Method Validation – USP Proposed <233>
Authors: Tania Russell, Pamela Hecht, and Nikki Schopp
Sponsored By: SGS Life Science Services
The new USP <233> describes testing methods to detect elements of interest specifically, accurately, and with high sensitivity, enabling detection at levels of ppb and lower.

Analysis for Polysorbate 80 Using New High Performance Liquid Chromatography (HPLC) Method with Charged Aerosol Detection (CAD)
Author: Lindsay L. McNalley
Sponsored By: Impact Analytical
Polysorbate 80 (polyoxyethylene (20) sorbitan monooleate) is a common nonionic surfactant, emulsifier and solubilizer that is used in a wide variety of industries and applications. Polysorbate 80 is typically used in food products, cosmetics, medications, vitamins, and vaccines. There can be many reasons a company may need to determine the exact amount of polysorbates in their material. For example, companies may need to determine AIG limits in their products, validate analytical methods for product production, or require the information for reverse engineering purposes. Thus, a well-developed analytical method is crucial for accurately quantitating polysorbates.

4 Benefits of Automated Rapid Detection & Enumeration
Sponsored By: Rapid Micro Biosystems
Few pharmaceutical manufacturers can afford to compensate for inefficiencies with large inventories. Fortunately, leaner methods are now available! Learn how pharmaceutical companies can benefit from implementing automated rapid detection and enumeration into their microbial quality control processes.

Managing the Complexities of Global Pharmaceutical Sourcing
Sponsored By: DPT Laboratories
With the increased globalization and complexity of the pharmaceutical supply chain, managing the sourcing of materials has become extremely challenging. Reducing time and costs are important goals of sourcing, but increased regulations and more rigorous enforcement make these goals difficult to achieve. These trends have forced life science industry companies to optimize sourcing activities for raw materials, intermediates, active pharmaceutical ingredients (APIs), and other material components for clinical supplies and commercial manufacturing. Download this white paper to learn more.

Melt Extrusion – Shaping Dosage Forms in the 21st Century
Authors: Charlie Martin; Feng Zhang, PhD; James C. DiNunzio, PhD
Sponsored By: Leistritz
Melt extrusion has been an established industrial manufacturing technology for more than 50 years. It is only in the last decade or so that it has emerged as a viable platform for pharmaceutical development. Today, applications of melt extrusion range from controlled release systems to oral bioavailability enhancement and show potential for small molecules and therapeutic peptides.

Anticipating success: Meeting the Inherent Challenges of Complex Drug Substances
Sponsored By: Vetter Pharma International GmbH
Realizing the full potential of a novel injectable drug compound is no small task. Unexpected scientific and technical challenges can slow development to a halt. Learn more about practical solutions (e.g. sterile process design, stability analysis).

Implementing Disposable Cleanroom Apparel into the Manufacturing Process
Author: Damon Larking
Sponsored By: Kimberly-Clark Professional
This paper addresses the benefits of disposable cleanroom apparel versus reusable apparel. It explains how disposable cleanroom apparel can help play a role in helping pharmaceutical manufacturers reduce their waste stream while reducing the risk of contamination.

Three Steps to USP H2O Success
Author: Geoff Sheffrin
Sponsored By: OBK Technology Ltd.
USP water systems are highly specific in their requirements. To get there successfully is relatively easy BUT you are dealing with a large number of detailed requirements that MUST work in harmony to produce reliable Purified Water or Water for Injection - cost effectively and with minimum maintenance. Here's how.