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Raw Materials: Trace element variation of soy hydrolysate used in biopharmaceutical manufacturing

Raw Materials: Trace element variation of soy hydrolysate used in biopharmaceutical manufacturing

It is important for biomanufacturers to understand trace element variation within soy hydrolysates (by knowing the minimum, maximum and average concentrations), so they can determine if the degree of variation has an impact on their process. The knowledge gained through process characterization across the maximum variation found in soy hydrolysates can be evaluated to determine if it has an impact on the biomanufacturers’ process or product on a product-byproduct basis.

This is the first in a series of proposed hydrolysate white papers. The purpose is to educate users of hydrolysates of the various characteristics that they should be aware of to manage their processes. There are many parameters to consider within a hydrolysate. The intention is to start with data that can be collected on as many different hydrolysates used in the biopharmaceutical industry.

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TVR: Determining testing validation and release requirements for single-use systems through risk assessment

TVR: Determining testing validation and release requirements for single-use systems through risk assessment

When testing single-use items for biopharmaceutical manufacturing, when is it appropriate to leverage vendor data, and when does the end-user need to carry out testing? Is current regulatory guidance clear and sufficient in the fast-moving area of disposables? This best practice guidance has been developed as one of a suite of tools designed to assist the industry in providing a risk-based approach to testing requirements.In the rapidly evolving area of single-use systems (SUS), the industry will benefit from standardization while leveraging risk-based approaches to testing requirements to ensure compliance of parameters that are important for the process and product quality. This document establishes best practice guidance on how to use risk-assessment methodology to evaluate the level of testing needed to qualify and release SUS.

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Change Notification: A guide to change notification packages for single-use manufacturing systems

Change Notification: A guide to change notification packages for single-use manufacturing systems

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.

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Forecast template

Forecast template

When biomanufacturers and their suppliers discuss future demand for materials, a robust forecast is crucial to provide a structure for a transparent and open conversation between both parties. It is the simplest, least expensive risk mitigation tool they have, and forecasts are often crucial in executed supply agreements. This template can be used to define the recommended minimum data required in a forecast and will help improve the maturity of industry-wide forecasting practices.

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Extractables testing of polymeric single-use components used in biopharmaceutical manufacturing

Extractables testing of polymeric single-use components used in biopharmaceutical manufacturing

This revised extractables protocol for polymeric single-use components in biopharmaceutical manufacturing is based on an extensive scientific review and represents the combined opinion of the biopharmaceutical manufacturers and, crucially, the supply chain. It will reduce costs and focus people on the important data points. The protocol provides guidance on the suggested methods for extractables studies, including sample preparation, extraction conditions, recording test-article sampling conditions, and reporting data from the analysis of extracts. Flexibility is built-in, allowing suppliers to alter many study parameters due to restrictions based on the use of SUS, physical form factor, chemical compatibilities, etc.

The new protocol includes significant changes to the 2014 version, including the removal of 5M sodium chloride and 1% Polysorbate 80 as extraction solvents, the elimination of the time-point zero interval, and the elimination of elemental analysis of 50% Ethanol extracts.

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Extractables: Single use supplier extractable reporting pack

Extractables: Single use supplier extractable reporting pack

Consistent reporting and presentation of extractable data by suppliers is critical to the fast and reliable assessment of single use systems by users for new solutions. The BioPhorum approach to reporting and presenting extractable data is now the industry standard and adoption of this approach enables all single use suppliers to fit together in an industry ecosystem that effectively supports the continued growth of adoption of single use technologies in biopharmaceutical manufacturing. This pack contains a guide and documents to help single use suppliers and integrators set up their webpages papers and present their extractable data in a way that aligns with the industry standard and extends the ecosystem. Once implemented this approach enables integrators and biomanufacturers to build an extractables profile for a system without needing to transcribe the data, saving time on new designs and minimising the need for expensive custom extractable studies.

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Single-use user requirement (SUUR) toolkit

Single-use user requirement (SUUR) toolkit

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.

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Raw material:  A holistic approach to raw material risk assessments through industrial collaboration

Raw material: A holistic approach to raw material risk assessments through industrial collaboration

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.

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Single-use, change notification: A guide to the classification of changes to SU manufacturing systems

Single-use, change notification: A guide to the classification of changes to SU manufacturing systems

The biopharmaceutical industry is increasingly dependent on the use of single use systems to enable manufacturing. These systems are often customised and built from many parts, from a range of component suppliers. Change notification and change management in this complex ecosystem is very difficult unless all suppliers, integrators and users follow the same system and standards for change notification. This guide provides guidance on the classification of changes, helping those implement the best practice establish consistency in their teams and thereby helping them adopt the change notification practices more effectively. Adoption of these practices enables your company to connect more effectively with the global supply chain and avoid the impact and delay from misunderstood change notifications

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