QbD-Based Formulation Services-The DPT Labs Approach
Sponsored By: DPT Laboratories
This paper describes the approach and benefits of using DPT Labs' QbD Formulation service and follows the previous paper in our Thought Leadership Series, "What is QbD and Why Should You Care?"

Method Validation for Quantitative Heavy Metals Testing
Author: Tania Russell and Nikki Schopp
Sponsored By: SGS Life Science Services
The proposed USP <232> and <233> changes will require ICP and ICP-MS expertise, instrument set-up, the system for sample introduction, and plasma discharge. All are integral aspects of successful method validation.

A Proactive Approach To Asset Management: Millions can be made by using a web-based asset management solution to keep track of idle pharmaceutical equipment and redeploy it elsewhere in the company
Author: Cindy Dubin
Sponsored By: EquipNet
A proactive approach to asset management is empowering life-science companies to get control of their manufacturing and laboratory environments. By identifying idle and surplus equipment, and subsequently selling that equipment, these organizations are able to fund new capital purchases, recoup money from capital that they already own, and uncover value from equipment that would otherwise continue to take up precious space in their facility. An asset management program that incorporates equipment redeployment, secondary market sales, online auctions, and even recycling can garner millions of dollars.

Improving Product Quality with Risk Assessment Tools
Author: Brenda Percy
Sponsored By: EtQ Inc
With the product lifecycle moving so fast, many organizations may ask the question, "How can we effectively measure quality?" The answer is risk management. Learn the elements of risk management and how they help to identify, prevent, and mitigate risk throughout an organization.

EMC^® DOCUMENTUM^® QUALITY AND MANUFACTURING
Author: EMC Life Sciences
Sponsored By: EMC Life Sciences
Centrally control quality documentation to streamline processes and support compliance.

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 needs 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.

Gut Microbes and Medicines: How the GI environment impacts drug metabolism
Author: Oliver Grundmann, PhD
Sponsored By: University of Florida Pharmaceutical Chemistry
A wide range of factors determines the safety and efficacy of a drug. For example, microorganisms in the gastrointestinal tract impact how a drug gets metabolized. Topics in this discussion include: How variable is the microbial composition in the human gut? What models are being used to study the gut microbiome and its influences on drug metabolism? What role does pre-systemic drug metabolism play in the effectiveness or also in the toxicity of a drug (and impact on drug formulation)?

"5 Rules of Sensor Placement in Validation/Mapping Applications
Sponsored By: Vaisala
New Good Distribution Practice (GDP) regulations explicitly assign responsibility for compliance to the entire distribution network. This means that a large number of previously unregulated entities must now secure their portion of the cool chain by performing mapping studies. This has created a demand for clear and concise guidance to support mapping studies, and at the forefront of this demand are the two questions: 1) where to place sensors and 2) how many sensors to use. To meet this demand we developed the "5 Rules of Sensor Placement." Using a heuristic approach, these rules can guide a new mapping practitioner to a reasoned rationale for sensor placement in mapping studies and supply much needed guidance in this basic and critical validation activity.

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.

Good Practices for Calibrating and Managing Sensing Instruments Used in GxP-Compliant Applications
Sponsored By: Vaisala
Created by Vaisala's calibration experts, this eBook contains great information for new and expert metrologists managing instruments in GxP-compliant environments.

Functional Surfaces To Control Surface-Biomolecule Interaction
Authors: Dr. Heinrich Jehle
Sponsored By: Greiner Bio-One GmbH
The toolbox material science containing several pathways for selective surface functionalization, enables the development of novel biological assays and applications. These new functional materials give the chance to overcome existing limitations in biotechnology. Cell-based assays, microarrays as well as optimized protein crystallization platforms are exemplified.

Managing Risk and Driving Profitability with Today's Process Analytical Technologies in the Pharmaceutical Industry
Sponsored By: Waters Corporation
Over the past few decades, terms such as lean six sigma, total quality management, and continuous improvement strategy have become increasingly common in discussions of manufacturing plans. These techniques have one goal in common: to develop processes that maximize productivity and consistency and minimize risk to workers, consumers, and to the company.

Evaluation of a New Co-Processed Excipient "SmartEx" for Orally-Disintegration Tablets
Authors:: Sakae Obara
Sponsored By: Shin-Etsu Chemical Co., Ltd.
A new co-processed excipient "SmartEx" has been developed for orally-disintegration tablets. The white paper contains results of studies on its physical properties, tablet performance, and stability.

Stability Evaluation of Amorphous Solid Dispersions (ASDs) of Felodipine (FLD) during Storage and Biphasic Dissolution
Author: L. Sarode, S. Malekar, C. Cote, and D. R. Worthen
Sponsored By: Nisso America
The purpose: to compare HPC-SSL versus PVP-VA as pharmaceutical formulation excipients for the production of hot melt mixed ASDs of FLD.

Evaluating Coder Technologies for Pharmaceutical Applications
Sponsored By: Videojet Technologies Inc.
Now that the deadlines for compliance are clear, pharmaceutical companies are fast transitioning from planning to implementation. And while serialization is a complex topic, working with a qualified coding provider can help you take one challenge off the agenda. Serialization success starts with a high-quality code on your packaging.

Cleaning Validation for Pharmaceutical Manufacturing
Sponsored By: Alconox
Cleaning validation is a necessary and time consuming part of manufacturing pharmaceuticals. The validation process can be expedited and cost of validation can be lowered if the cleaner supplier can provide support, allowing for pharmaceuticals to get to market faster and at a lower cost. This paper outlines the basics of cleaning validation, as well as discussing the kinds of support services you should seek from your supplier of critical cleaning products in order to optimize your cleaning validation process.