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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

When using a closed and automated manufacturing platform, is there an option to maintain flexibility?

To allow greater flexibility and better targeting of CAR T cell therapies, Astellas developed convertibleCAR™ T cells, which kill antigen-expressing target cells only in the presence of an activating bispecific adapter. Here, we will discuss the clinical manufacturing of autologous convertibleCAR T cells, with a special focus on automation of the process using the Lonza Cocoon® Platform.
Publish Date: 11-Aug-2021

Dry Powder Inhalation Delivery of Monoclonal Antibodies On-demand

Monoclonal antibodies (mAbs) are powerful therapeutics that address unmet treatment needs in a wide range of serious diseases. Local delivery of mAbs used in the treatment of lung indications via the inhalation route may help reduce dose, limit systemic exposure of healthy tissues, and lessen adverse events while improving patient compliance and lowering the cost of treatment. This webinar describes the use of spray drying to manufacture dry-powder inhaled formulations of a monoclonal antibody for lung cancer. The resulting formulation was shown to be shelf-stable at ambient temperature, have aerosol properties targeted for delivery to the deep lung, and was efficacious at reducing tumor burden in a rat model of non-small-cell lung cancer.
Publish Date: 22-Jul-2021

Dry Powder Inhalation Delivery of Monoclonal Antibodies: Slides

Monoclonal antibodies (mAbs) are powerful therapeutics that address unmet treatment needs in a wide range of serious diseases. Local delivery of mAbs used in the treatment of lung indications via the inhalation route may help reduce dose, limit systemic exposure of healthy tissues, and lessen adverse events while improving patient compliance and lowering the cost of treatment. This webinar describes the use of spray drying to manufacture dry-powder inhaled formulations of a monoclonal antibody for lung cancer. The resulting formulation was shown to be shelf-stable at ambient temperature, have aerosol properties targeted for delivery to the deep lung, and was efficacious at reducing tumor burden in a rat model of non-small-cell lung cancer.
Publish Date: 22-Jul-2021

The Good, The Bad, And The Ugly: How Does Identifying And Mitigating Potential For Immunogenicity And Immunotoxicity De-Risk And Accelerate Your Drug Development?

In this webinar, we explore the challenges of assessing the immunosafety profile when moving a drug candidate to first-in-human studies. Our expert shares key considerations and pitfalls to avoid along the way. Case studies highlight how in vitro  immunotoxicity assessments add significant value by predicting risk early. This knowledge allows for modifications to the candidate or package design to mitigate risk and increase the likelihood of a successful study.
Authors: Noel Smith
Publish Date: 14-Jul-2021

Delivering an end-to-end industrialization roadmap for autologous cell therapy

An end-to-end industrialization roadmap for autologous cell therapies: specificities and challenges, leveraging automation for scalability with the Cocoon® Platform, and building a vein-to-vein network to achieve ‘just-in-time’ delivery of therapies.
Publish Date: 06-Jul-2021