Technology Roadmapping

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Automated Facility: Stirred tank unit interface specification

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.

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A risk-based blueprint for process control of continuous bioprocessing

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.

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Harvest Clarification: Harvest clarification URS version 2.0

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.

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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.

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New Technology Adoption

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.

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Digital Technologies Roadmap

Digital Technologies Roadmap

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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Big Data to Smart Data

Big Data to Smart Data

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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In-line monitoring / real-time release testing in biopharmaceutical processes – prioritization and cost benefit analysis

In-line monitoring / real-time release testing in biopharmaceutical processes – prioritization and cost benefit analysis

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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Knowledge management: User requirements specification for a knowledge management system for use in a biopharmaceutical setting

Knowledge management: User requirements specification for a knowledge management system for use in a biopharmaceutical setting

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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