Derek G. Hennecke concludes his 6-part series on lessons learned from other industries.
Dr. Colin Minchom, VP of Hovione’s Particle Design business unit, discusses how the company is evolving and adapting in the current market and reviews its new Particle Design offering.
LYOPHILIZATION – Making Formulations More Efficient Using the Freeze-Dry Microscopy Pre-Lyophilization Method
Jeffrey McGinn says to minimize cost and streamline this process, many companies developing new parenterals are finding it in their best interest to optimize their lyophilization cycles by looking at pre-lyophilization methods such as freeze-dry microscopy.
BIOAVAILABILITY ENHANCEMENT – Overcoming Poorly Soluble Pharmaceutical Formulations With Hot Melt Extrusion
INTRODUCTION Solubility is an essential characteristic of active pharmaceutical ingredients (APIs), with profound effects on process and clinical development, formulation, and commercialization. Higher-solubility drugs dissolve…
FORMULATION DEVELOPMENT – Recombinant Human Albumin: Delivering the Future of Type 2 Diabetes Medication
Mark Perkins, PhD, discusses the application of human serum albumin as a half-life extension technology for GLP-1 therapeutics and how further developments in recombinant human albumin technology may further change the dosing paradigm.
ANALYTICAL TESTING – Analytical Tools & Techniques in Hot Melt Extrusion & Case Studies on Formulation Development & Process Scale-Up
Tony Listro, MS, MBA; Mike Borek, Michael Crowley, PhD, MBA; and Kathrin Nollenberger, PhD; review how a stepwise approach to characterizing formulation prototypes using microscopy, thermal analysis, spectroscopy, nonsink dissolution testing, and chromatography can be used to rapidly rank order formulations.
EXECUTIVE INTERVIEW – DPT Laboratories: Providing Solutions to Sterile & Non-Sterile Development & Manufacturing of Semi-Solid & Liquid Dosage Forms
Paul Johnson, DPT Group President & Chief Operating Officer, talks about the consistent growth and success of DPT, its expansion in the sterile arena, and plans for the future.
PACKAGING – Trends in Pharmaceutical Primary Packaging for Injectables – Solutions for New Challenges
Claudia Petersen forecasts that primary packaging suppliers will assume an increasing number of production steps relating to closure preparation for the fill & finish process, and as a result, they will evolve from component providers to system suppliers and product development project partners.
MANAGEMENT INSIGHT – Whiteboard Walls & Open Doors: Creating an Environment for Pharmaceutical Innovation
Derek G. Hennecke continues with part 5 of his 6-part series on lessons learned from other industries.
Andrew Loxley, PhD, and Brett Braker say many of the processes used to manufacture products within the pharmaceutical industry are unique to the particular product; however, there are also processes that have been borrowed and adapted from other manufacturing industries and successfully employed in the development of pharmaceutical products. One such example is injection molding.
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