Abstract
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.
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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.
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This paper addresses the need for a systematic and best practice approach to the evaluation, validation and implementation of these methods related to adventitious agents testing to support the adoption of alternative adventitious agent testing (AAT) methods. A nine-step framework and common language are described which can be applied by biopharmaceutical companies wanting to take advantage of the numerous benefits of ARMMs and alternative AATs.
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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.
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The data required to improve process performance and make better manufacturing operational decisions exists today, but in far too many cases it is scattered across multiple systems and exists in a wide variety of formats rendering it difficult if not close to impossible to assemble into context for evaluation, reporting and decision support. In too many facilities production, operations and quality management personnel spend the majority of their time gathering and contextualizing data rather than using consolidated data in context to imnorm the improvement process. The Big Data to Smart Data team are building on the opportunities first highlighted in the Automated Facilities Roadmap by developing an industry standard taxonomy / indexing approach for data sources, and proposing an architectural solution to add context to data when first created. Delivering direct benefits by reducing investigation and analysis timelines.
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This chapter of the first edition biomanufacturing technology roadmap published in 2017, describes the vision, scope and benefits that could be gained in the biopharmaceutical manufacturing industry from the development and implementation of effective automated facilities. To help the industry achieve this future state it describes the scenarios considered, the future needs, challenges and potential solutions as well as the linkages and dependencies on other parts of the roadmap. It considers the contribution that disruptive and emerging technologies can play and regulatory considerations before finalizing with conclusions and recommendations.
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Current trends in the biopharmaceutical industry, continued market growth, new product groups, cost pressures and the trend towards localized manufacturing exert unprecedented pressure on biomanufacturers to innovate biomanufacturing platforms. To accelerate the industry’s journey, a technology roadmapping process has been established to determine common biomanufacturer needs and to share them openly with supply partners, academics, regulators and government agencies so that directions can be aligned and collaboration enabled. The first edition biomanufacturing technology roadmap, published in 2017 is an initial step, setting a broad vision for the future of biomanufacturing and designed to catalyze industry action. This executive summary brings together the conclusion and recommendations of each part of the roadmap, overview, process technologies, automated facility, modular and mobile, in-line monitoring and real-time release, knowledge management, supply partner management and details the overarching next steps for the industry and this collaboration.
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This overview document, for the First edition biomanufacturing technology roadmap published in 2017, sets the context, provides an introduction to the roadmap and details the current and predicted landscape for the industry that creates the imperative to innovate.
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This chapter of the first edition biomanufacturing technology roadmap published in 2017, describes the vision, scope and benefits that could be gained in the biopharmaceutical manufacturing industry from the development and adoption of effective process technologies. To help the industry achieve this future state it describes the scenarios considered, the future needs, challenges and potential solutions as well as the linkages and dependencies on other parts of the roadmap. It considers the contribution that disruptive and emerging technologies can play and regulatory considerations before finalizing with conclusions and recommendations.
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This chapter of the first edition biomanufacturing technology roadmap published in 2017, describes the vision, scope and benefits that could be gained in the biopharmaceutical manufacturing industry from the development and use of a modular and mobile approach to facility design and creating. To help the industry achieve this future state it describes the scenarios considered, the future needs, challenges and potential solutions as well as the linkages and dependencies on other parts of the roadmap. It considers the contribution that disruptive and emerging technologies can play and regulatory considerations before finalizing with conclusions and recommendations.
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This chapter of the First edition Biomanufacturing technology roadmap published in 2017, describes the vision, scope and benefits that could be gained in the biopharmaceutical manufacturing industry from the development and adoption of effective in-line monitoring and real-time release capabilities. To help the industry achieve this future state it describes the scenarios considered, the future needs, challenges and potential solutions as well as the linkages and dependencies on other parts of the roadmap. It considers the contribution that disruptive and emerging technologies can play and regulatory considerations before finalizing with conclusions and recommendations.
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This chapter of the First edition biomanufacturing technology roadmap published in 2017, describes the vision, scope and benefits that could be gained in the biopharmaceutical manufacturing industry from the development and adoption of strong knowledge management capabilities. To help the industry achieve this future state it describes the scenarios considered, the future needs, challenges and potential solutions as well as the linkages and dependencies on other parts of the roadmap. It considers the contribution that disruptive and emerging technologies can play and regulatory considerations before finalizing with conclusions and recommendations.
