Raw material risk assessment has become more focused on industry and regulatory. The BioPhorum Raw Material Risk Assessment guides the interpretation of upcoming requirements. Collecting appropriate information from manufacturers and suppliers to conduct risk assessments efficiently and appropriately is challenging. Learn about the risk criteria of the BioPhorum Raw Material Risk Assessment and how the Emprove® Program can support and facilitate raw material risk assessment.
By Dimitrios A. Lamprou, Queen’s University Belfast
The limited ability to selectively deliver new drug molecules in the forms of peptides and proteins remains a significant challenge. Therefore, new materials and manufacturing techniques are emerging to meet the challenges associated with the formulation and delivery of biopharmaceuticals and pharmaceuticals.
Due to the pandemic, we have had to reconsider our approaches to supply chain risk management and to develop new and creative risk management strategies and tactics in response. This article examines how data integrity principles mitigate ALCOA concerns during this period of zero trust.
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By Temitope Sodunke, Ph.D.,BD Medical - Pharmaceutical Systems
Explore a wearable solution designed to enable new delivery formats in alternate settings with customization to support adjustments and variations in treatment regimens. This article discusses the BD Evolve™ On-body Injector and describes how the device is specifically designed to meet patient requirements and address the rapidly evolving needs of the pharma industry.
Increasing demand for messenger RNA (mRNA) as a therapeutic product requires efficient and scalable purification methods. In this application note on CIMmultus® Oligo dT, a monolithic stationary phase is used for purification of mRNA from a capping mix of Luc2 RNA. The large channels and convective mass transfer within the stationary phase eliminate shear forces and allow high flow rates, which leads to very short purification times and high recoveries.