April 2014

COVER

ANTIBODY DRUG CONJUGATES - ADC Development Using SMARTag(TM) Technology

Robyn M. Barfield, PhD, and David Rabuka, PhD, say that despite challenges, there has been progress in advancing complex compounds through clinical trials and successfully treating patients, and these bioconjugate compounds include a subset of molecules known as ADCs.

FEATURES

SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Early-Stage Partnerships Are On The Rise

Contributor Cindy H. Dubin asked leading CMOs and CDMOs to describe the value-added services they offer with respect to formulation and manufacturing. Solving challenges of insufficient solubility, poor stability, identifying excipient candidates, and particle design topped their list of offerings.

INTRAORAL DELIVERY - Utilization of Intraoral Administration for Enablement & Enhancement of Drug Delivery – Highlights of Recent Commercial Products

Zhen Yang, PhD, and Yunhui Wu, PhD, highlight several commercialized intraoral formulations from a clinical pharmacokinetic perspective and reveal its mechanism for enablement or enhancement of drug delivery via intraoral administration.

BUCCAL DELIVERY - Dissolvable Film Format Evolves to Buccal Drug Delivery Applications

Scott D. Barnhart indicates the buccal and sublingual oral mucosa will continue to be an area of growing interest for drug delivery as researchers evaluate ways to improve bioavailability, patient compliance, and product lifecycle beyond tablet and injectable formats.

ANTIBODY DRUG CONJUGATES - ADC Development Using SMARTag(TM) Technology

Robyn M. Barfield, PhD, and David Rabuka, PhD, say that despite challenges, there has been progress in advancing complex compounds through clinical trials and successfully treating patients, and these bioconjugate compounds include a subset of molecules known as ADCs.

FIXED-DOSE COMBINATIONS - Fixed-Dose Combination Products – A Review (Part 2 – Analysis)

Tugrul T. Kararli, PhD, MBA, Kurt Sedo, and Josef Bossart, PhD, believe the pharmaceutical industry has been paying increasing attention to the potential of Fixed-Dose Combination products, and in a series of three articles, examine the past, present, and future of these products with the intent of understanding their whats and whys.

DISPOSABLE TECHNOLOGY - Use of Disposable Technology in Clinical Fill & Finish Manufacturing: Benefits & Considerations

Claudia Roth, PhD, reviews not only the benefits of using disposables, but the real-world variables to consider when converting to single-use technology. The pathway begins with the question, why use disposables?

EXECUTIVE INTERVIEW - Array BioPharma: Steadily Moving to Late-Stage Development, Preparing for Commercialization

Executive Summary: Ron Squarer, Chief Executive Officer of Array BioPharma, talks about the company’s pipeline and evolution into a fully integrated, commercial-stage biopharmaceutical company.

EXECUTIVE INTERVIEW - BioCellChallenge: Optimizing the Potential of Intracellular Therapeutic Antibodies

Drug Development Executive: Dr. Laurent Meunier, CEO of BioCellChallenge, discusses the development of a new liposomal formulation allowing the use of intracellular therapeutic antibodies.

BIOAVAILABILITY ENHANCEMENT - Diffusion of Innovation & the Adoption of Solubilization Technologies

Marshall Crew, PhD, says that although diffusion processes of innovative products and services have been studied extensively for nearly 45 years, it seems reasonable that we might learn from others’ observations, and the frameworks they’ve developed to model diffusion of technology for the adoption of bioavailability platforms.

BUSINESS DEVELOPMENT - Traffic Light Decision-Making

All of us have faced decisions in which, if we make the right decision, we are a hero, and if we make the wrong one, we are a bum. This..