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.
MANAGEMENT INSIGHT – Ding Dong, Your CRO’s Calling: Lessons From the World’s Largest Direct Marketer Part 4 of a 6-part series on lessons learned from other industries.
Derek G. Hennecke continues with part 4 of his 6-part series on lessons learned from other industries.
EXECUTIVE INTERVIEW – The Contract Diagnostics Organization: Revolutionizing Management for Co-Development of Companion Diagnostics
Mathew W. Moore, PhD, and Philip D. Cotter, PhD, Principals and Co-Founders of ResearchDx, discuss the concept of a CDO and how this new business model stands to impact personalized medicine and revolutionize management of the co-development of companion diagnostics.
Dr. Rod Ray, CEO and Chairman at Bend Research, discusses his company’s approach to difficult drug delivery challenges and the core technologies offered by his company.
EXCLUSIVE ONLINE CONTENT
With several mega cap biopharma companies having their vital manufacturing steps in Chinese facilities, the novel coronavirus (Covid-19) outbreak is putting the complicated global biopharma industry’s supply….
Simply put, a technology transfer is the moving of a product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve project realization…..
Pfizer Inc. and BioNTech SE recently announced the companies have agreed to a letter of intent regarding the co-development and distribution (excluding China) of a….
Exagen Inc. Partners With Sonora Quest Laboratories to Offer AVISE Testing for Patients Suspected of Autoimmune Disease
Exagen Inc. recently announced it has entered into a strategic partnership with Sonora Quest, the nation’s largest integrated…
Tyligand Bioscience and Context Therapeutics LLC recently announced the signing of collaboration agreements for the development, manufacturing, registration and future commercialization of….