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.
PACKAGING SOLUTIONS – Dura Coat Combiseals – An Optimal Solution for Cartridge Applications
Carina Van Eester, MSCE, believes with state-of-the-art medicines, it is essential that drug manufacturers can rely on appropriate sealing solutions that provide the best possible protection for their products.
WEARABLE DEVICES – Wearable Drug Delivery Applications: Considerations for Adhesive Material Selection & Wear Testing
Neal Carty, PhD, MBA, and Deepak Prakash, MS, MBA, discuss the broader healthcare and digital health landscape behind wearable device developments and provide a brief overview of two types of wearable applications — insulin pump therapy/continuous glucose monitoring (CGM) systems and wearable drug injectors.
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.
SPECIAL FEATURE – Injection Devices: Wearables, Connectivity & Patient-Centric Designs Empower Self-Administration
Contributor Cindy H. Dubin highlights the innovation in injection devices – from wearables to connectivity to varied dose administration – that have occurred in the past year.
DEVICE DESIGN – Autoinjector Design Adjustment to Control Needle Insertion & Initial Injection Speed – Could This Positively Impact Drug Delivery?
Pascal Dugand, Thomas Megard, and Séverine Duband explain how controlling the needle insertion speed can reduce the shock on the prefilled syringe, which can reduce the risk of glass breakage, and will allow a smooth transition to syringe emptying.
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.
EXCLUSIVE ONLINE CONTENT
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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.
Credence MedSystems Awarded Gates Foundation Grant to Develop Dual Chamber Drug Delivery Device
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Pfenex Receives US FDA Approval for PF708 to Treat Osteoporosis
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Streamlining Drug Development Processes Through the Accenture INTIENT Clinical Platform
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Gerresheimer Opens US Glass Innovation & Technology Center
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FORMULATION FORUM – Rational Design & Development of Long-Acting Injectable Dosage Forms
Due to the advantages of parenteral sustained-release drug delivery (also known as long-acting injectables, LAIs) different types of sustained-release injectable delivery systems have been….
Cue Biopharma Doses First Patient in Clinical Trial
Cue Biopharma, Inc. recently announced it dosed the first patient in a Phase 1 clinical trial of CUE-101 at Washington University, Alvin J. Siteman Cancer Center, St. Louis, Missouri for the treatment of….
VivaLNK Delivers Continuomics Using Wearable Medical Sensors
VivaLNK, a leading provider of connected healthcare solutions, is improving clinical trials with continuomics by using wearable medical sensors for….
