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

Don't Miss a Bug with Real-Time Microbial Monitoring

Mettler Toledo

Measuring bioburden in pharmaceutical water systems has almost exclusively depended on time-consuming, error-prone, culture-based lab measurements. Developments in spectroscopic technology offer accurate, continuous, on-line determination of microbial contamination.

Effect of Extrusion Parameters on Solid Dispersions

C. Martin, J. DiNunzio, J.M. Keen, A. Machado, J.W. McGinity, H. Sandhu; Leistritz Extrusion

The objective of this research is to investigate the extrusion process space in co-rotating and counter-rotating extruders, which is critical in ensuring the properties of pharmaceutical solid dispersions.

Analysis of Tricyclic Analysis of Drugs of Abuse at Low and High pH using Agilent Poroshell HPH C18 by LCMS

William Long; Agilent

In this application note, LC/MS of several compounds associated with drugs of abuse are compared at high and low pH using a generic gradient in positive ion mode electrospray (ESI+).

Pharmaceutical Cleaning Validation

Malcolm McLaughlin; Alconox, Inc.

A comprehensive description of how to perform cleaning validations in the pharmaceutical industry.

Bio/Pharmaceutical Methods: Do your Analytical Methods Hold Up to Regulatory Scrutiny?

Jon S. Kauffman Ph.D and Cynthia Eby; Eurofins Lancaster Labs

As FDA guidelines evolve and drug products on the market begin to age, bio/pharmaceutical manufacturers face scrutiny of the original methods used to support these products. Therefore, manufacturers must re-evaluate these methods to ensure they comply with current FDA expectations. Some manufacturers are facing consent decrees imposed by the agency requiring them to bring methods up to current standards within a specified timeframe.