Jim Huang, PhD, and Edward Orton, PhD, say it is critically important CROs or CDMOs that support discovery and preclinical research have the requisite preformulation, formulation, and biopharmaceutics expertise as well as the proprietary methodologies to develop formulations from small quantities of drug candidates for different routes of administration.
CHARACTERIZATION CORNER – From Dilute Sample to Clinically Representative Formulation: Analyzing the Higher Order Structure of mAbs Over a Wide Dynamic Range
Jeff Zonderman explains how the characterization of mAbs at high concentration in clinically representative formulations, without the need for dilution or concern for interference from a formulation buffer’s excipient, is vital.
Contributor Cindy H. Dubin speaks with several leading analytical labs and CDMOs to review their technologies, services, and new strategies to operate in this ever-changing environment.
Jim Huang, PhD, discusses how a sophisticated drug delivery approach involves collaboration, technical experience, and years of working knowledge in drug development at different stages of the process.
TRANSLATIONAL PHARMACEUTICS – Accelerating Early-Stage Drug Development With Integrated CDMO & CRO Services
Peter Scholes, PhD, describes the current challenges and questions faced by drug developers in accelerating molecules to POC and developing optimized and scalable drug products for patient trials.
CLINICAL ANALYTICS SOLUTIONS – Reducing Clinical Cost Budget Variations With State-of-the-Art Data Lifecycle Management Solutions
Srini Anandakumar explores an approach for how sponsor’s operational data, coupled with syndicated data and Real World Evidence data, can enable predictive analytics on clinical cost drivers using a clinical big data and Machine Learning-enabled platform.
Cheryl Johnson says the study of E&L has been evolving for many years, and as pharmaceutical manufacturers, packaging vendors, and regulatory agencies gain more knowledge of extractable compounds, the scope of E&L guidelines grows with it.
TOPICAL DELIVERY – Novel Approaches to Topical Antibiotics Promise Innovation in the Treatment of Acne & Rosacea
Scott Herron, MD, PhD, indicates dermatologists and their patients need a better way to deliver antibiotics effectively without contributing to the resistance problem, and an ideal solution might be a new topical antibiotic formulation.
CLINICAL TRIALS – Spotlight on Quality in Study Startup: Automated Workflows Encourage Upfront Planning & Downstream Improvements in the eTMF
Elvin Thalund, MS, and Craig Morgan say the emphasis on quality is everywhere, but in particular, the study startup portion of clinical trials is a particular hotspot, as it is pivotal to improving study conduct overall.
EXECUTIVE INTERVIEW – Vetter: Insights on Insourcing Versus Outsourcing in the World of Injectable Manufacturing
Oskar Gold, Vetter’s Senior VP, Key Account Management and Marketing/Corporate Communications, offers his insights on aseptic manufacturing and why careful thought and consideration of different criteria must be applied.
EXCLUSIVE ONLINE CONTENT
EXECUTIVE INTERVIEW – Oasmia Pharmaceutical: Commercializing Technologies While Pursuing the US Market
Julian Aleksov, Executive Chairman of Oasmia Pharmaceutical, discusses his company’s efforts to enter the US market, its strategy to increase commercial adoption, and why it believes its underlying drug delivery system technology is significant not only within the oncology sector, but the entire pharmaceutical industry.
Hywel Williams, PhD, Annabel Igonin, PhD, David Vodak, PhD, and Hassan Benameur, PhD, believe lipophilic salts are being explored in a number of different areas and one interesting application is their potential to boost API loading in lipid formulations.