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This chapter of the First edition biomanufacturing technology roadmap published in 2017, describes the vision, scope and benefits that could be gained in the biopharmaceutical manufacturing industry from the development and adoption of effective supply partnership management approaches to develop the critical suppliers for the industry. To help the industry achieve this future state it describes the scenarios considered, the future needs, challenges and potential solutions as well as the linkages and dependencies on other parts of the roadmap. It considers the contribution that disruptive and emerging technologies can play and regulatory considerations before finalizing with conclusions and recommendations.
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Climate change and global warming resulting from greenhouse gas emissions are widely recognized as the biggest threats to global health. The healthcare sector is responsible for 4–5% of global emissions, more than 70% of which are driven by supply chains.
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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.
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Buffers are critical inputs into all downstream processing steps associated with the manufacture of therapeutic proteins. The large volumes of buffer required present ongoing logistical challenges and account for a significant portion of a facility’s footprint, labor requirements and equipment costs. To address these challenges a collaboration of leading biopharmaceutical companies, engineering firms and suppliers has been working together to develop a design for a Buffer Stock Blending (BSB) System to support the preparation of buffers in-line and on demand from concentrated single-component stock solutions. These papers, in the first instance describe the project and activities up to the award of the contract to IPEC, the industry drivers for change and the novel approach to buffer preparation, and in the second paper deep-dive into some of the modeling work done to establish the economics and benefits of the approach.
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Anyone attempting to establish continuous downstream processing of therapeutic proteins will know that there are documentary gaps in technology and regulatory requirements. This industry review provides a gap analysis of a typical continuous mAb downstream process from primary capture to bulk drug substance. It does this to highlight the gaps that are preventing the use of continuous biomanufacturing with a goal of focusing industry and supplier efforts on generating solutions. These gaps are grouped into these categories covering, unit operation technologies, single-use technologies, automation, modeling and regulatory. The paper also defines common terminology to clarify their meaning. It is hoped that closing the gaps identified in this paper will turn the promise of continuous bioprocessing into a reality so that patients, biomanufacturers and suppliers may all benefit.
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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.
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The Digital Technologies Roadmapping team are seeking to apply a digital lens to the roadmap vision outlined in the Technology Roadmap and creating the same level of future vision for digital technologies that has existed for other biomanufacturing tech and approaches since 2017. To date the lack of a digital roadmap means it has been difficult to understand where technology gaps and interdependencies exist and it is challenging to coordinate implementation activities across functional areas. Biomanufacturers need clarity regarding on the needs, standardization and implementation of digital technologies across the industry. A practical roadmapping methodology is being applied to a number of digital topics, with the team focussing on Data Flow and Data Integrity in the first phase. The analysis that the team has completed to date is available for phorum members here.
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This paper outlines the foundational element that chart the course for pharmaceutical manufacturers who decide to take this journey and provides a vision of what that destination could look like in 10 years’ time. It outlines the current state of the industry, key challenges and barriers to adoption, and hints at the value that taking this journey will bring to patients, organizations and industry. This paper (which forms Part 1 of the Digital Technology Roadmap) looks at the problem statement and the work that has gone before.
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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.
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The goals of an effective in-line monitoring and real time release testing (ILM-RTRT) and predictive modelling strategy are to leverage enhanced process understanding, risk mitigation and process control improvement to reduce the reliance on end product testing while improving early detection of catastrophic failure. Additionally, ILM and RTRT will enable cost reductions, product and process consistency and speed to market while enabling continuous improvement. But of the multitude of critical quality attributes and critical process parameters, which should be prioritized first for transition from off-line monitoring to in-line/on-line/at-line monitoring? This paper not only answers the prioritization question but also provides supporting quantitative business case information along with technology-agnostic User Requirement Specifications (URS) for each of the attributes to serve as a guide for technology suppliers in the development of systems that will meet industry standards for ILM and RTRT.
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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.
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This User Requirements Specification (URS) document will provide a starting point for the biopharmaceutical industry to build true knowledge management (KM) capability. It is intended to help solutions providers innovate in the area of relevant tools and systems by providing guidance on the specific needs of operating companies. The design, implementation and maintenance of a comprehensive KM platform, solution or system is a complicated undertaking — this is because it should ultimately span many functions, disciplines, business processes and all products over their respective lifecycles.
