White Paper: SimpliFiH®️ Solutions for Accelerated Pharmaceutical Development
With the pharmaceutical industry’s focus on accelerating all aspects of drug discovery and development, it is crucial to reduce the time from initial product concept to first-in-human clinical completion. Numerous factors can slow this process, but challenges can be overcome by aligning with a single, integrated Contract Development and Manufacturing Organization (CDMO) to reduce the time, complexity, risks, and costs associated with engaging multiple partners.
Lonza Capsules & Health Ingredients
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2015On CPHI since
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Other Content from Lonza Capsules & Health Ingredients (7)
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News CPHI North America 2023 – From the Floor
Follow along for live updates from the Content team as we bring you the latest from CPHI North America 2023 - from session talks, panel discussions, interviews, and more, there's a lot to discover with CPHI Online at the Pennsylvania Convention Center! -
Video Lonza
Enabling a healthier world. -
News Lonza signs five-year collaboration deal with VC firm Bioqube to speed up portfolio companies’ development and manufacturing
The offering will accelerate timelines for the development and manufacturing of molecules and disruptive technologies -
Video Making a Splash in the US Market: How PBPK Modeling is Playing a Central Role in Risk Reduction in Early Drug Development
Rapid and efficient development of drug candidates is increasingly important for pharmaceutical companies with accelerated timelines and funding constraints. However, many early drug candidates have poor oral absorption properties making it challenging to achieve target pharmacokinetic (PK) profiles. Without upfront knowledge of absorption risks and mitigation strategies, poor absorption can significantly impact preclinical and clinical study timelines and costs. Physiologically-based pharmacokinetic (PBPK) modeling software, such as the GastroPlus® platform from Simulations Plus, simulates dynamic physiological factors impacting oral performance. When coupled with in vitro measurements, PBPK modeling is effective in early development for 1) identifying absorption risks, 2) assessing the potential for solubility enhancing formulations such as salts, cocrystals, or amorphous solid dispersions to mitigate these risks, and 3) designing and optimizing preclinical and clinical studies with respect to dose, prandial state, or gastric pH modification to maximize the likelihood of achieving desired PK profiles. In this presentation, we will demonstrate how PBPK models combined with Lonza’s custom and off-the shelf in vitro tools and solubility enhancement expertise can be used to identify and mitigate absorption risks in early drug development, reducing the need for drug product reformulation or repeated preclinical or clinical studies. Key Learning Objectives: Learn how PBPK modeling can identify potential oral absorption risks and mitigation strategies (e.g. bioavailability enhancement) for early drug candidates. Learn how PBPK modeling coupled with in vitro testing can guide early selection of drug form and formulation to achieve clinical study goals. Gain insights into how key drug and formulation factors including solubility, permeability, and dissolution rate can impact absorption risks such as poor oral bioavailability, food-drug interactions, and pH-dependent DDI effects. -
News Lonza Switzerland site to undergo expansion of microbial development capabilities
The expansion includes the installation of a pilot suite with a 50-L fermenter and automation upgrades to accelerate clinical and commercial projects -
News Lonza boosts exosome capability with Codiak BioSciences facility acquisition
The companies will establish a Centre of Excellence focused on exosome manufacturing and characterization technologies -
News Lonza to establish multi-product fill and finish line in China
The new production line at Guangzhou site will supply global and domestic companies with clinical and commercial batches
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