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Solid-Form Screening and Rational Cocrystal Design - Presentation

Solid-form screening and characterization is a crucial part of drug substance development and pre-formulation. Knowledge of the underlying fundamentals of polymorphism, hydrates/solvates, salts, and cocrystals is essential to establish an understanding of a drug substance and its solid-form throughout the drug development lifecycle. In this webcast, experts will discuss many aspects of solid-form screening including in-silico screening, which can save time and speed up the solid-form development process. A case study will review in-silico screening of cocrystals of a pharmacophore using hydrogen bond energies and hydrogen bond propensities. A second case study will examine cocrystallization of nutraceuticals and their versatile use as coformers.  To learn more, download our webinar slides.
Publish Date: 04-Mar-2021

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

Avoiding CMC Failures Through Phase-appropriate Clinical Development and Supply Chain Setup

Today’s clinical pipelines are at record levels and driven by innovation in approach, including use of AI in discovery and ongoing investment in new and more patient-centric therapies. More and more of these programs follow accelerated development and approval pathways. As a result, target timelines for the start of clinical trials are getting shorter. In this already complex environment, Chemical and Manufacturing Controls should not be the cause for increased risk or delays.  This on-demand presentation covers phase-appropriate development approaches and supply chain solutions for integrated drug substance and drug product projects that can accelerate program timelines and reduce overall complexity and risk.
Publish Date: 05-Feb-2021

Enabling Streamlined Formulation Development of Amorphous Solid Dispersions

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.  To learn more, download our webinar slides.
Publish Date: 28-Jan-2021

Enabling Streamlined Formulation Development of Amorphous Solid Dispersion Drug Products - On-demand

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

High Drug Loading Amorphous Solid Dispersions

For certain poorly soluble drugs, amorphous solid dispersions (ASDs) can be formulated to increase bioavailability. However, these dosage forms often require multiple large tablets and capsules, which can cause difficulties for some patients.  Deanna Mudie and Aaron Stewart explain how a high-loaded dosage form (HLDF) architecture for may be designed to reduce ASD tablet mass by as much as 40% without sacrificing effectiveness or stability.  To learn more, read our article in Contract Pharma.
Publish Date: 27-Jan-2021

Digitalisation in HPAPI development & manufacturing – hype or valuable toolbox?

How is digitization helping advance development of highly potent API drug substance and products? Lonza experts Conrad Roten and Niklaus Künzle explain how a growing toolbox of digital technologies can be applied in many areas of process development and production to accelerate improvements in HPAPI production.  To learn more, read our article in European Pharmaceutical Manufacturer.
Publish Date: 19-Jan-2021

Multi-Particulate Manufacturing – How Does Experiment Design Affect Multi-Particulates Manufacturing?

Multi-particulate dosage forms can help improve bioavailability for certain substances and can also improve patient outcomes. Lonza experts Namrata Vora, Karthikeyan Selvaraj, Danica Cartwright and Ryan Larmon describe findings on multiparticulate drug development with applicable learnings on experiment design for the pharma & biotech industry. To learn more, read our article in Drug Development.
Authors: Namrata Vora
Publish Date: 10-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