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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, PhD
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.
Authors: Matthew Ferguson
Publish Date: 15-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.
Authors: Cameron Kadleck, Matthew Ferguson, Jimmy Beaty
Publish Date: 08-Oct-2020

Lonza Solid Form Services

At Lonza Solid Form Services, we have defined work flows to assess and select solid forms in a cost and time efficient manner that meets the needs of each individual program. To find out more, read our technical brief.
Publish Date: 30-Sep-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.
Authors: Christian Dowdeswell
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

Advancing active pharmaceutical ingredients (APIs) through the drug product-development lifecycle is challenging.  Development timelines are tight, therefore it’s crucial to determine early in the process if an API is a viable candidate for progression in the clinic. A key tool that has emerged to address rapidly advancing a molecule to the clinic is precision powder-in-capsule micro-dosing. This paper describes (1) the use of precision micro-dosing to prepare powder API-in-capsule (PIC); (2) dosage forms for oral or pulmonary administration; (3) rapid evaluation of an API in Phase I and II; and (4) case studies of precision micro-dosing. To learn more, read our paper.
Authors: Mark Cappucci
Publish Date: 14-Sep-2020

Solid Form Screening and its Role in Drug Development

In this presentation, learn about the underlying fundamentals of polymorphism, hydrates/solvates, salts, and cocrystals; regulatory requirements; and the importance of solid form screening and characterization in both drug substance and drug product development.  To learn more, download our webinar slides.
Authors: Michael Grass, PhD
Publish Date: 10-Sep-2020

Lonza Solid Form Screening and its Role in Drug Development - On-demand

Watch our on-demand webinar to learn about the underlying fundamentals of polymorphism, hydrates/solvates, salts, and cocrystals; regulatory requirements; and the importance of solid form screening and characterization in both drug substance and drug product development. To hear more, watch our on-demand webinar.
Authors: Michael Grass, PhD
Publish Date: 10-Sep-2020

Formulation and Development Approaches for Amorphous Solid Dispersion Drug Products - On-demand

This on-demand webinar provides guidance on general strategies for developing a successful amorphous solid dispersion formulation - from formulation intermediates to final dosage forms. The presentation also covers screening, stability and manufacture, including strategies for incorporating amorphous solid dispersions into immediate release tablets. To learn more, view the on-demand webinar.
Authors: Jesus Soto, Aaron Stewart
Publish Date: 03-Sep-2020