Changes to critical, complex systems in our regulated environments must be 100% right. This was recognized by the single-use industry and key customers some five years ago and resulted in a number of papers and much better alignment to a standard language and ways of working around single-use system change controls. However, there is always room for improvement and greater alignment in the industry, and the collective learnings have now been...
supply partnership management
Viewing related articles
This paper is intended to be an all-inclusive manual (a one-stop shop) on change notification best practices for single-use biomanufacturing systems. A summary of previous publications is also provided. This includes improvement updates to the decision tree and supporting table based on user feedback. This paper delineates the main attributes of an effective supplier change notification program. The team’s vision for this toolkit is to facilitate adoption of these practices by the majority of end-users and suppliers in the single-use supply chain. In time, it is hoped that these practices will become reflected in quality management practices and in formal business agreements.
In the second half of 2020, BioPhorum Drug Substance will publish a comprehensive set of tools and guidance to help the industry foolproof the transportation, deployment and use of single-use systems. Inspired by the work of Bayer's Berkeley facility, who over many years reduced leak rates from totally unsustainable 40% to a phenomenal 0.04%, the industry package takes the position that single-use systems are complex delicate...
Standards and best practices to support trace metal quantitation in cell culture chemically defined media and hydrolysates
In March, Dr Bala Ramanathan, Senior Scientist at Janssen presented the latest views, standards and best practices to Support Trace Metal Quantitation in Cell Culture Chemically Defined Media and Hydrolysates. The webcast (linked above/below) was organized by BioPhorum and USP. What the webcast covers Many elements such as copper, manganese, zinc, and iron have significant biological relevance, and are well established as key contributors to...
Oct 2019 |
Single-use technology is growing fast in the biopharmaceutical industry, but designing new single-use systems involves a long, iterative process between end-user and supplier to ensure quality, regulatory, and technical requirements are met. Wouldn’t it be convenient if all these requirements were captured in a toolkit? BioPhorum and BPSA have created templates aligned with industry standards (i.e. ASTM E3051) which will simplify the single-use design process. The Single-Use User Requirement (SUUR) Template helps end users to communicate process/application details and SU requirements to suppliers, who in return can affirm or describe their capabilities to meet these requirements. The Technical Diligence Templates are pre-populated with end-user requests for detailed information that describes how suppliers may fulfil specific user requirements. Supplier responses allow end users and suppliers to make informed decisions and reduce gaps in understanding. The Supply Chain Template allows end users to request supply chain-related information and gives suppliers with a dedicated document to respond to this request. These templates combine to provide the industry with a set of common user requirements, clarity on criteria for fulfilling these requirements, and a mechanism for transmitting supply chain-related information. Adoption of these templates will yield distinct advantages to both end-users and suppliers in terms of compliance, time, and efficiency. Quality and compliance is improved by documenting and aligning expectations. Further, the tools enable clear and consistent communication, fostering a right-first-time approach to the design of single-use components.
It is impossible to define the raw materials used in the biopharmaceutical industry with a single set of regulatory or compliance criteria. What is considered fit-for-function changes depending on the product attributes and the intended customer. This tool standardizes and structures the risk assessment process, addressing three fundamental questions when determining raw material fit-for-function: What user requirement is the raw material designated to perform? What material attributes are essential to the designated function and what might have unintended consequences? This paper helps improve communication between – and within – manufacturers and suppliers and enables users to make uniform, evidence-based decisions on risks and priorities concerning raw materials. An industry-wide methodology for the resolution of high-impact raw material variability issues.
Sep 2019 | Information Technology
Many biomanufacturers use a network of logistics service providers (LSPs) to deliver warehousing, transport and distribution services. Typically linked using customized, electronic, point-to-point connections. These connections can be expensive and slow to set-up and expensive to update in response to changing market demands. There is no dominant technical solution that monitors the condition and location of shipments, and that enables companies to adopt different solutions for different regions and partners. There is a need to raise the awareness of software vendors of this unmet need and the real interest of many industry stakeholders if a suitable LSP integration solution was available.
This paper provides an overview of the current needs of manufacturers and their technical integration with their network of LSPs. It contains a high-level requirements specification for a common, cloud-based, integration platform, that would reduce customization and multiple point-to-point solutions. The specification is designed to help technology companies develop this services. Informal benchmarking across member companies indicates that ‘collaboration hub’ use would deliver a 50–70% saving in time and cost when linking to a new partner. These benefits would be realized by both partners making the new connection.
The Raw Material Risk Management workstream has launched a new, raw material risk assessment tool aimed at helping industry identify and prioritize around the challenging question of material fit. In our high-stakes, highly regulated environment, as suppliers and manufacturers strive to meet a perpetual tide of new “regulatory standards, the supplier-biomanufacturer relationship can become strained. This new tool standardizes and structures the...
Jul 2019 | Change Notification
This tool allows users to document key stakeholders who are impacted by the adoption and implementation of the Industry Proposal for Change Notification Practices for Single-Use Biomanufacturing Systems with the purpose of identifying the cross-functional team members required to assist in the implementation and execution of the proposal, as well as the challenges and advantages associated with adoption and implementation.