More than 75 % of new chemical entities are poorly soluble and require bioavailability-enhancing excipients. The application of excipients in advanced pharmaceutical processes, such as hot melt extrusion and 3D-printing, aligned with advanced approaches towards personalized medicine, requires special features. Lipid-based excipients (LBEs) are “natural contenders” for these tasks. However, until now, it has not been possible to fully exploit the potential of LBEs.

The main challenge is the unstable solid state of current LBEs, e.g. polymorphism, leading to instability of the final dosage form. Compared to polymers, the low melting temperature of lipids, combined with highly crystalline arrangement, limits their application in advanced pharmaceutical processes such as hot melt extrusion and 3D-printing.

In recent years, the standardization of biologics manufacturing processes has given product developers multiple viable options for producing biologics. These options include building an in-house production system or partnering with a contract biologics manufacturer. Although building in-house does offer the advantage of direct control; the time, labor, and spend required to implement this often makes it the inefficient choice. On the other hand, working with an experienced contract manufacturer can help you save time and costs by leveraging a deep pool of industry experience. However, the process of selecting the right CDMO partner needs to be performed after careful analysis of many factors: any of which, if overlooked, can create risk of delay or cost overrun. In this session, we will discuss the key parameters that you can easily assess when choosing the right innovative CDMO partner that will keep you competitive in a rapidly evolving market.

Container closure integrity (CCI) testing is determined by evaluating whether a given container maintains its sterile barrier. It is a mandatory step in the design verification phase of a drug – device combination product development. Several methods exist with different advantages and limitations.

During this session, we will address the following points:

- Probabilistic vs deterministic CCI Testing

- Presentation of the different deterministic CCI testing methods with applications and limitations

- What to consider when selecting CCI testing method.

At the end of the session, attendees should better understand the influence of the drug specificities to select the most suitable technical option for Container Closure Integrity testing activities based on the advantages and limitations of different techniques available on the market.