EXECUTIVE INTERVIEW – SOLIZE: 3D Data-Based Engineering & Manufacturing to Accelerate Delivery Device Development
Yoshiki Matsuda, Director of SOLIZE, discusses how his company can create new and innovative solutions to accelerate the development of devices and combination products built thereon.
Pnina Fishman, PhD, reports that the A3AR adenosine receptor, expressed in the lungs, liver, brain, aorta, testis, and heart, may hold promise as both a therapeutic target and as a biological predictive marker.
SPECIAL FEATURE – Outsourcing Formulation & Manufacturing Development: Using Data & Unique Approaches to Solve Solubility Issues, Target Profiles & Customize Products
Contributor Cindy H. Dubin finds that CMOs are embracing development projects in an effort to establish longer-lasting partnerships with their pharma and biotech clients. These contract developers are deploying innovative techniques aimed at improving solubility and fast-tracking products to market.
LIPID-BASED DELIVERY SYSTEMS – New Approaches for Macromolecule Oral Delivery, Abuse Deterrence & Bioavailability Enhancement
Julien Meissonnier reviews the development of a broad range of advanced oral drug delivery technologies, including a toolkit of technologies based upon the broad application of lipid-based drug delivery systems for optimum solubility enhancement.
Marshall Crew, PhD, indicates that while it may seem as if today’s technologies for dealing with solubilization challenges have emerged throughout the past 2 decades, their maturation took over a century, and this process itself is an interesting study in innovation diffusion.
Mohit Kumar, MPharm, Parijat Pandey, and Harish Dureja, PhD, develop and characterize a single-unit, floating controlled drug delivery system of famotidine hydrochloride using a blend of natural polymer and synthetic polymer along with a gas-generating agent by applying Box-Behnken design.
PARTICLE AGGREGATION ANALYSIS – Biologics & Particulates: Identification & Control in the Product Lifecycle
Zabin Younes says that traditional tools, such as SEC and DSC, have been used in formulation screening; however, to ensure a control of particulate counts, it is important to use the full range of tools to ensure all types and sizes of particles and aggregates are assessed and accounted.
ABSTRACT Novel nanoscale particles (Vaults) as first described in 1986, exist in the multiples of thousands in most eukaryotic cells. Having an intricate shape composed…
INTRODUCTION Soft gelatin capsules (softgels) continue to be the oral solid dosage form preferred by consumers.1 Understandably, as they are easy to swallow and digest,…
EXECUTIVE INTERVIEW – Croda: Understanding & Addressing the Purity Needs of the Pharmaceutical Market
Dr. Andrew Kaziska, Health Care Applications Manager at Croda Inc, discusses his company’s Super Refining technology and the benefits of excipient purity in drug formulations.
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….