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

Take the Online Quiz on Part 11 and Read a Breakdown of Both “Elevens”

Vaisala

This article provides an overview of three focal points of both Annex 11 and 21 CFR Part 11, including: system controls, validation, and archiving.

The Binding of Peroxide-Sensitive APIs: Typical Challenges and How to Overcome Them

BASF

Excipients are crucial for effective drug formulation and excipient manufacturers continue to make advances in technology designed to address the formulation challenges presented by new drug substances. Pharmaceutical Technology magazine talked with Dr. Bernhard Fussnegger, global development and technical marketing at BASF, about the excipient developer’s family of peroxide-free excipients that are recommended for APIs sensitive to oxidation.

Foaming via Melt Extrusion for Improving the Grindability of Extrudates and Dissolution Rate of Oral Dosages

G. Terife, C. Martin, N. Ioannidis; Leistritz

Significant development efforts are occurring that utilize twin-screw extruder (TSE) technologies as part of unique foam extrusion systems for emerging bioplastics and pharmaceutical products.

Building the Future: Using Simulation Effectively

Baxter

This white paper provides an in-depth look at Baxter BioPharma Solutions’ latest expansion at their cytotoxic manufacturing facility in Halle, Germany, providing insight on the handling of complex expansion projects, elements of process design, application of different simulation and visualization tools, Innovations for manufacturing of parenterals, and effective team building.

Cleaning Validation for Pharmaceutical Manufacturing

Alconox

This paper outlines the basics of cleaning validation, and discusses the kinds of support services needed for critical cleaning products in order to optimize a cleaning validation process.

How to Enhance Collaboration with the FDA

Tim Lozier; EtQ

In this whitepaper, learn about benefits and best practices of using the FDA’s eMDR program and best practices of implementing an eMDR system to meet specific business needs.

A Novel Approach to Cleaning Validation for Pharmaceutical Manufacturing by Online SFE/SFC

Shimadzu

Cleaning validation is necessary to establish the quality and safety of pharmaceutical drug products. The use of HPLC has increased due to the growing need for the individual analysis of products. However, manual sample prep processes may affect the quality of results. This paper evaluates the application of a novel on-line supercritical fluid extraction/chromatography system for cleaning validation.

Generics Companies Seek New Revenue Streams

Ken Phelps; Camargo Pharmaceutical Services

Readers will gain insight into why generic developers are choosing the FDA’s 505(b)(2) pathway to bridge revenue gaps, how viable products are identified, and models for development.