raw materials

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Why BioPhorum’s trace element approach will save you time, money and wasted batches

Drug products can be heavily impacted when raw materials cause variability – anecdotal evidence suggests that batches worth millions of dollars are sometimes discarded due to trace elements coming through the supply chain. Not only does this increase costs and significantly impact production scheduling, but it could delay the manufacture of drugs that may, ultimately, impact patients. Yet, despite these industry-wide issues, there is no...

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Media and hydrolysates

This paper discusses the issues around trace elements and gives a suggested approach for developing a method for analyzing trace elements in cell culture media and hydrolysates. The approach is based on a ground breaking BioPhorum collaboration that shared blinded data and compared analytical methods between biopharmaceutical and media manufacturers.

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How to understand and mitigate the problem of trace element variation

A reliable supply of life-saving drugs requires understanding and mitigating any variability to support consistent supplies. However, the crucial timelines for making a drug product available to patients can be heavily impacted when variability is introduced through raw materials such as cell culture media (CCM) and reagents. Investigating a failure in production is costly and time-consuming and can delay product supply to the market – so a...

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Trace element variation for chemically defined cell culture media: biopharmaceutical industry requirements and cross-company collaboration to mitigate risks

A proactive risk-based approach to understanding key factors that can introduce product variability is necessary to avoid delays. One such factor identified is elemental impurity variability introduced by cell culture media. Though the impact of the variability will differ, it is important
that both manufacturers and supply partners understand the sources of elemental impurities and perform risk assessments to identify mitigation strategies. Such assessments will allow an understanding of the level of risk, and what steps may be taken to dissipate it. This paper is an effort to drive regulatory bodies, drug manufacturers, supply partners and N-1 suppliers toward a common understanding of the problem and possible solutions that can be taken towards risk mitigation. Though there may not be a single or ideal solution for this issue, a common rational approach can be taken by all parties to understand the impact on their processes and products, to drive identification of mitigation strategies.

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The four steps for registering innovative and complex raw materials

The Covid-19 pandemic has put extra strain on an already stretched biopharmaceutical supply chain. As industry has grown exponentially over the last couple of years, there has been an increased demand for materials and many existing products share these with the new Covid-19 vaccines, testing kits and therapies. As a result, these materials have been diverted to this high-priority use.  The pandemic has therefore demonstrated that reliance...

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BioPhorum approach to the registration of innovative raw materials using quality by design (QbD) principles

BioPhorum has defined a best practice approach to the registration of innovative and complex raw materials. The approach is based on quality by design(QBD) principles. It is applicable to different families of non-compendial raw materials in the manufacture of biologics. The approach has already been used by BioPhorum member organizations and accepted by national health authorities.

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A simplified way to register complex and innovative raw materials in Europe

The regulatory environment for registering innovative and complex raw materials differs by region and country. All national health agencies need to ensure that products proposed for their markets are safe, effective and of appropriate quality, so they need sufficient information to make that assessment. Most national health agencies have a knowledge platform where raw material suppliers can provide information on non-compendial materials –...

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Industry proposal for a simplified registration process of complex and innovative raw materials in Europe

This paper proposes a solution, applicable to all innovative and complex raw materials, to the challenges the biopharmaceutical industry faces with the registration of complex and innovative raw materials in Europe. The biopharmaceutical industry has designed a direct solution to the issue and identified a way to higher quality regulatory submissions, enhanced knowledge, understanding, control and robustness of its products and processes.

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Supplier change notifications – bringing color to a grey area

Regulators require the biopharmaceutical industry to manage changes to raw materials in a compliant way – including those initiated by suppliers. A significant challenge is how to manage the large volume of supplier change notifications (SCNs) while ensuring a compliant and uninterrupted supply of materials for production. Companies often need to manage hundreds of raw material SCNs per year, potentially covering hundreds of materials from a...

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Raw Materials: Supplier change notifications: change areas and requirements

This guidance document identifies the relevant change areas, and for each area, exemplifies the type of changes which the biopharmaceutical industry needs to be informed about. It also lists the required information, in terms of supporting data and documentation, to support notification of changes. This guidance is relevant to all raw materials used to produce biopharmaceutical products, including but not limited to cell culture media, fermentation broth components, column resin, buffers, solvents, and excipients. By highlighting the changes biopharmaceutical industry end-users need to know about and specifying the information required, the intention of this industry-aligned guidance is to reduce the quantity of rework required and the time taken to process change requests. In turn, this will reduce variability in demand patterns as end-users refrain from building extensive inventories to mitigate against the perceived risks which arise from proposed changes. While complete alignment and standardization on the information which should be provided for changes is not possible, a more robust alignment on the typical information required, as set on in this guidance, will significantly improve the current state.

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