A better approach to data management is needed to upgrade biotech and pharma operations to the conceptual standards of pharma 4.0, building on connected plants and instruments to enable real-time process monitoring, quality control, and product release
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There is an acute need for a standardized approach for certifications of analysis of chemical transfection reagents used in good manufacturing processes.
The BioPhorum Supply Partner quarterly survey asks biomanufacturers (large molecule Licence Holders and CDMOs and CGT/ATMP license holders and CDMOs) what their view of the likelihood that they will be pulling in physical materials to their manufacturing facilities
Closed systems are not a novel contamination control option. From a harmonized regulatory perspective, starting with ICH Q7, closed systems have been recognized for more than 20 years as a contamination control measure for low-bioburden active pharmaceutical ingredients.
Ethylene oxide (EtO) is one of the most widely used sterilization methodologies in the biopharmaceutical industry. A survey completed with BioPhorum members found that 69% of members use EtO sterilization for semi-finished inputs, components, and terminal products and devices.
For the most part, process performance qualification (PPQ) methodologies established for protein biologics can be leveraged for in vivo gene therapy processes and they often require similar validation support studies. There are, however, differences that are specific to gene therapy products and production processes that need to be addressed. PPQs typically require extensive non-routine in-process sampling and testing. This can be challenging...
A cyberattack can range in severity as can the impact. As manufacturing organizations enhance their level of digital plant maturity, they will increasingly rely on digital technology and electronic data. This paper sets out the rationale and approach to conduct a ‘tabletop exercise’ (TTE) that explores the readiness of operational technology (OT) and information technology (IT) support organizations to handle a
cybersecurity incident impacting a manufacturing plant.
Do you know how the European Chemicals Agency’s (ECHA) proposals on using per- and polyfluoroalkyl substances (PFAS) might affect you, your products and your patients? This is why BioPhorum and MediPhorum have submitted comprehensive analyses
Cybersecurity threats to biopharmaceutical manufacturing are increasing, especially those arising from code vulnerabilities. These threats are also getting more sophisticated and, if successful, will have a greater impact on the production of medicines. This paper focuses on cybersecurity vulnerability management and considers the challenges of exploitable code and protocol weaknesses and how to address these.
In 2016, the BioPhorum IT (BPIT) collaboration group created the original Digital Plant Maturity Model (DPMM) and high-level Assessment Tool to help you conduct single-plant and manufacturing-network assessments with a high degree of consistency. It described five maturity levels ranging from manual paper-based to the fully automated ‘adaptive’ plant of the future. Driven by the need to reflect progress made in available technologies and new...