies (commonly referred to as ‘skids’). The approach is based on NAMUR´s Module Type Package (MTP) standard1
and a series of interface specifications which the BioPhorum Plug and Play team is creating.