January/February 2014

COVER

RESIDUAL IMPURITIES - Developing & Validating an Efficient Method to Determine Residuals of Hormone Products by LC-MS After Cleaning of Equipment

Geoff Carr, PhD, describes the benefits of LC-MS and presents an effective method using this technology to determine the potential residual amount of eight active ingredients used in oral contraceptive tablets after cleaning equipment used in their manufacture.

FEATURES

RESIDUAL IMPURITIES - Developing & Validating an Efficient Method to Determine Residuals of Hormone Products by LC-MS After Cleaning of Equipment

Geoff Carr, PhD, describes the benefits of LC-MS and presents an effective method using this technology to determine the potential residual amount of eight active ingredients used in oral contraceptive tablets after cleaning equipment used in their manufacture.

LYOPHILIZATION PACKAGING - Packaging Freeze-Dried Substances - There Are Options

Thomas Otto believes a specialized CDMO can provide efficient solutions to the many challenges surrounding lyophilized substances. But it should be ascertained they have packaging, manufacturing, and lyophilization expertise.

PREFILLABLE SYRINGE TECHNOLOGY - BD Neopak - Delivering the Next Generation in Glass Prefillable Syringes

Justin M. Wright, PhD, and Herve Soukiassian highlight significant development and commercial manufacturing investments in glass PFS container technology for the biotech industry with three key areas of focus: reducing overall variability, reducing SbVPs, and increasing glass strength and durability performance.

BUSINESS DEVELOPMENT - Product Versus Service Business

John A. Bermingham discusses running a service business for the first time after having led products businesses his entire career, and quickly begins to see the differences.

DATA MANAGEMENT - Taking Regulated Content to the Cloud

Martin Magazzolo believes the cloud presents a strong alternative to costly internal solutions when managing content for R&D, allowing companies to shift their focus to innovation.

ROUNDTABLE DISCUSSION: Reformulating Opioids to Deter Abuse

Contributor Cindy H. Dubin talks with some leading Specialty Pharma companies to find out how they are formulating technologies to deter the growing problem of opioid abuse.

EXECUTIVE INTERVIEW - EMD Millipore: Enhancing the Bioavailability of Active Pharmaceutical Ingredients

Drug Development Executive: Steffen Denzinger, Head of Portfolio Development at EMD Millipore, talks about bioavailability challenges and how EMD Millipore’s formulation portfolio and expertise are helping the pharmaceutical industry achieve maximum efficacy with APIs.

ADVANCED DELIVERY DEVICES - Engineering the Perfect Click for Drug Delivery Devices

Chris Hurlstone says device developers - whether human factors experts or industrial designers, mechanical engineers, or risk analysis teams - know engineering of the click is critical, yet this aspect of device design, like many others, is frequently not given the attention it deserves.

BIOAVAILABILITY ENHANCEMENT - A New Year for Solubility Enhancement

Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., continues his multiple-part series discussing today’s most challenging issues in solubility.

EXECUTIVE INTERVIEW - Battelle: Innovation in Drug Delivery Through Integrated Science & Engineering

Drug Development Executive: Amy Heintz, PhD, Senior Research Scientist at Battelle, speaks about the company’s relationship with customers and the importance of integrating device design, formulation, and human factors in the development of safe and efficient drug delivery solutions.

MANAGEMENT INSIGHT - Six Reasons Why the Affordable Care Act May Be a Bad-Tasting Medicine That Could Heal Our Industry

Derek Hennecke says that whether you love the Affordable Care Act (ACA) or abhor it, the fact is, there are billions of dollars of government money in play and some industries are going to benefit tremendously.