Scott Patterson, VP of Commercial Sales, along with Business Review presented a webinar entitled: CMO/CDMO Facilities Gain Value with Single-Use Containment. In this webinar Scott discusses flexible containment, containment performance using a case study for an OSD process, shared facilities and HBEL/ADE requirements, and benefits global CDMO’s realize with flexible containment.
Time to experiment, time to clinic, and time to market is becoming even more important for developers and manufacturers of biopharmaceuticals. At the same time, the amount of data enclosed in biologic license applications are more comprehensive to avoid extended review. In this webinar we will review three fields that enable reduced timelines and improved outcomes of process development activities.
This webinar discusses how the unique properties of gelatin have been used to develop chewable softgel formulations for the pediatric and geriatric patient populations.
Thermo Fisher Scientific's Kaspar van den Dries and Helena Teles discuss potential mechanisms of increased absorption with lipid formulations and appropriate screening tools that are used during the development approach of these formulations, as well as scale up and industrialization considerations.
During this interactive webinar, the speakers involved will utilize their experience to guide you through the EU product launch process, from submitting your Marketing Application (MA) to final distribution of drug product to the end-user.
Introduced to the pharmaceutical industry decades ago, lipid-based drug delivery systems are the most well-studied and widely utilized technology among all available bioavailability enhancement technologies. Lipid-based drug delivery systems have delivered more than 60 unique drug molecules to market – and counting. Watch this webinar to learn more about the importance of and recent developments in lipid-based drug delivery systems, novel lipid excipients, models, and screening tools for early phase development of lipid-based drug delivery systems, and using mechanistic studies and modeling to predict the impact of lipids on oral absorption.
Many biopharmaceutical drug formulations have some degree of oxygen sensitivity. Topics for this webinar include how oxygen levels in finished parenteral drug containers can be determined for oxygen scavenger & stability studies, for determining inherent primary packaging integrity, and for optimizing & qualifying inert gas purging system during filling.
When CDMOs understand what motivates drug innovators to outsource, who is involved in the service provider selection decision, and which CDMO attributes have the greatest influence on CDMO selection they are able to communicate what is unique about their offering to the right audience at the right time.
This webinar describes the use of positive controls as an important element of CCI studies designed to validate packaging components for CCI or to qualify processes for producing good CCI.
This webinar presents how to design and conduct studies to assess the total oxygen permeation rate of your pre-filled syringes, and how to determine if the permeation is primarily through the plunger or through the tip. Protecting oxygen-sensitive formulations during filling will also be discussed.
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