BioPhorum Drug Substance Closed Systems in Controlled Non-Classified Workstream has recently published its room...
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Sep 2021 | Technology Roadmapping
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.
An audit trail is a secure, computer-generated, time-stamped electronic record that allows the reconstruction of events around the creation, modification, or deletion of an electronic record. It should be in a clear and specific format and capture key data, including when (date and time), by whom (identity), where (location, terminal or device identification), and what (detail about the change). However, many end-users have significant issues...
BioPhorum members have given us a clear message; to be an industry that supports sustainability is extremely important to them. With no other single organization providing ‘one voice’ for the industry, discussions have been gathering pace to launch a dedicated sustainability phorum. This will become the prime vehicle to translate high-level corporate statements and commitments into practical, on-the-ground, scalable and transferable solutions....
BioPhorum strengthens supply chain resilience through digitization of the supply chain and alternatives to gamma sterilization
Since 2016, BioPhorum Supply Partner has made great progress in bringing together manufacturers and supply partners to build modern and effective inbound supply chains and develop a program of work that addresses some key areas: risk; planning; and education, qualification and control. Its industry expertise and ‘horizon scanning’ mean its transformative program reduces risk and adds value for members. This can be seen in the creation of two...
Automation is often on the critical path for facility build and reconfiguration projects. It has many benefits – such as increased consistency of operation and safety of personnel – but integration is often bespoke, and the cost and time of customization, connection and validation need to be carefully considered. Integrating key pieces of processing equipment through a ‘plug-and-play’ approach would greatly reduce project timelines and risks....
Jun 2020 | Technology Roadmapping
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.
Jun 2020 | Technology Roadmapping
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.
Jun 2020 | Technology Roadmapping
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.
Reducing the time-to-release for drug product is a key goal of the industry as it can lower production costs and accelerate speed-to-market. This is why BioPhorum has completed a significant piece of work on the development of in-line monitoring technologies, which are fundamental enablers of real-time product release. The result is a new and extensive white paper, In-line Monitoring/Real-Time Release Testing in Biopharmaceutical Processes –...
In-line monitoring / real-time release testing in biopharmaceutical processes – prioritization and cost benefit analysis
May 2020 | Technology Roadmapping
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.