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.

Using Raman Chemical Imaging to Analyze Inhaled Combination Therapies
Author: Dr. Oksana Olkhovyk
Sponsored By: Gateway Analytical
This white paper discusses using Raman Chemical Imaging as method to analyze dry powder formulations containing multiple active ingredients in order to obtain important data about the aerosolization behavior that was previously unavailable. This analysis offers developers new opportunities to optimize the formulations and the delivery devices for combination therapies.

Successfully Auditing a Contract Lab
Sponsored By: Charles River Labs
An auditor is entitled to determine the scope of its own audit and surely quality personnel have the best intentions when developing paper-based questionnaires, but auditing activities are not a one-size-fits-all exercise. With risk assessment being at the forefront of the FDA’s focus, more supplier evaluations should be incorporating risk at the level of the audit process.

Mixing Technologies in the Pharmaceutical & Medical Industries
Author: Christine Banaszek
Sponsored By: Charles Ross & Son
This white paper presents an overview of mixing technologies implemented across many of today’s highly competitive pharmaceutical and medical industries, as well as new equipment designs that are increasingly being recognized as potential solutions to prevailing mixing challenges. Mixing applications falling within the broad spectrum of mass produced pharmaceutical goods and medical devices are too many and complex to discuss in detail; hence this paper will touch on a few general classifications as well as a few examples within that mixing category. Phase and viscosity are used as bases for classification.

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.

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).

Graceful Scale-Up of Mixing Systems
Author: Christine Banaszek
Sponsored By: Charles Ross & Son
When acquiring a process that involves one or several mixing steps, foresight for scale-up or expansion remains to be a subtle but important factor for long-term success. As production requirements grow, your ability to shift gears smoothly, quickly, and efficiently is critical because it can spell the difference between an economical transition and a financial disaster.

Three Steps to USP H2O Success
Author: Geoff Sheffrin
Sponsored By: OBK Technology
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.

Method Development for Impurity Analysis
Author: Margaret Maziarz
Sponsored By: Waters
 The ACQUITY QDa mass detector aids in the development of efficient and robust screening methods by minimizing the need for standard runs to confirm the identity of peaks by retention time.

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.

How to Prepare for the ICH Q3D Elemental Impurities Guideline
Authors: Janeen Skutnik, NSF Pharma Biotech, part of NSF Health Sciences
Sponsored By: NSF Pharma Biotech
The upcoming implementation of the International Conference on Harmonisation’s ICH Q3D Guideline for Elemental Impurities and the United States Pharmacopeia (USP)’s General Chapters for Elemental Impurities has triggered its fair share of concern and uncertainty. Learn how to best prepare for the ICH Q3D Elemental Impurities Guideline.

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.