Data Analysis

When it comes to measuring drugs in biological samples, what is needed, what is quantifiable – and what role should analytical scientists really be playing?

Can R&D organizations really afford to kill off analytical data that could be used for future decision-making? Perhaps it’s time to breathe life back into analytical data environments.

To formulate successfully with HA it is essential to understand the impact of factors such as molecular weight, molecular structure, concentration and degree of cross-linking on rheological characteristics such as viscoelasticity which are directly linked to aspects of product performance. Linking structural characteristics to product performance, via rheological properties, supports smart, fast, and effective formulation. The following study shows how rheology and particle size measurements can be used to characterize the physical properties of HA dermal fillers.

Polyol-induced increases in thermal stability of antibodies. See how Differential scanning calorimetry can be used to assess the effects of polyol excipients on antibodies. DSC was used to monitor polyol-induced increases in thermal stability across seven monoclonal antibodies. The increases in thermal stability were measured as a function of polyol concentration and orientation of hydroxyl groups. It was found that increases in thermal stability were linear with respect to alcohol concentration.

In this report, we illustrate the utility of calorimetry in making better laboratory decisions. Examples will include improved protein construct selection for scale-up; direct measurement of the effects of mutations and post-translational modifications on protein stability; rapid optimization of solvent formulation; direct measurement of substrate and inhibitor binding affinity; determination of the mode of inhibitor binding; characterization of protein-protein interactions; and improved structural biology efficiency, when used in conjunction of other biophysical methods.

See how you can use DSC to save you money in your contract development lab. This paper provides an overview of the workflow typically associated with preformulation projects at a contract development organization as well as provides a general framework for conducting preformulation studies that leverages the application of biophysical techniques such as DSC and traditional analytics by employing statistical design. A case study involving the formulation development of a monoclonal antibody is presented to detail the utility and potential limitations of DSC in support of preformulation for a variety of protein products.

Is the heat applied in gas chromatography-mass spectrometry really responsible for false results? And, if so, how often?

The role that nanoparticles play in the rapidly developing field of ‘NanoMedicine’ has been discussed previously in Chapter 5. In this Chapter, we review the specific mechanisms by which such nanoparticles are designed and formulated and in which NTA has had a significant part to play.

The ability to quickly and reproducibly measure coffee ground particle size and size distributions is important during grinding operations to ensure that the coffee quality is maintained and that the correct grade is produced. The Mastersizer 3000 and the Funnel Sample Feeder for the Aero S dry powder disperser provides this capability, offering a rapid alternative to traditional sieve analysis.

The combination of static microscopy and Raman spectroscopy in the Morphologi G3-ID enables automated chemical identification of protein aggregates and other contaminants in a biotherapeutic sample, either in suspension via a thin-path wet cell or on a filter membrane.