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

Automated Quantitative Analysis of ADCs

Liuxi Chen, Steven Cubbedge, Ying Qing Yu and Rose Lawler; Waters

This application note describes how to perform ADC peptide quantitation using an accurate mass screening workflow and demonstrates the workflow capability of comparing key product attributes of ADCs across samples.

Aqueous Critical Cleaning: Applications In Pharmaceutical Manufacturing

Malcolm McLaughlin; Alconox Inc

The benefits of employing aqueous cleaning in pharmaceutical manufacturing are numerous. This whitepaper contains specifics to assist in pharmaceutical cleaning, and is used in conjunction with cleaning validation for pharmaceutical manufacturing.

Handling Combustible Dusts: Preventing Dust Explosions

David Kennedy; Vac-U-Max

Almost every organic material is combustible. Find out how VAC-U-MAX’s intrinsically-safe compressed air-powered industrial vacuums which meet NFPA 70 requirements for grounding and bonding, prevent dust exposure, and promote safer plant environments. Download this whitepaper.

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

G. Terife, C. Martin, C. G. Gogos and 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.

Comparative Human in-vivo study Using OverEncapsulated Capsules

Ven Stegemann, Sudershan Vishwanath, Ravi Kumar, Dominique Cade, Missy Lowery, Keith Hutchison, Michael Morgen, Aaron Goodwin and Chang Lee; Capsugel

Rapid and consistent in-vivo drug dissolution is critical for drug absorption. In-vitro dissolutions tests are used to predict in-vivo disintegration and dissolution properties of drug products. The in-vitro disintegration and dissolution times of tablets and capsules can vary significantly based on their composition and processing. Though small differences in-vitro dissolution are not expected to result in significant in-vivo performance differences, the slight in-vitro dissolution delay observed by over-encapsulation for double blind clinical trials, as well as switching from gelatin to HPMC capsules often raises concerns on the potential impact on in-vivo bioavailability.

Pharmaceutical Compliance that Spans the Supply Chain

Tim Lozier; ETQ

Learn why global harmonization is important in the pharmaceutical industry and best practices for extending the quality system to the supplier.

UPLC Analysis of Methoxy & 2-Hydroxypropoxy in Hypromellose

Natalia Belikova, Willard Laster, Ervin Rozsypal and Gayla Velez; SGS

The USP has established standards relating to the amount of methoxyl and 2-hydroxypropoxyl substitutions in hypromellose. Here we describe the validation of an assay using UPLC method for simultaneous analysis.