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Highly Potent Active Pharmaceutical Ingredients (HPAPIs)

With the pharmaceutical industry's focus on oncology and more targeted therapies, the number of highly potent active pharmaceutical ingredients (HPAPIs) in development continues to increase. as does the demand for HPAPI manufacturing capacity. As described in this technical brief, Lonza has more than 20 years experience in the manufacture and handling of HPAPIs. Our expertise, capabilities, manufacturing innovation, and integrated service options are described. To learn more, please read our technical brief.
Publish Date: 05-May-2020

HPAPI Drug Manufacturing Trends

Maurits Janssen, Senior Director, Head of Commercial Development, API Development & Manufacturing, reviews the latest trends in the high-potency market and the critical role CDMOs like Lonza play in accelerating the development of HPAPI drug products.
Authors: Dr. Maurits Janssen
Publish Date: 05-May-2020

Lipid-Based Formulation Technology

Lipid-based formulations (LBF) - including use of lipid excipients, solvents, cosolvents in liquid, semi-solid, or solid formats - are key approaches for improving solubility and bioavailability. This technical brief reviews Lonza's extensive LBF expertise, using liquid-filled hard capsules, soft gels, and lipid multiparticulates to support projects from early design stages through commercialization. To learn more, please see our technical brief.
Publish Date: 05-May-2020

Particle-Size Engineering Through Micronization

Stability, flowability, dissolution rate, and bioavailability (BA) are all critical performance parameters affected by particle-size distribution. As part of our integrated product development services, Lonza offers premier particle engineering capabilities through micronization, from early-stage design through scale-up to commercial quantities. To learn more, please see our technical brief.
Publish Date: 05-May-2020

Lipid-Based Formulations for Early Stage Clinical Trials

Annabel Igonin and Jenifer Mains, Senior Managers, Pharmaceutical Formulation Development, Product Development, analyze the potential benefits and applications of lipid-based formulations and how they may reduce timelines to clinical trials.
Authors: Annabel Igonin, Jenifer Mains
Publish Date: 01-May-2020

DPI Formulation Development and Manufacturing

The respiratory system provides an attractive drug-absorption target to treat local and systemic diseases and is increasingly used to deliver small molecules and biotherapeutics. As described in this technical brief, Lonza has extensive experience in formulation development and manufacturing of respiratory drug-delivery products from proof of concept (POC) to manufacturing of dry-powder inhalation (DPI) formulations. Capabilities include optimized particle engineering, precision micro-dosing, rapid screening, clinically relevant testing, and Good Manufacturing Practice (GMP) production. To learn more, please read our technical brief.
Publish Date: 01-May-2020

Hot-Melt Extrusion Technology

Hot-melt extrusion (HME) is a leading approach to producing amorphous solid dispersions to increase solubility and bioavailability of promising drug compounds. HME technology offers numerous advantages, including well-defined process understanding, small equipment footprint, efficient (continuous) operation, and ready scalability. This technical brief describes Lonza's depth of experience with HME formulation and processing and its broad production capabilities in this important technology area. To learn more, please see our technical brief.
Publish Date: 01-May-2020

Advances in Bioavailability Enhancing Technologies for Poorly Soluble Molecules: in vitro and In Vivo Case Studies

A number of solubility-enhancing technologies are available to formulators to improve the bioavailability of poorly water-soluble molecules. The choice of a technology can be rationally based on an understanding of the physical-chemical properties of the molecule and in vitro measurements to help define the mechanism that is limiting bioavailability. This presentation presents in vitro and in vivo test data to demonstrate this technology-selection methodology. To learn more, please view our presentation.
Authors: Dr. David Lyon
Publish Date: 16-Apr-2020

Drug Product Advancement - A Path Through Development by Powder in Capsule Approach

Using micro-dosing technology and powder-in-capsule (PIC) or powder-in-bottle (PIB) approaches, biopharmaceutical companies can increase speed to clinic, quickly assess their candidate compounds, and remain cost-conscious in early stage development. In this webinar, Lonza experts review best practices PIC and PIB challenges and discuss rapid encapsulation transfer from clinic to commercial scale. To learn more, please view our presentation.
Authors: Mark Cappucci, Alyssa Botta, Rebecca Henry
Publish Date: 14-Apr-2020

Drug Product Advancement Webinar

Using micro-dosing technology and powder-in-capsule (PIC) or powder-in-bottle (PIB) approaches, biopharmaceutical companies can increase speed to clinic, quickly assess their candidate compounds, and remain cost-conscious in early stage development. In this webinar, Lonza experts review best practices PIC and PIB challenges and discuss rapid encapsulation transfer from clinic to commercial scale. To learn more, please view our on-demand webinar.
Authors: Mark Cappucci, Alyssa Botta, Rebecca Henry
Publish Date: 14-Apr-2020