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 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.
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.
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.
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.
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.
The purpose of this best practice guide is to provide key information and best practices for media supplier partners and companies in the biopharmaceutical industry on the design, development and controls for manufacturing of media and medium solutions to minimize potential variation that may impact product quality, process performance and operational efficiency and costs. It is intended that it can be used to support a proactive approach to evaluation and self-audit of internal processes.
Raw materials: Cell and gene therapy critical starting material: a discussion to help establish release specifications for plasmids and the bacterial master cell banks used to produce them
BioPhorum Cell and Gene Therapy is asking for your help – and is giving you the opportunity to have a say in a scientific community discussion that will influence its suggested testing practices for plasmid release specifications. The team is proposing a platform framework for testing plasmid master cell banks and plasmid DNA.
Raw Materials: Perspectives on raw and starting materials risk assessment for cell and gene therapy (CGT) processes
The risk assessment of raw materials in the biopharmaceutical industry has been the subject of much study and review. The cell and gene therapy (CGT) field has the potential to revolutionize the healthcare industry. It utilizes novel manufacturing processes and has distinctive requirements for raw or starting materials. This paper outlines some of the unique challenges for raw materials as addressed by CGT manufacturers when working with the suppliers of materials. Case studies are presented to provide practical examples of the application of a risk matrix approach to the CGT industry and to highlight some challenges of managing raw materials for CGT 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.