raw materials


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BioPhorum’s strategic framework shines a light on raw material management

Biopharmaceutical companies rely on a dependable supply of raw materials to ensure they can produce life-saving medicines for patients. However, raw material variability is not fully understood between suppliers and manufacturers, which impacts yield and process continuity. There is also a poor understanding of raw material attributes, so the regulatory approach is not optimized, making changes difficult. Addressing these issues is a huge...

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Building on industry feedback to standardize plasmid release specifications

Plasmids release specifications are critical to the manufacture of many cell and gene therapy (CGT) products, but current regulatory guidance is limited in defining expectations for the release of plasmids as a starting material. BioPhorum has been highly active in this area and its most recent paper BioPhorum raw materials: cell and gene therapy critical starting material – further discussion on plasmids to establish release specifications...

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Raw materials strategy

This document communicates a strategic framework for solving technical problems relating to managing raw materials in the biopharmaceutical industry and encourages biopharmaceutical end-users and suppliers to work together to address specific raw material and end-user process needs. It highlights the importance of implementing industry solutions and sign-posts a range BioPhorum raw materials publications. These establish standard definitions, a common understanding of raw material requirements, and the importance of regulatory, quality, and supply chain links.

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Discussion on plasmids to establish release specifications using a risk-based approach to manage supply

This paper shares industry feedback after the publication of two BioPhorum papers that complement ongoing efforts in the wider CGT field. It supplements these publications by delving into identity testing and cross-contamination for plasmid master cell banks and plasmid DNA, and other plasmid DNA release tests (including DNA homogeneity, residual DNA and host RNA, and sterility or bioburden).

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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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