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Liquid-Filled Capsules for Highly Potent Drug Compounds

Highly potent active pharmaceutical ingredients (HPAPIs) are an increasing portion of pharma and biotech pipelines. Because of their highly potent nature and the low dose for these compounds, occupational exposure and dose uniformity can be make the development pathway more difficult.  Read our Executive Summary to learn more about how liquid-filled hard capsules can improve a HPAPI compound’s development pathway.
Authors: Alyn McNaughton
Publish Date: 27-Oct-2020

Rapid Fire Presentation: Methanol-Assisted Secondary Drying to Accelerate Residual-Solvent Removal in Spray-Dried Polymers

In this presentation, we (1) identify the challenges associated with secondary drying of spray dried materials; (2) describe the experimental setup used to conduct methanol-assisted secondary drying; and (3) define the circumstances where methanol-assisted secondary drying can be beneficial to spray dried dispersion manufacturing.  To learn more, please download our slides.
Publish Date: 27-Oct-2020

Model-based Optimisation of Mixed Solvent Systems for Spray Drying

Spray drying is a common and effective approach to enhance the bioavailability of low-solubility small molecules. Jonathan Cape, Kimberly Shepard and Michael Morgen examine different approaches to spray drying to optimise drug production and quality.
Publish Date: 26-Oct-2020

Solid Form Screening: A Key Drug Development Step

Solid form selection is critical to a streamlined drug product development program and can ensure that options for drug product and drug substance process are considered early in development, leading to optimized solutions. This executive summary describes (1) Lonza methodology for solid form selection; (2) the importance of solid form selection on drug product and drug substance process selection; and (3) solid form selection case studies.
Authors: Michael Grass
Publish Date: 16-Oct-2020

Particle Engineering For Inhalation Drug Delivery

Inhalation-based drug products play a critical role in addressing the rising incidence of respiratory diseases around the globe.  Particle engineered-based formulations are key in designing and developing effective dry powder inhaler (DPI)-based drugs.  This article discusses key parameters for choosing the right particle engineering approach to meet DPI target product profiles.
Publish Date: 15-Oct-2020

Article: The Rise of HPAPI Molecules

In development and manufacture of innovative molecules and products, particularly with highly potent API (HPAPI), proper containment and handling capabilities are critical to success. Maurits Janssen explains how partnering with a CDMO can provide the resources and expertise to small, emerging, and even virtual biotech companies that lack the in-house capabilities to manufacture these molecules on a large scale.
Authors: Maurits Janssen
Publish Date: 09-Oct-2020

Engineering Approaches to Respiratory Drug Delivery: Mannitol Case Study

Spray drying and jet milling are commercially viable engineering processes for the development of respirable drug products. This summary presents a case study that explores the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol. To learn more, please read our executive summary.
Publish Date: 08-Oct-2020

Lonza's Continuing Investment in High Potency API: An Interview with Christian Dowdeswell

Highly potent compounds are growing at double the rate of other small molecule active ingredients due to the industry’s investment in increasingly targeted and more effective therapies. The increasing demand for highly potent compounds is concentrated among three therapeutic areas – chief among these is oncology, along with diabetes and autoimmune diseases. To learn more, read the interview.
Publish Date: 18-Sep-2020

The Rise of HPAPI Molecules - Trends in Highly Potent API Manufacturing

Highly potent active pharmaceutical ingredients are increasing in pharma pipelines.  Lonza offers all HPAPI-related expertise to support your product development from concept to commercial use in an integrated manner. To learn more, read our whitepaper.
Authors: Maurits Janssen
Publish Date: 16-Sep-2020

Precision Powder-In-Capsule Micro-Dosing Accelerates Drug Product Development

Precision Micro-Dosing Accelerates Drug Product Development Precision micro-dosing approaches are invaluable to quickly get formulations to the clinic, saving time, money, and limiting the use of API. Lonza’s Xcelodose® Precision Micro-dosing System can help accomplish these goals. To learn more, read our executive summary.
Authors: Mark Cappucci
Publish Date: 14-Sep-2020