Strategies for Successful Scale-Up Using Quality by Design
Sponsored By: DPT Laboratories
This executive summary will outline best practices for ensuring successful scale-up for manufacturing finished drug products by offering a systematic approach and technical case studies for implementing QbD through development to scale-up to commercial manufacture.

Product Manufactured for Its Intended End Use
Author: Dora Meissner
Sponsored By: BioSpectra
The goal of manufacturing a product for its intended end use provides an additional level of security to the product.

A New Developmental Grade of HPMCAS That Has a Lower Glass-Transition Temperature
Author: Sakae Obara
Sponsored By: Shin-Etsu Chemical Co., Ltd.
A new developmental grade of HPMCAS was evaluated. This grade has a lower Tg compared to the conventional grade and can be extruded at a lower temperature in the HME process.

Devolatilization/Solvent Extraction via Twin Screw Extrusion
Author: Charlie Martin
Sponsored By: Leistritz
Devolatilization (DV) is the process by which various amounts of unreacted monomer, solvent, water, or other undesirable volatile contaminants are removed from a polymer melt. A twin-screw extruder (TSE) is a device that is commonly utilized to compound polymer formulations to facilitate specific end-product performance. Oftentimes, there are chase impurities in the polymeric system that need to be cleansed, sometimes as a result of tighter governmental or commercial standards, or due to the deleterious effects the residuals may have on final product properties.

Cleaning Validation for Pharmaceutical Manufacturing
Author: Malcolm McLaughlin
Sponsored By: Alconox
This whitepaper describes the why, what, and how of cleaning validations in the pharmaceutical industry.  This paper includes who should be involved, what type of data needs to be generated, limit determination and equations needed for calculating needed values, as well as how to use the equations.

Investigation of Synthetic Compounds in Drug Discovery by Integrated HPLC and LC/MS
Sponsored By: Shimadzu
This paper introduces an analysis of eight pharmaceutical substances in a workflow that is typically used for pharmaceutical synthesis confirmation analysis. It describes an example in which measurement was conducted for a range of compounds with properties spanning acidic to basic, and high to low polarity.

ATCC^® Minis Support the Microbiological Quality Control of Pharmaceutical Products
Sponsored By: ATCC
Contamination of pharmaceutical products by objectionable microorganisms is a major concern within the pharmaceutical industry as it places product integrity and patient safety at risk. Pharmaceutical companies must safeguard the quality and safety of their products by thoroughly testing raw materials, equipment, environmental surfaces, and final preparations for microbial contaminants that may have been introduced inadvertently during or subsequent to the manufacturing process. Learn more about ATCC’s commitment to the microbiological quality control of pharmaceutical products with ATCC^® Minis.