Drug Development Executive: Vincent D. Antle, PhD, Senior Director of Technical Operations, and James D. Pipkin, PhD, Senior Director, New Product Development talk about how the company works closely with pharmaceutical and biotechnology companies offering drug delivery solutions that significantly improve stability, solubility, bioavailability, safety, and dosing of APIs.
Edward T. Maggio, PhD, examines how alkylsaccharides offer exciting prospects for novel formulations, providing non-invasive delivery, stabilization, and immunogenicity reduction for biotherapeutic products, resulting in broader patient acceptance and compliance and an increase in their acceptance as viable commercial pharmaceuticals.
Jeffrey Bacha, MBA, says glioblastoma is one of the most common and fatal brain cancers, and new therapies to treat this disease are urgently needed. New approaches, such as vaccines and immunotherapies, have promising results, and to be most effective, will need to be used in combination with a chemotherapeutic.
Drug Development Executive: Amit Patel, President of Capsugel’s Dosage Form Solutions business unit, speaks about the formulation challenges facing the industry and the increasing pressure on companies to remain competitive in today’s dynamic marketplace.
Mark Perkins, PhD, reviews some of the important factors involved, and highlights the advantages of including recombinant human albumin to stabilize protein therapeutics with reference to a recent case study.
BIOAVAILABILITY ENHANCEMENT – Navigating a Broad Spectrum of Solubilization Technologies: Part I of III
In the past two columns, The Second Quadrant focused on excipients and the roles they play in the quest to overcome bioavailability challenges of poorly…
Stefan Hellbardt, PhD, and Degenhard Marx, PhD, focus their review on the trends in topical skin medication, the impact on primary packaging, and possible dispensing solutions.
SPECIAL FEATURE – Transdermal, Topical & Subcutaneous Drug Delivery: Extending Pipelines & Improving Self-Administration
Contributor Cindy H. Dubin explores how the movement of home care and self- administration is pushing the development of this growing sector in drug delivery.
In June’s edition of The Second Quadrant, we heard from leading excipient providers about challenges faced directly related to formulating with excipients for greater bioavailability.…
FORMULATION DEVELOPMENT – Amorphous Dispersion Formulation Development: Phase-Appropriate Integrated Approaches to Optimizing Performance, Manufacturability, Stability & Dosage Form
John Baumann, Dan Dobry, and Rod Ray, PhD, review the development and use of amorphous SDDs and the testing methodologies used to optimize the formulation and spray-drying process for performance, manufacturability, stability, and incorporation into final dosage forms.
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….