Malvern Instruments Presents Solutions to Characterizing Sub-Micron Protein Aggregates
In an upcoming webinar on the 26th June, 2014, Malvern Instruments will present new experimental data demonstrating how Archimedes Resonant Mass Measurement (RMM) helps developers meet evolving regulatory challenges facing the biopharmaceutical industry. ‘Protein aggregation — Bridging the sub micron gap’ will explore how the Archimedes system enables formulators to characterize and quantify sub-visible particles within biotherapeutic formulations between 0.1 and10 µm. By accessing this previously challenging size range, the Archimedes allows developers to meet regulatory requirements to monitor aggregate formation throughout the entire product shelf life.
The formation of protein aggregates is a particular concern for biopharmaceuticals requiring parenteral administration because of the potential for increased immunogenicity. As a consequence, there is an expectation from regulatory agencies for developers to monitor levels of sub-visible particles present in therapeutic protein products initially and over the course of the shelf life. Presented by Dr Matthew Brown, Product Technical Specialist — Life Sciences, Malvern Instruments Ltd, the webinar will provide an overview of the challenges involved in characterizing and quantifying these sub-visible species. Dr Brown will demonstrate how innovative Archimedes RMM technology delivers quantitative particle analysis across a dynamic size range with the specificity to distinguish between negatively buoyant protein aggregates and positively buoyant particles, such as silicone oil — a capability beyond the scope of conventional protein characterization techniques.
Archimedes counts and characterizes particles by passing a sample across micro electro-mechanical system (MEMS) sensors comprising of a cantilever which resonates with a particular frequency. Each particle which passes across the sensor causes a change in the resonant frequency, giving an accurate and precise measurement of the particle’s buoyant mass — whether positive or negative — in the sample. From this measurement, the mass, size and surface area of the particle can be accurately calculated to quickly and simply deliver measurements of sample concentration, density, volume, and polydispersity. By providing advanced insight on a molecular level, the Archimedes allows users to gain the deeper understand of their formulation required to meet the evolving needs of biopharmaceutical regulation.
Register at www.malvern.com/submicron
Related News
-
News Pharmapack Awards 2024 Patient-Centric Design Award Winner – Dr Ferrer BioPharma
The 2024 Pharmapack Awards celebrated the best in innovation and design for the pharmaceutical packaging and drug delivery industry on January 24, 2024. -
News Women in Pharma: Minding the Gap at Pharmapack 2024
2024 marks the first year Pharmapack will host a Diversity track dedicated to bridging the gap within the pharmaceutical packaging and drug delivery sector. The track includes a panel discussion on 'Enabling Diversity in the Workplace,' focused... -
News Pharmapack Awards 2024 - Celebrating Packaging and Drug Delivery Innovation
The 2024 Pharmapack Innovation Awards ceremony celebrated the best in pharmaceutical packaging and drug delivery innovation at all levels. The awards were held on January 24, 2024 at the Paris Expo Porte de Versailles. -
News 2024 Pharma Industry Trends Outlook: Collaboration, Market Maturity, and Digital Futures
The annual CPHI Online 2024 Pharma Trends Outlook, in partnership with Arvato Systems, identifies 12 key industry trends shaping the life sciences industry in the coming year. -
News New Novo Nordisk AI hub for drug discovery to open in London, UK
Danish pharmaceutical giant Novo Nordisk will be opening an AI-based research facility in the heart of London to advance drug discovery operations. -
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Women in Pharma: Looking back on 2023 and moving forward to 2024
In this monthly series, we interview women from across the pharmaceutical industry and supply chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. -
News CPHI Barcelona 2023: Partnering for Success – Managing Outsourcing Relationships to Optimise Manufacturing Operations
During CPHI Barcelona 2023, insightful content sessions offered attendees the chance to explore trending topics with expert speakers and panellists. Here, we summarise what the pharma industry and supply chain are talking about the most.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance