Drug Development

Articles

The companies will develop a new generation of biotherapeutics from cell-line development through to GMP manufacturing.

ProBioGen, Abcuro Partner on New Gen Biotherapeutics

StarTab from Colorcon was designed to ensure functionality and stability for direct compression tableting.

Starch-Based Excipient for Direct Compression

Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.

A Study of Leachable Silicone Oil in Simulated Biopharmaceutical Formulations

Ashland introduces Klucel EXF Ultra HPC, a low friability, high strength binder. 

HPC Binder Designed for Small Tablets

Automated candle and pressure-plate filtration equipment for removing catalyst residues from API slurries are operated in a closed system.

Considering Alternative API Filtration Technologies

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Knowing the source and understanding the impact on CQAs is crucial to optimum drug formulation and processing.

Avoiding Excipient Variability

Andrew Johnson is analytical specialist with Gaylord Chemical Co, LLC.

Ashley Jones is analytical chemist with Gaylord Chemical Co, LLC.

In Karl Fischer analysis, sulfur trioxide can react with DMSO, invalidating test results. The authors evaluated different instruments and methods, described in this article, to minimize the impact on results.

Testing for Water in DMSO: Exploring Alternatives to Volumetric Karl Fischer Analysis

Large biopharmas, emerging biotechs, and CMOs are looking for novel ways to improve the productivity of biologics in a rapidly evolving biotherapeutics market.

The Search for Bioprocess Productivity Improvement

Cambrex’s expanded quality control laboratory supports generic API development.

QC Lab Extends Capabilities at Cambrex’s Milan Facility

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.

APIs and Excipients