cDPI: Line extension with capsule-based inhalation drug delivery

Companies often experience regulatory challenges during an inspection of aging facilities, requiring them to initiate projects to optimize product protection and updating to current standards for classified areas for biopharma manufacturing. For a long time, the company response has been to improve the existing classified areas or maybe even upgrading to a higher grade of classification. However, it may be more appropriate, and improve product protection, to instead implement the use of closed system processes and downgrade room classification during these facility renovation projects. If closed systems are fully utilized, then a CNC space can be used. As well as reducing the complexity of operations, this will reduce capital and operating costs.

The impact of Brexit on the life sciences industry: separating fact from fiction to prepare for the impact of a change in the relationship between the UK and EU.

Differential Scanning Calorimetry (DSC) is the most widely used thermal analysis technique. A well-established application is the purity determination of organic substances. The method is based on the van’t Hoff law of melting point depression of eutectic systems. Purities between 90 and 100 mol% can be reliably determined. Purity determination is used in the chemical and pharmaceutical industries and also for additives in the food and plastics industries.

Recently investigators have begun to harness new technology such as microfluidic modulation spectroscopy (MMS) to reveal protein structural changes, as a solid understanding of structure and function is extremely important to the effectiveness of biotherapeutic drugs and scientist today are challenged in gathering a complete understanding with current tools. During the biomanufacturing process, proteins such as antibodies, often undergo conformational changes that can alter their secondary structure, leading to critical variations in their overall function. These changes have been historically difficult to detect, as traditional analytical techniques are not great at detecting small differences in protein structure.