Newsletter | June 10, 2021

06.10.21 -- Adapting for challenges in oral solid dose development and manufacturing

Strategies for API solubility and bioavailability enhancement

A rational computational and formulation strategy, based on a drug molecule’s physicochemical properties, bypasses conventional trial-and-error methods for solubility challenges and excipient selection. With this approach, you can eliminate unnecessary testing, improve the efficacy of your formulation, and increase your overall speed to market.

Setting a strong foundation for your oral solid dose product to support late-stage development

Drug sponsors face significant pressure to reduce the time required to move a new molecule through Phase I and into Phase II trials. At early stage, sponsors need to keep the formulation as simple as possible, which means identifying the desired quality attributes and selecting only the requirements that align closest to the objectives of each clinical trial stage.

Technology transfers: best practices for optimizing success and mitigating risk

Transferring production between sites can provide a variety of strategic advantages. Learn more about overcoming hurdles and ensuring project success, including project management tools, people, network capabilities, process improvement, and culture, and addressing challenges and risks.

Navigating the adoption of continuous pharma manufacturing

Continuous manufacturing can predictably shorten processing times, reduce the risk of human error, deliver better consistency and yield, and provide higher quality assurance. Driving a path forward requires a closer look at the current global challenges and barriers and the ideas and initiatives necessary to fulfill its potential.

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