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The management of knowledge in biopharmaceutical organizations has been recognized as an important challenge over recent years. Defining the pain points and designing successful knowledge management (KM) solutions have proven difficult. To address this challenge, BioPhorum Technology Roadmapping applied a KM best practice methodology to capture a process-based knowledge map for a major business process; this was performed by companies who develop and commercialize new therapies. The resulting assessment of knowledge flows revealed that there are significant challenges to both explicit and tacit knowledge flow across the control strategy and method development / technology transfer processes. Some generalized solutions have been proposed. As part of this work, a detailed spreadsheet tool was developed so that organizations can repeat this work on their business processes to understand their knowledge–flow issues and develop fit-for-purpose solutions. The knowledge mapping tool is available here. Detailed instructions are available within the tool itself. The data in the sheet reflects that used in the illustrative example documented in the companion paper. The data is intended to be removed and replaced with end users data in support of their own KM efforts.
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Traditionally, biopharmaceutical facilities can take up to three to five years from design through qualification before they are ready for full operation. Such facilities are often product dedicated, requiring significant and costly modification to accommodate additional products once the original product lifecycle has ended. This inherent inflexibility has become a major concern for the industry, especially given the increasing pressure to reduce costs and quicken the speed to market. To address these concerns this paper proposes a standardized design approach around an example facility solution for 2,000L-scale mAb application. The example facility focuses on demonstrating how a modular design approach may be realized using various construction methods – including traditional stick-built, prefabricated and skid assemblies, as well as modular cleanrooms or complete modular building units – without requiring major reconfiguration. At the core of this investigation is the intent to align the biopharmaceutical industry around a common understanding and approach to the design and construction of manufacturing facilities that makes the capital project process more predictable by, reducing schedule durations, improving project cost certainty, increasing facility design repeatability and ensuring greater regulatory compliance.
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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.
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The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) collaborated with BioPhorum to create and publish three technology roadmaps covering Vaccines, Gene Therapy and Antibody-Drug Conjugates/ Bispecific antibodies. Developed using the highly successful roadmapping process that led to the first edition of the BioPhorum Biomanufacturing Technology Roadmap. These documents compliment the original Technology Roadmap and detail the manufacturing challenges, technology needs and areas of opportunity in each of the three product categories with additional focus on US regulatory and workforce challenges.
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Presentation by Jeff Johnson on behalf of the NIIMBL-BioPhorum BSB System Team at BPI East September 2020
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Historically, the biopharmaceutical industry has relied on traditional pharmaceutical manufacturing practices to make and release products. This publication examines the future of biopharmaceutical manufacturing by presenting the vision of fully implemented in-line monitoring (ILM) and real-time release. This aspirational vision includes full ILM, predictive analytics and advanced process controls (APC) enabling release of product in real time, with concomitant predictive and preventative alerts and resolution of process, equipment and other production issues.
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Automation can improve efficiency, track performance, adjust operations, and liberate operators from mundane routines. Automation requires a flexible set of tools that align well with the inherent flexibility of single-use technology (SUT). Although SUT flexibility enhances a biomanufacturer’s ability to modify operations to meet the needs of today’s dynamic industry, it also increases timelines and costs related to customizing and validating automated additions. This paper presents the findings of a team of industry automation experts who are sharing their experiences and testing new automation methods, with a vision to a reusable, standardized approach that enables rapid integration of intelligent process skids.
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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.
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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.
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One of the main targets for BioPhorum Technology Roadmapping is to reduce the testing times for bacteria (including mycoplasma), fungi and viruses in biological therapeutics from four weeks to just one or two days. The objective of this white paper is to identify industry barriers associated with adoption of alternative rapid microbiology methods (RMM) for the detection of adventitious agents and to understand how that can be best overcome. As such this paper provides an outline of the current methods for sterility, mycoplasma and virus testing in use and their limitations and lead times. Furthermore the paper explores the drivers for change and the main factors preventing the use of alternative RMM for testing to assure sterility and the absence of adventitious agents in the manufacturing process. Finally it recommends approaches that can be used to cost, justify and make adoption of new RMM technologies a reality to address the limitations of current practices.
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Robotic systems first started making inroads in the biopharmaceutical industry through the implementation of high-throughput automated systems for drug discovery and analytical assays. Robotic systems now are making inroads in process development with the introduction of ambr and Tecan systems. In the next few years, our industry is likely to see more applications of robotic systems, particularly mobile and collaborative robots in warehouse and production floors of biomanufacturing facilities. This paper introduces potential applications for robotics in biomanufacturing, outlines the current availability of robotic systems, and calls robotics suppliers to adapt existing systems or develop new solutions for the biomanufacturing industry. It also highlights key challenges to the adoption of mobile robotics in manufacturing with the aim of getting the industry to start to address them
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Document designed to support the design of a checklist for technology readiness in an end-user company technology implementation program.
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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.
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