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Getting a Handle on High Potency

As a result of innovations in high-demand sectors like oncology, new highly potent APIs (HPAPI) are continuously entering the market. Although HPAPI are designed to be more effective at the site of therapy, manufacturing and handling them pose risks to the operators due to their toxicity, and the required low concentrations make it difficult to accurately dose in oral solid applications. Liquid-fill hard capsules (LFHCs) can help protect engineers while handling HPAPI and formulate accurate low-dose, solid oral applications. LFHCs’ three-step process – mix, fill, and seal – allows for a simple and straightforward manufacturing process. With safety and micro-dosing advantages – as well as bioavailability enhancement potential – LFHCs can be used to develop oral formulations based on HPAPIs more safely and effectively, paving a smoother path from clinical trials to commercialization. To learn more, read our article.
Authors: Alyn McNaughton
Publish Date: 01-Aug-2020

Technology Selection for Improving Bioavailability of Poorly Soluble Compounds

Drug development pipelines are inundated with candidates with poor oral bioavailability. In order achieve target exposure and be efficacious, these compounds often require solubility and/or dissolution rate enhancement with an enabling technology. Many technologies exist at the disposal of drug development scientists, and the selection of which is crucial to ensure success at reasonable cost and timeline. The ultimate goal in any drug development program is to propose the simplest, most cost-effective solution for developing the targeted drug product and hinges on applying an integrated approach where bio-performance, stability and manufacture are considered throughout the development cycle. This on-demand webinar will focus on some of the key considerations for selecting and evaluating the appropriate technology for improving the oral bioavailability of poorly soluble compounds, centered around using a hypothesis driven approach to formulation.
Authors: Aaron Stewart
Publish Date: 30-Jul-2020

Engineering Approaches to Respiratory Drug Delivery

Spray drying and jet milling are commercially viable engineering processes for the development of respirable drug products.  This case study explores the material and performance properties of mannitol, spray-dried and jet-milled, for respiratory delivery.  The head to head comparison reveals opportunities and risks for designing a product based on each approach.  Key learning objectives include: (1) understanding the pros and cons of spray drying vs. jet milling; (2) learning how to conduct a risk assessment to inform engineering technology selection; and (3) exploring how particle morphology influences aerodynamic performance.  To learn more, please view our on-demand webinar.
Authors: Cameron Kadleck, Jimmy Beaty
Publish Date: 30-Jul-2020

Executive Summary: Technology Selection for Bioavailability Enhancement Programs

Due to the growing incidence of low drug solubility in the pharmaceutical discovery and development pipeline the number of enabling technologies that are employed to improve oral drug absorption and bioavailability (BA) are also growing. Most commonly utilized are particle size reduction, amorphous solid dispersions and lipid-based technologies. Facilitated by advances in predictive methodologies, amorphous solid dispersions have become the most prevalent commercially deployed BA technology. This executive summary provides an overview of this topic.
Authors: Dr. David Lyon
Publish Date: 23-Jul-2020

Lonza Small Molecule Capabilities: Drug Substance to Drug Product, Parenteral to Oral

Lonza Pharma and Biotech is a multi-national contract development & manufacturing organization (CDMO) that specializes in difficult-to-manufacture drug substance, drug product intermediates and drug product. In this introductory 30-minute interactive discussion, David Lyon, Sr. Fellow, Research, will highlight Lonza’s capabilities across the spectrum of drug development inclusive of parenteral, inhaled, and oral drug delivery. This introductory discussion will lead the way to future discussions taking deep dives into the highlighted areas.
Authors: Dr. David Lyon
Publish Date: 23-Jul-2020

Executive Summary: in vitro Test Methodologies for Bioavailability Enhancement

This executive summary discusses in vitro methodologies used at Lonza for the characterization of bioavailability enhancing formulations, as well as criteria for selecting the right in vitro method based on compound properties and dose. To learn more, please download our executive summary.
Authors: Aaron Stewart
Publish Date: 23-Jul-2020

Solvent-Assisted Secondary Drying of Spray-Dried Polymers

The purpose of this work is to introduce solvent-assisted secondary drying, a method used to accelerate the residual solvent removal from spray-dried materials. Spray drying is used to manufacture amorphous solid dispersions, which enhance the bioavailability of active pharmaceutical ingredients (APIs) with low aqueous solubility. In the spray drying process, API and excipients are co-dissolved in a volatile organic solvent, atomized into droplets through a nozzle, and introduced to a drying chamber containing heated nitrogen gas. The product dries rapidly to form a powder, but small amounts of residual solvent remain in the product and must be removed in a secondary drying process. For some spray-dried materials, secondary drying by traditional techniques can take days and requires balancing stability risks with process time.  To learn more, please download our publication.
Authors: Kimberly Shepard, April Dower, Alyssa Ekdahl, Michael Morgen, John Baumann, David Vodak
Publish Date: 22-Jul-2020

De-risking and accelerating oral peptide delivery via computational drug development tools

As more low-soluble molecules enter the development pipeline, selecting the right enabling technology for bioavailability enhancement is critical in order to be time- and cost-efficient. Choosing the right technology no longer has to be a trial-and-error process with innovations in computational tools such as molecular dynamics simulation (MDS). These tools can help accelerate drug development timelines and ensure that critical drug products reach the patients who need them quickly and safely. Read more in our article in Manufacturing Chemist.
Authors: Leigh Ford, Vincent Jannin and Hassan Benameur
Publish Date: 22-Jul-2020

Mini-Monoplant Technology for Pharmaceutical Manufacturing

Pharmaceutical production has historically relied on multipurpose batch vessels in order to produce material through scheduled production campaigns. Although this method is flexible, it is becoming less effective in addressing the changing landscape of pharmaceutical production, where more complex and potent molecules are required to be produced more rapidly and can have fluctuations in their demand. This article describes a method for developing intensified and dedicated pharmaceutical processes, known as mini-monoplants. Key value-generating aspects are described at each stage of development, from lab-based development of best-in-class processes to factory-based development for an accelerated time to market and finally to mini-monoplant technology for production at commercial scale. To learn more, read our publication.
Authors: Brendon Doyle, Petteri Elsner, Bernhard Gutmann, Olivier Hannaerts, Christof Aellig, Arturo Macchi, Dominique Roberge
Publish Date: 22-Jul-2020

Accelerated development of first-in-human programs - SimpliFiH® Solutions

This webinar includes case studies to further discuss the services available through Lonza’s SimpliFiH® Solutions program and will provide a line of sight for post First-In-Human milestones. This integrated program enables drug substance and drug product delivery in about 40 weeks from the start of the project to the readiness for clinical.  To learn more, please view our webinar slides
Authors: Dr. David Lyon, Conrad Roten
Publish Date: 24-Jun-2020