EXECUTIVE INTERVIEW – Accera, Inc: Discovering Breakthroughs in Treating Central Nervous System Disorders
Holger Kunze, CEO of Accera, discusses the company’s novel approach to treating AD by addressing cerebral hypometabolism.
BIOAVAILABILITY ENHANCEMENT – Addressing Solubility Challenges: Using Effective Technology & Problem-Solving for Delivery Solutions
Rod Ray, PhD, reviews his spray-dried dispersion (SDD) technology, which is recognized as a reliable solution to oral bioavailability challenges because of its proven performance, predictable long-term stability, and excellent manufacturability.
EXECUTIVE INTERVIEW – Caisson Biotech: Innovatio in Drug Delivery Using a Naturally Occurring Sugar Molecule
Thomas Harlan, CEO of Caisson, discusses how his company is improving the quality and delivery of numerous medications, making life easier for patients, and offering new ways for companies to enhance their drug pipeline.
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.
FORMULATION DEVELOPMENT – Deuterium Modification as a New Branch of Medicinal Chemistry to Develop Novel, Highly Differentiated Drugs
Philip Graham, PhD; Julie Liu, PhD; and David Turnquist, MBA; show that deuterium modification may be used broadly to improve upon previously known compounds or their analogs, in turn offering potential benefits in a wide range of therapeutic areas.
Johannes Wohlrab, MD; Alexandra Goebel, PhD; Dieter Scherer, PhD; Debra Bingham, and Reinhard H.H. Neubert, PhD, develop a colloidal preparation, a microemulsion, that meets the specific conditions for penetration of the psoriatic skin and achieves the required bioavailability of the drug in the underlying tissue, which cannot be achieved by conventional formulations.
THERAPEUTIC FOCUS – Drug Development for the Management of Type 2 Diabetes – Glucose Control Is No Longer Enough
Senior Industry Analyst Debbie Toscano reports the trend in diabetes drug development is moving away from simply controlling blood glucose toward addressing the other important risk factors and comorbidities, primarily obesity and cardiovascular disease.
Srikanth Kakumanu, PhD, and Avi Schroeder, PhD, describe a novel technology capable of efficiently producing nanoliposome formulations at the bench or in a pilot plant, eliminating the need to heat the lipids or dissolve them in a co-solvent during the formulation process.
DRUG DELIVERY – Tunable Half-Life Extension Based on Recombinant Albumin – Tailoring Pharmaceuticals to Specific Medical Needs
Mark Perkins, PhD, reviews the development of a tunable half-life technology to serve as a flexible drug delivery platform designed to enable manufacturers to tailor protein or peptide half-lives to specific medical needs.
FORMULATION DEVELOPMENT – Next-Generation PEGylation Enables Reduced Immunoreactivity of PEG-Protein Conjugates
Merry R. Sherman, PhD; Mark G.P. Saifer, PhD; L. David Williams, PhD; Shawnya J. Michaels, MS; and Monika A. Sobczyk, MS; illustrate the close parallels between the results of Armstrong et al with respect to anti-PEG antibodies detected in sera of ALL patients treated with mPEG-asparaginase and the results reported by Sundy et al based on the Phase III clinical trials of mPEG-uricase in patients with RCG
EXCLUSIVE ONLINE CONTENT
Crown Bioscience recently announced the launch of a new tumor organoid drug development platform with the potential to significantly improve the……
White Paper: Control of Beta-Glucans & Endotoxin in High Purity Sucrose for Biopharmaceutical Applications
This white paper discusses a Quality by Design (QbD) scenario that allows end users to rationally select the well characterized excipients during biopharmaceutical development and develop a control strategy for biologic drug products.
White Paper: High Purity Low Endotoxin Arginine: Applications in Biopharmaceutical Processing & Biotherapeutic Stabilization
This white paper discusses arginine, also known as L-arginine (symbol Arg or R), a basic amino acid widely used in biopharmaceutical processing and stabilization of biotherapeutics.
Pfenex Inc. recently announced the US FDA has approved the new drug application (NDA) for PF708 submitted under the 505(b)(2) regulatory pathway, with…
To facilitate the demand for this new world order, we’ve unveiled the Accenture INTIENT Clinical platform. It helps companies run faster clinical trials with better transparency and….