Formulation Development
MODIFIED RELEASE – Alternative Strategies for Development of Modified-Release Dosage Forms
Andy Lewis, PhD, discusses a range of available formulation technologies, the challenges in MR formulation development, and the use of a design-space approach with on-demand manufacturing.
COMBINATION PRODUCT DEVELOPMENT – New Horizons in Development to Meet Emerging Demands
Ed Trappler and John A. Merhige, MEM, believe it is no longer sufficient to put a product in a vial, and the future of healthcare products places increasing demands on the industry to provide innovations for delivering combination products.
CHARACTERIZATION CORNER – A New Weapon in Formulation Development
Matt McGann explains how Microfluidic Modulation Spectroscopy is the final addition in the biophysical characterization scientist’s toolkit.
MICROFLUIDIC ENCAPSULATION – Controlling Drug Delivery With PLGA
Richard Gray, MA, discusses the use of polymer microparticles for pharmaceutical applications, including specific examples of polylactic-co-glycolic acid (PLGA) encapsulation.
ON-BODY DELIVERY SYSTEMS – Analysis & Simulation of Injection Volume Accuracy
Christian Riva, MS, presents a case study proving it is possible to have a realistic prediction of the injection volume accuracy of a drug delivery system, even in an early stage of product development, when only a high-level product architecture is available.
EXECUTIVE INTERVIEW – Cambrex: Providing Big Value in the Small Molecule Outsourcing Market
Simon Edwards, President, CDMO Sales & Marketing at Cambrex, discusses the biggest trends in the small molecule outsourcing market.
DATA ANALYTICS – Leveraging Cloud-Based Data & Analytics to Optimize Pharmaceutical Manufacturing
Benzi Mathew explains how recognition is increasing about the powerful impact data and analytics can have on optimizing the manufacturing process and ensuring demand is met every time, all the time.
BIOLOGICS DELIVERY – Enabling Biologic Drug Delivery of Volumes Beyond 1 mL
Megan Lan, MBA, MA, and Patrick Le Gal say delivery system manufacturers need to use methodologies and tools to manage conflicting requirements and to offer delivery solutions that balance performance, robustness, and usability while delivering higher volume or viscosity biologics.
INTRATUMORAL DELIVERY – Arming the Immune System; Turning Cold Tumors Hot
Daniel J. O’Connor believes a trigger mechanism that can turn cold tumors hot can help researchers set their focus on delivering potentially life-saving drugs directly to core of a cancerous tumor.
ON-TARGET DELIVERY – Lipid-Based System Introduces a Novel Approach for an HIV Vaccination
Fabrice Navarro, PhD, summarizes recent disappointing clinical trial results for HIV vaccines and reports on CEA-Leti’s new approach based on engineered lipid nanoparticles that deliver p24 (a viral protein that optimizes the CpG adjuvant’s effect) with pinpoint accuracy.
EXCLUSIVE ONLINE CONTENT
Patient-Derived Tumor Organoid Drug Development Platform Launched
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 Receives US FDA Approval for PF708 to Treat Osteoporosis
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…
Streamlining Drug Development Processes Through the Accenture INTIENT Clinical Platform
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….