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Bringing clarity to trace element variations of hydrolysates

Protein hydrolysates are an essential component in cell culture medium formulation during the manufacture of protein therapeutics. However, as they may be derived from microbial, plant or animal sources, variations in their composition are unavoidable. This poses a potential risk to biomanufacturing as cell lines and products may be sensitive to slight variations in the hydrolysate composition, which may have an impact on process performance...

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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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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...

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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...

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China: Registration of raw materials entering the composition or presentation of biopharmaceuticals

Since 2017, it has been mandatory for suppliers of APIs, excipients and packaging materials to register their material in China on the DMF registration platform. While many agencies ask for details of a component’s quality and its impact on products, the Chinese requirements for ‘high risk’ materials, such as those used in biopharmaceuticals, also ask for historical information that is typically proprietary which many suppliers are reluctant to share. This paper summarizes the requirements for raw materials in other ICH countries and compares these to the Chinese approach. The paper also lists all of the details needed for the Chinese registration of biopharmaceutical products’ raw materials in a single place, to help suppliers register their products into this vast market.

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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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Proactive prioritization: a new tool for assessing raw material risk

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...

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Forecasting and supply planning: A best practice guide for the biopharmaceutical supply industry and assessment tool

Forecasting and demand planning are not well develop or effective integrated between biopharma manufacturers and suppliers in comparison with other industries with complex supply chains. This inhibits the ability of the sector to develop effective and agile supply chains to support rapid growth of products and is a major cause of shortages and the remedial work needed to keep supply chains functioning and products available. Leading end users and suppliers have undertaken considerable work to find solutions to enable biomanufacturers and their suppliers to plan commercial biologic drug manufacturing more effectively. This Forecasting and supply planning: a best practice industry guide, and the companion assessment tool defines the participating biomanufacturers’ and suppliers’ perspectives of the current state of the industry, the roadblocks to success and takes a ‘blue sky vision’ of best practices and the business case for changing the current situation.

In order to define, prioritize and measure improvement opportunities across the industry, the Forecasting and Supply Planning maturity assessment enables organizations to assess their status in relation to industry norms and best practice. More importantly, an assessment’s results provide a blueprint for the strengths and weaknesses that an organization needs to address to elevate its forecasting and supply planning processes.

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Biomanufacturing technology roadmap: 8. Supply partnership management

This chapter of the First edition biomanufacturing technology roadmap published in 2017, describes the vision, scope and benefits that could be gained in the biopharmaceutical manufacturing industry from the development and adoption of effective supply partnership management approaches to develop the critical suppliers for the industry. To help the industry achieve this future state it describes the scenarios considered, the future needs, challenges and potential solutions as well as the linkages and dependencies on other parts of the roadmap. It considers the contribution that disruptive and emerging technologies can play and regulatory considerations before finalizing with conclusions and recommendations.

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