April 2018

COVER

SPECIAL FEATURE - Challenging Molecules Drive Developers to Get More Creative With Excipients

Contributor Cindy H. Dubin highlights the techniques various excipient manufacturers are using to develop more innovative and effective ingredients to improve the performance of drug molecules.

FEATURES

GLOBAL REPORT - 2017 Global Drug Delivery & Formulation Report: Part 2, Notable Product Approvals of 2017

In part 2 of this 4-part series, PharmaCircle in collaboration with Drug Development & Delivery, reviews the more interesting individual products approved throughout the past year.

PREFILLED SYRINGES - Prefilled Syringe Automated Inspection & End-Product Testing

Gregory A. Sacha, PhD, introduces the common equipment available for automated inspection and discusses inspection testing methods for prefilled syringes.

MONOCLONAL ANTIBODIES - The Development of Therapeutic Monoclonal Antibody Products: A Comprehensive Guide to CMC Activities From Clone to Clinic

Howard L. Levine, PhD, and Brendan R. Cooney, provide a guide to product development companies, service providers, investors, and analyst as they work their way through the complex and rapidly evolving world of therapeutic monoclonal antibodies.

ORALLY INHALED PRODUCTS - Optimizing the Application of In Vitro Test Methods for the Demonstration of Bioequivalence in Orally Inhaled Products

Mark Copley, MEng, and Anna Sipitanou, MSc, examine the testing strategies demonstrating the BE of OIPs, their relevance, and the submission approaches outlined by the FDA and EMA.

FDA UPDATE - The FDA's New Drug Approval Process: Development & Premarket Applications

Kaiser J. Aziz, PhD, in this latest FDA update, emphasizes quality system approaches to the development and availability of new drug information presented in the proposed labeling of the product.

EXECUTIVE INTERVIEW - MilliporeSigma: Accelerating the Development & Manufacture of Gene Therapies, Immunotherapies & Viral Vaccines

Dave Backer, Head of Virus & Gene Therapy Strategic Initiatives at MilliporeSigma, talks about his company’s expanding GMP capacity to speed development and manufacture of gene therapies, immunotherapies, and viral vaccines.

CLINICAL TRIALS - Inconsistencies Prevalent in Study Start-Up

Craig Morgan believes as stakeholders are increasingly aware that better study start-up (encompassing the activities associated with site identification, feasibility assessment, selection, and activation) processes are linked to shorter clinical timelines, the emphasis has been shifting in that direction.

EPR SPECTROSCOPY - Bringing EPR to a Wider World: Biological ROS & RNS Detection

Kalina Ranguelova, PhD, demonstrates how the latest digital and microwave technologies in benchtop EPR instrumentation is giving researchers new insight into ROS and free radicals that may shape the future development of more effective treatments of disease.