Build your pharma development and manufacturing knowledge base with the latest whitepapers, application notes, posters, and other educational resources from bio/pharma industry suppliers.

Protein Aggregate Analysis of Monoclonal Antibodies

The Thermo Scientific Vanquish Duo system for Dual employs two separate flow paths for simultaneous analysis of complex samples.

Continuous Twin Screw Extrusion System for Soft Gel Casing Replaces Batch Mixing Operations

From A technical review of compounding, devolatilization, reactive processing, foaming, and direct extrusion via twin screw extruders.

HR Multi-Attribute Method for Biopharma Analysis

This application note covers HRAM multi-attribute method for critical quality attribute monitoring and new peak detection, including optimization and application.

Finding Fakes – Using Raman Imaging to Identify Counterfeit Medicines

Identifying counterfeit drugs has become an area of increasing focus for regulatory authorities and also for pharmaceutical companies. Raman spectroscopy is highly specific and can differentiate between materials with similar chemical structures.

JPM CBRN Medical Teams with Janssen Vaccines and Prevention B.V.

The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) entered into a Letter of Agreement for Materials and Information Transfer with Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical companies of Johnson & Johnson on October 2, 2019. The Agreement defines assay validation submission protocol and reporting processes to the European Medicines Agency, and potentially other foreign regulatory agencies and authorities, to expedite its review of Janssen’s vaccine.

The Pharma Trends You Need to Know – A CDMO’S Perspective

Anil Kane, Ph.D., MBA

The market momentum of novel therapies targeting unmet needs is creating a new landscape for pharmaceutical drug manufacturers. As the focus on these smaller patient pools grows, so does the complexity of drug development. Companies must understand how the molecules filling today’s pipeline are changing our business, as they are causing a dramatic shift in how we plan for and execute drug development and manufacturing.

Cleaning Validation for Pharmaceutical Manufacturing

This paper outlines the basics of cleaning validation and discusses the support services you should seek from your critical cleaning products supplier to optimize your cleaning validation process.