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Chromatography, Purification & Isolation Technologies

For development and supply with novel active pharmaceutical ingredients, a strong partner with a wide portfolio of technologies is advantageous. In this on-demand webinar you will learn which options Lonza can offer you in the field of chromatography and allied downstream technologies.  It is demonstrated how these technologies are applied to design favorable processes in order to generate true customer benefit.
Publish Date: 06-Oct-2021

Working as One to Advance Your HPAPI to Market

Creating the optimal pathway for your highly-potent small molecule drug candidate through each clinical phase is critical to your success. This webinar explains how to choose the right partner with the right expertise for your HPAPI development journey, from early phase to commercialization through innovation in manufacturing technology and flexible business models. Supported by a case study, we show how Lonza has developed an innovative production offering to accelerate development and provide a more flexible (HP)API supply for customers through the full product lifecycle.
Publish Date: 05-Oct-2021

Streamlined Selection of in vivo Predictive Dissolution Media (on-demand)

Oral administration is the most common delivery method for medicines. If a patient is to get full benefit from an oral medicine, the solid dosage form must first dissolve in their gastrointestinal (GI) fluids, and then permeate across the GI membrane. The efficient development of robust oral drug products requires biopredictive in vitro dissolution methods that can evaluate how the interplay between the drug formulation and the properties of the GI fluid impacts on performance. This webinar focuses on the design of dissolution media to support biopredictive dissolution testing, and highlights a method for selecting practical, physiologically relevant media based upon drug, formulation, and GI fluid properties.
Authors: Deanna Mudie
Publish Date: 29-Sep-2021

Streamlined Selection of in vivo Predictive Dissolution Media (presentation)

Oral administration is the most common delivery method for medicines. If a patient is to get full benefit from an oral medicine, the solid dosage form must first dissolve in their gastrointestinal (GI) fluids, and then permeate across the GI membrane. The efficient development of robust oral drug products requires biopredictive in vitro dissolution methods that can evaluate how the interplay between the drug formulation and the properties of the GI fluid impacts on performance. This webinar focuses on the design of dissolution media to support biopredictive dissolution testing, and highlights a method for selecting practical, physiologically relevant media based upon drug, formulation, and GI fluid properties.
Authors: Deanna Mudie
Publish Date: 29-Sep-2021

Bespoke and Flexible Cell Line Development Programs from Gene to Clinic

Creating cell lines with future manufacturability, cost of goods and speed in mind is of critical importance. How can time to the clinic be reduced and yet a drug candidate be equipped with a robust CMC-package from day one? Join Megan Mason, head of Cell Culture Development at Lonza Biologics to learn how you can chart an optimal path from gene to the clinic by tailoring your cell line development program to match your molecule type, timelines, yield requirements and risk priorities.
Publish Date: 23-Sep-2021

Local Treatment of Non-small Cell Lung Cancer with a Spray-Dried Bevacizumab Formulation

Local delivery of biotherapeutics to the lung holds great promise for treatment of lung diseases, but development of physically stable, biologically active dry powder formulations of large molecules for inhalation has remained a challenge. Here, spray drying was used to manufacture a dry powder pulmonary formulation of bevacizumab, a monoclonal antibody (mAb) approved to treat non-small cell lung cancer (NSCLC) by intravenous infusion. By reformulating bevacizumab for local delivery, reduced side effects, lower doses, and improved patient compliance are possible.
Publish Date: 01-Sep-2021

Spray-Dried Inhalation Formulations for Local Treatment of Lung Cancer

Lung cancer is the leading cause of cancer-related death among Americans. It is also the most common cancer worldwide, with nearly 2 million deaths per year. 90% of lung cancer cases are attributed to non-small-cell lung cancer (NSCLC). It has been reported that more than 50% of individuals with lung cancer die within one year of their diagnosis. The high mortality rate is attributed to a lack of early detection as well as a need for improved treatments. Read our technical article in AAPS News Magazine.
Publish Date: 27-Aug-2021

First-In-Human To Commercial: A Micro-dosing Journey

This on-demand webinar explores the benchmark practices for rapid progression from First-in-Human to large-scale commercial manufacture for micro-dosing API. Xcelodose®-based systems are an industry standard for rapid and accurate micro-dosing and an integral part of accelerated pathways to first-in-human studies. Utilization of the Xcelodose® technology can increase the speed to the clinic and quickly assess new compounds while remaining cost-conscious.  Upon successful clinical studies, scale up to large-scale manufacture has previously been a limitation. Micro-dosing with the innovative Harro Höfliger Modu-C Mid Speed Encapsulator, these limitations are no longer an impediment to scale-up and commercialization.
Publish Date: 26-Aug-2021

First-In-Human To Commercial: Micro-dosing Journey

These webinar slides explore the benchmark practices for rapid progression from First-in-Human to large-scale commercial manufacture for micro-dosing API. Xcelodose®-based systems are an industry standard for rapid and accurate micro-dosing and an integral part of accelerated pathways to first-in-human studies. Utilization of the Xcelodose® technology can increase the speed to the clinic and quickly assess new compounds while remaining cost-conscious.  Upon successful clinical studies, scale up to large-scale manufacture has previously been a limitation. Micro-dosing with the innovative Harro Höfliger Modu-C Mid Speed Encapsulator, these limitations are no longer an impediment to scale-up and commercialization.
Publish Date: 26-Aug-2021

in vitro -in silico Tools for Streamlined Development of Acalabrutinib Amorphous Solid Dispersion Tablets

Amorphous solid dispersion (ASD) dosage forms can improve the oral bioavailability of poorly water-soluble drugs, enabling the commercialization of new chemical entities and improving the efficacy and patient compliance of existing drugs. However, the development of robust, high-performing ASD dosage forms can be challenging, often requiring multiple formulation iterations, long timelines, and high cost. In a previous study, acalabrutinib/hydroxypropyl methylcellulose acetate succinate (HPMCAS)-H grade ASD tablets were shown to overcome the pH effect of commercially marketed Calquence in beagle dogs. This study describes the streamlined in vitro and in silico approach used to develop those ASD tablets.
Publish Date: 13-Aug-2021