All
Scalable Solutions for Novel Oral Solid Dose Development and Manufacturing
August 1st 2024Developing successful oral solid dosage forms necessitates partnering with a CDMO equipped with distinctive technologies and expertise to enable support across solid-state characterization, formulation development and scale-up manufacturing processes.
Exploring best-practice manufacturing strategies for highly potent oral solid dosage forms
July 29th 2024As the number of highly potent oral solid dose (HPOSD) drugs in development and on the market increases, so are regulator’s expectations regarding their safe manufacture. In this white paper Pfizer CentreOne examines what developers and their manufacturing partners need to know about its unique regulatory challenges and how to navigate HPOSD’s complex manufacturing environment successfully.
Successful Drug Development Strategies Using Lipid-Based Formulations and Softgels
July 24th 2024Lipid-based formulations (LBFs) and softgels can offer numerous advantages in terms of clinical and commercial potential. Integrating formulation and manufacturing to enhance drug solubility and market speed can help unlock these benefits. Learn more about:
Science of Scale for Spray-Dried Intermediates (July 2024)
July 24th 2024Speed to market is a critical aspect of developing new pharmaceutical products, and scale-up-or scale-down-can play a key part in that process. Significant interest has been focused on the science of scale for spray drying, since this process is the leading technology for formulating drugs with slow dissolution rates or poor solubility, which results in low bioavailability. Lonza has over 20 years of experience in the scale-up and scale-down of spray drying processes. To learn more, read our executive summary.
Pharmaceutical Companies Can Optimize Enterprise Asset Management and Achieve Success
July 22nd 2024An integrated platform that keeps real-time data in a single location can be a major asset for pharmaceutical companies, as it saves time and money, leading to better quality products and higher profits.
Roles and Responsibilities of Specialized Clinical Supply Experts
June 21st 2024When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains. Having a team of individuals with specialized expertise in different areas of clinical supply—including protocol review and early operational planning, to managing the development and execution of a sound clinical supply strategy—can prove invaluable to the overall suitability and performance of the supply chain, and in turn, the successful execution of the study itself.