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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: 16-Feb-2021

Enabling Streamlined Formulation Development of Amorphous Solid Dispersion Drug Products

To achieve robust amorphous solid dispersion (ASD) drug products, pharmaceutical scientists must design these formulations to attain several key attributes.  This includes in vivo performance, stability and manufacturability, all while minimizing dosage form size. Combining knowledge of key drug, polymer and gastrointestinal properties--together with an in vitro and in silico toolkit--is critical for achieving key attributes, while reducing development timelines and drug substance requirements.  This webinar highlights Lonza’ s best practices for streamlined development of ASD drug products using traditional and novel formulation architectures.
Publish Date: 28-Jan-2021

Process Development Toward a Pro-Drug of R-Baclofen

This paper describes the process development conducted toward the multi-kilogram synthesis of a novel transported pro-drug of R-baclofen. The new route reported here is more efficient and sustainable than those reported previously and had the potential to become the commercial route of manufacture. To learn more, view our paper.
Authors: Sudhir Joshi
Publish Date: 15-Dec-2020

in vivo-predictive in vitro Methods for Characterizing Amorphous Solid Dispersions

A significant fraction of pharma and biotech pipelines are comprised of poorly soluble and, hence, poorly bioavailable compounds. Amorphous solid dispersions (ASDs) are a proven technology that have been commercialized in over twenty products. Key to progressing ASDs is the use of rapid, bulk-sparing methods to characterize ASD performance and identify commercially relevant formulations early, and avoid re-formulation later in the project lifecycle. This talk focuses on identification of methods for predicting ASD performance and case studies for poorly soluble molecules. To learn more, watch our on-demand presentation.
Authors: David Lyon
Publish Date: 14-Dec-2020

5-Azacytidine Inhaled Dry Powder Formulation Profoundly Improves Pharmacokinetics and Efficacy for Lung Cancer Therapy

This on-demand presentation covers manufactured respirable 5AZA powder using a modified spray drying process. Pharmacokinetics of inhaled dry powder and aqueous formulations of 5AZA is compared to an injected formulation. Efficacy studies and effect of therapy on the epigenome were conducted in an orthotopic rat lung cancer model for inhaled formulations. These findings could lead to widespread use of this drug as the first inhaled dry powder therapeutic for treating local and metastatic lung cancer, for adjuvant therapy, and in combination with immunotherapy to improve patient survival.  To learn more, watch our presentation.
Authors: David Lyon
Publish Date: 10-Dec-2020

Secondary Drying: The Finishing Touch in Spray-Dried Dispersion Manufacturing

Approximately 70% of new drug candidates have issues with bioavailability or solubility, leading to potential clinical, development, and/or manufacturing challenges. Kimberly Shepard shares insights on a technology that can help overcome these issues--amorphous spray-dried dispersions (SDD). The technology is applicable to a wide variety of molecules and target profiles, and by stabilizing a drug in its amorphous state, improves stability and bioavailability.
Publish Date: 01-Dec-2020

Podcast: Innovations in HPAPI and Antibody-Drug Conjugates Drug Development

Antibody-drug conjugates (ADCs), which use antibodies to send cancer-killing molecules directly where they are needed, are one area of focus for oncology researchers. ADCs combine the potency of small molecules (highly potent APIs, or HPAPI) with the selectivity of cancer-specific antibodies.  To learn more, watch our podcast.
Authors: Maurits Janssen
Publish Date: 22-Nov-2020

Applying Visual Techniques to the Product Design of Lipid Multiparticulates

Lipid multiparticulates (LMPs) are versatile drug delivery systems that offer flexibility in both drug release and final dosage form. The wide variety of available matrices and formulation approaches make LMPs amenable to a broad range of targeted release kinetics and delivery strategies. The solvent-free melt-spray-congeal process results in LMPs with controlled and narrow particle size distributions. For the final dosage form, LMPs can be given as sachets, incorporated into capsules and tablets, or used as injectables.  This webinar discusses the process for formulation selection and LMP manufacturing through the lens of visual techniques to study critical-to-quality attributes.
Publish Date: 20-Nov-2020

APIs and Toxins/Linkers for ADCs: A Vision on Highly Potent Development, Scale-up and Manufacturing

Drug development based on potent compounds can be quite challenging. Complications with the interface between operations in drug substance and drug product handling can result in increased program complexity and cost. This also applies when the potent compound is used as toxin/linker for application in ADCs.  In this presentation, we will elaborate on best practices and requirements that facilitate accelerated timelines to clinic & market: (1) Development, rapid scaling and commercial production of HPAPI drug substance, (2) Integrated containment for particle engineering and drug products, and (3) Impact of supporting integrated service-offerings on expansion strategies.
Authors: Maurits Janssen
Publish Date: 20-Nov-2020

Immunotherapy: Antibody Drug Conjugates From a Small Molecule Perspective

Oncology is a major driver of demand for small molecule therapies. Antibody drug conjugates (ADCs) offer the ability to more effectively target cells with active pharmaceutical ingredients. Maurits Janssen and Bernhard Stump discuss important considerations in ADC development, including antibody engineering, toxin selection, and linker design.
Publish Date: 17-Nov-2020