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Media and hydrolysates

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

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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Electronic data exchange: a baseline survey summary

Electronic data exchange: a baseline survey summary

A benchmark survey which sets out to establish the baseline for electronic data exchange across participating members, to understand: How suppliers and biomanufacturers were working with EDE for raw materials across their inbound supply chain, whether they were using the ASTM standard and, if so, its application and value to their company and to provide Insights for improving EDE across the sector. The results cover utilization, prioritization, ASTM E3077-17 standard utilization and the benefits and challenges in implementing it, EDE maturity, benefits and challenges for EDE in the inbound supply chain, EDE accelerator and other conclusions.

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

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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Risk assessment of cells used in early development

Risk assessment of cells used in early development

This paper is the first in a series considering  real-world scenarios where the EHS companion risk assessment template has been completed.  This assessment focuses on cell expansion operations working with the cell line only in R&D labs to develop procedures and controls; it does not include production operations, such as transfection or viral infections. 

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“High-risk” host cell proteins (HCPs): A multi-company collaborative view

This database and paper provide a comprehensive review and list of potential problematic HCPs that could impact the safety, efficacy, and quality aspects of CHO-produced biologics during their development and manufacturing. They provide a reference on the best practice and control strategy for “high-risk” HCPs” in the biopharmaceutical industry.

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Manufacturing patching practices: safeguarding the manufacturing environment

Manufacturing patching practices: safeguarding the manufacturing environment

This paper presents seven BioPhorum manufacturing patching practices. It provides guidance to help focus your thoughts and ideas if you are tackling the same issues within your manufacturing environment. It identifies barriers that can make patching difficult (or even impossible) and proposes mitigation practices that you should consider to overcome these barriers and associated risks and use to support a successful program of patching within the manufacturing environment.

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