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Laboratory Instrumentation White Papers

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1-15 of 125 results
Studying Low-Affinity Fragments of Ligands by ITC
| By Malvern Instruments
Molecular recognition is a fundamental prerequisite to all biological processes from enzymatic catalysis to signal transduction. The modern pharmaceutical industry is built upon the concept of selective intervention in such systems (1). Furthermore, similar concepts are being implemented, through supramolecular chemistry, to develop novel smart materials, components for nanotechnology and molecular electronics (2). If we are to harness the full potential of molecular recognition, it is essential that we understand the subtle interplay between structure and thermodynamics in complex formation.
Automation > Laboratory Instrumentation > White Papers
Pharmaceutical Excipient Characterisation
| By Malvern Instruments
The aim of formulation development is to design a product and its manufacturing process to consistently deliver the intended Quality Target Product Profile (QTPP). This involves determining the Critical Quality Attributes (CQAs) for the Active Pharmaceutical Ingredient (API) and excipients that define the performance of the product. These are generally identified through an assessment of the extent to which the variation in a specific attribute, for example particle size, can impact the drug product’s quality and performance.
Automation > Laboratory Instrumentation > White Papers
Differentiation and Characterisation of Subvisible Particulates in Therapeutic Protein Products
| By Malvern Instruments
The formation of protein aggregates is a particular concern for parenteral administration biopharmaceuticals due to the potential for increased immunogenicity. As a consequence, there is an expectation from regulatory agencies for companies to monitor and, if required, reduce the levels of sub-visible particles present in therapeutic protein from manufacture through their complete shelf life.
Automation > Laboratory Instrumentation > White Papers
Revealing Kinase Inhibitor Mechanisms: ITC Leads the Way
| By Malvern Instruments
The kinome of an organism is the set of protein kinases in its genome and these protein-modifying enzymes are potential targets in a number of therapeutic areas. Studies to characterise the human kinome, together with the explosion of available kinase crystal structures over recent years, have led to an increased focus on kinases as potential targets for pharmaceutical intervention.
Automation > Laboratory Instrumentation > White Papers
Ten Ways to…Optimise Rheology to Increase Dispersion/Colloidal/Emulsion Stability
| By Malvern Instruments
The following ten points highlight general methods of designing and interpreting rheological tests to optimise sample stability.
Automation > Laboratory Instrumentation > White Papers
Identification of Agglomerates Using Automated Image Analysis
| By Malvern Instruments
The identification of agglomerates is seen as a challenge across many different industries. Automated image analysis systems provide a means for the classification of agglomerates, by differentiating particles based on their morphological parameters. The inclusion of spectroscopic measurements alongside imaging (MDRS) aids in understanding the type of agglomeration occurring with the sample.
Automation > Laboratory Instrumentation > White Papers
Ensuring Accurate and Repeatable Measurement of Proteins Using the Zetasizer APS
| By Malvern Instruments
In this application note, well known protein samples were used in a crosscontamination test to investigate the accuracy and repeatability of the Zetasizer APS dynamic light scattering (DLS) system.
Automation > Laboratory Instrumentation > White Papers
Effect of Excipients on Protein Formulation Viscosity
| By Malvern Instruments
In the development of injectable biotherapeutics, drug efficacy and patient experience are both very important parameters. In order to maximize activity and efficacy, biotherapeutics are usually delivered intravenously or subcutaneously in high concentrations, typically >100g/mL, due to their short half-life in plasma.
Automation > Laboratory Instrumentation > White Papers
Reverse Engineering of a Pharmaceutical Formulation Using the Morphologi G3-ID
| By Malvern Instruments
According to the definition established by the FDA, a generic drug is "a drug product which is comparable to a reference listed drug (RLD) product in dosage form, strength, route of administration, quality, performance characteristics, and intended use". Rigorous rules and regulations pertaining to abbreviated new drug application (ANDA) submissions are complex and the generic drug industry strives to meet these regulations to obtain FDA's approval.
Automation > Laboratory Instrumentation > White Papers
Molecular Weight Measurements of an Antibody Using Viscotek SEC-MALS 20
| By Malvern Instruments
Therapeutic recombinant antibodies, primarily of the Immunoglobulin G isotype (IgG), represent a growing proportion of biopharmaceuticals. There are an ever increasing number of approved antibody therapies available to treat a variety of modern-day diseases such as cancer, rheumatoid arthritis and diabetes. With many more candidate IgG's in the biopharmaceutical development pipeline the pressure to accurately understand and develop these candidates becomes more and more important.
Automation > Laboratory Instrumentation > White Papers
The use of ITC for Obtaining Enzyme Kinetic Constants
| By Malvern Instruments
Enzymes are proteins that function as biological catalysts and they play a crucial role in nearly all processes that take place in living organisms. Therefore studies of these molecules and the reactions they catalyze have been a core activity for biochemists for at least the past fifty years.
Automation > Laboratory Instrumentation > White Papers
Understanding the Conformational Stability of Protein Therapeutics using Raman Spectroscopy
| By Malvern Instruments
The combination of Dynamic Light Scattering (DLS) with Raman Spectroscopy provides the ability to extract a wealth of chemical, structural, and physical information about biotherapeutic proteins under formulation conditions.
Automation > Laboratory Instrumentation > White Papers
Using Laser Diffraction Particle Size Data to Optimise the Performance of Sprays
| By Malvern Instruments
Many industries share the need to closely control the characteristics of sprays, albeit for very different reasons, and one of the most critical parameters is the particle size of the droplets within the spray plume.
Automation > Laboratory Instrumentation > White Papers
Developing a Bioformulation Stability Profile
| By Malvern Instruments
When used in combination, light scattering and microcapillary viscometry can be used to develop a stability profile to screen biotherapeutic candidates, with light scattering providing a suite of dilute solution properties and microcapillary viscometry providing analysis of viscosity even at high sample concentration.
Automation > Laboratory Instrumentation > White Papers
Real-Time Particle Sizing for Granulation Control
| By Malvern Instruments
This paper considers various granulation processes and the use of real-time particle size measurement in their optimisation, focusing on two different sizing methods: laser diffraction and the spatial filter technique (SFT).
Automation > Laboratory Instrumentation > White Papers
1-15 of 125 results