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Particle Engineering Through Micronization

Particle engineering is a key step in the development process that occurs at the drug substance-drug product interface.  Micronization is one of the methods used in particle engineering to control the particle size distribution, enhance bioavailability, and improve content uniformity.  Phase appropriate micronization processes and analytical methods can be developed to supply material for pre-clinical studies, clinical trials, and commercialization.  To learn more, view the on-demand presentation.
Authors: Jason Riggs
Publish Date: 09-Jun-2021

Technology Selection for Improving the Oral Bioavailability of Poorly Soluble Compounds

A large and increasing fraction of orally administered small molecules in pharma company pipelines have poor oral absorption due to low aqueous solubility or dissolution rate, requiring an enabling technology to achieve desired exposure. Selecting the appropriate technology for your compound requires careful consideration of the compound physicochemical properties, target dose and pharmacokinetic profile, as well as overall market image. This on-demand presentation covers a general overview of some of the most common bioavailability enhancing technologies and selection criteria for poorly soluble compounds.
Authors: Aaron Stewart
Publish Date: 09-Jun-2021

Lonza Integrated Offering

To rapidly progress a molecule, it is important to synthesize the drug substance and determine its’ most stable form such that it is compatible with the final drug product formulation. This on-demand presentation focuses on Lonza’s integrated offering—SimpliFiH® Solutions—an integrated FiH drug substance to drug product services platform. 
Authors: David Lyon
Publish Date: 09-Jun-2021

Solid Form Screening and its Role in Drug Development

Solid form screening is a critical component of drug development. Identification of a progressible solid form early in development can save significant time and money and Lonza’s Solid Form Services Group is an agile group that can meet these needs.  To learn more, view the on-demand presentation.
Authors: Michael Grass
Publish Date: 09-Jun-2021

Powder in Capsule: A Way to Accelerate Drug Product Development by Technologies

The Powder in Capsule (PIC) approach by means of micro-dosing provides an alternative pathway for drug development. Micro-dosing provides a quick way to evaluate the drug substance performance and remain cost-conscious to investments in the development of traditional formulated dosage forms. View the on-demand presentation to learn more on how this can help accelerate your proof of concept to the clinic.
Authors: Mark Cappucci
Publish Date: 09-Jun-2021

Introducing our library of pre-developed assays for cell and gene therapies

In a presentation taking place in the opening plenary session of the Gene Therapy Analytical Development EU summit 2021, Dr Behnam Ahmadian, Global Head of Process Development for the Cell & Gene Technologies Business Unit at Lonza, introduces a library of pre-developed, fast-qualify assays to expedite and harmonize the development of cell & gene therapies
Authors: Behnam Ahmadian
Publish Date: 07-Jun-2021

Scale-Up and Commercialization of Spray-Dried Amorphous Solid Dispersions

Spray drying is a preferred process for manufacturing amorphous solid dispersions to provide oral bioavailability enhancement for low solubility small molecules, which represent approximately 70% of the new chemical entity pipeline. A robust, efficient scale-up process that ensures critical-to-quality attributes (CQAs) are maintained is crucial to the commercial viability of these molecules.  This webinar focuses on manufacturing aspects of amorphous spray-dried dispersions (SDDs) to enable successful scale-up and optimization of the process. An overview of spray drying and typical scale-up challenges is presented along with methodologies that enable rapid scale-up that is right the first time from clinical to commercial scale.
Publish Date: 27-May-2021

Pulmonary Delivery of Spray-Dried Monoclonal Antibody Formulations

In the case study presented here, spray drying was used to manufacture a dry-powder pulmonary formulation of bevacizumab, a monoclonal antibody 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. To learn more, please read our case study.
Publish Date: 13-May-2021

Podcast: Bioavailability and Dissolution Testing

In this podcast, Deanna Mudie discusses the importance of bioavailability enhancement and describes some of the methods used, including the value of dissolution testing when developing oral drug products.  She also shares her top tips for how to select the correct dissolution media.
Authors: Deanna Mudie
Publish Date: 10-May-2021

Biorelevant Aerosol Testing and Modeling for Respiratory Drug Delivery

RDD 2021 Workshop Presentation: This on-demand presentation provides an overview of the differences in approach for jet milling and spray drying particle engineering. You will learn what types of questions can be answered using biorelevant aerosol testing. Additionally, you will understand how selection of parameters for sensitivity analysis in respiratory drug delivery modeling can provide insights into the in vivo fate of inhaled therapies.
Publish Date: 07-May-2021