Steps to eradicate undetected contaminations in anaerobic testing
All biopharmaceutical manufacturers have a legal obligation to monitor the microorganisms that are found ...
Technology Roadmapping
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BioPhorum Technology Roadmapping roadmap vision 2.0
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.
Plug-and-Play audit trail requirements
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.
Plug-and-play computerized systems validation strategy
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.
BioPhorum deliverables mid-year report 2021
BioPhorum is here to help you make better decisions, faster in your operations. Membership puts you and your team at the center of current debates and helps you to stand shoulder to shoulder with those moving the performance dial on challenges that need a collective voice and a global perspective to resolve. The BioPhorum Deliverables Report is a consolidation of the benchmarks, position papers, guidance documents, assessment tools, industry...
Automated Facility: Stirred tank unit interface specification
Typically, equipment skids (MTP process equipment assemblies (PEAs)) need to be treated as bespoke units when they are connected to control systems (MTP process orchestration layers (POLs)). This places automation on the critical path for facility design, build and reconfiguration. This document presents a stirred tank unit (STU) interface specification. The STU class of equipment includes single-use bioreactors (SUBs) which are central to the manufacturing operations of many companies producing biopharmaceuticals using a batch process at intermediate scales. By combining this specification with MTP, equipment and control systems, providers can enhance interoperability and reduce the equipment installation time from months to weeks or even days, depending on the installation scenario. And by providing good documentation to their customers’ quality systems, they can enable customers to reduce their internal validation effort.
A risk-based blueprint for process control of continuous bioprocessing
This paper gives an overview of an accompanying risk assessment template and acts as a blueprint for industry. It will be useful for any organization new to continuous bioprocessing, while experienced companies can use it to benchmark their existing operations.The blueprint will accelerate the realization of commercial continuous biomanufacturing processes and signals to regulators that this is the direction of industry travel, with a consensus view of how it should be done.The control plan will help lower the implementation barrier for starting continuous bioprocessing and provide a better understanding of its needs for end-users and potential vendors as it aligns and standardizes the industry’s validation approach.
Harvest Clarification: Harvest clarification URS version 2.0
This outlines biopharmaceutical manufacturers’ requirements for an improved harvest clarification solution that will operate with feedstream cell densities up to 150 million cells/mL in a single-use production scenario. The URS contains requirement details covering functional requirements (e.g. operating temperature and temperature change), qualification requirements (e.g. microbial control), quality requirements (e.g. biocompatibility) and supply chain requirements (e.g. lead times).It will give equipment vendors an understanding of what biomanufacturers foresee in this space and help them find solutions that are compact, relatively mobile and can manage these ultra-high cell density solutions.
Technology Roadmapping: Manufacturing technology roadmap tool
Biopharm Services has supported BioPhorum by modelling manufacturing options to identify the cost drivers and potential of technology options to meet these challenges. The Manufacturing technology roadmap tool allows users to view detailed outputs for baseline scenarios, interrogate and compare the options and access a set of benchmark baseline processes that represent an industry consensus for the first time.
Covid-19: How industry is using technology during the covid-19 pandemic
This article looks at the role of technology in the workplace and specifically how the Senior BioPhorum Connect group is addressing issues such as the use of remote working technologies, cyber security and digitizing the cGMP space.
New Technology Adoption
The Best Practice in Adoption of New Technologies workstream was formed in late 2019, and is seeking to deliver on a best practice framework for adoption of technologies into manufacturing environments. The biopharmaceutical industry is risk-averse when considering adoption of new technologies onto production lines. Key contributors to this have been identified as including, a need for improvement in business case assessment, a need for better alignment of stakeholders throughout the technology adoption process, both within organizations  (Business vs. R&D vs. Operations) and across multiple organisations and a perception that working with regulatory agencies can be challenging. The team have shared case studies on technology governance process and practice and are now working to create a collaborative best practice playbook for biomanufacturing This playbook will provide cross-industry guidance on stakeholder engagement and risk management, and best practice in building of technology business cases across multiple functions. The guidance will be able to be applied both within an organization, and collaboratively, enabling acceleration of new technology adoption across the industry.