ResourceDrug discovery > Lead Discovery
Developing a Bioformulation Stability Profile
27 Feb 2014The ability to handle both low sample volumes and high sample concentrations makes the use of light scattering and microcapillary viscometry ideal for moving the biotherapeutic screening process, both in terms of prediction and confirmation, to earlier points in the development pipeline. This white paper describes the development of a bioformulation stability profile, derived from sub-micron light scattering analysis and microcapillary viscometry.
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Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.ViscometersViscometers are used to measure the viscosity of a fluid. Types of viscometer include rotational, vibrational and falling piston viscometers. Options for viscometers include modular, portable, benchtop and temperature compensation and density measurement features.Particle CharacterizationParticle characterization instruments are used to determine particle size distribution, shape, surface area, zeta potential, density and porosity of particles and materials. Multiple tecchniques are available for determining particle size, shape and count including dynamic light scattering (DLS), laser diffraction, electrozone (Coulter technique), imaging particle analysis and single particle optical sensing. Determine the density of your material with a gas pycnometer or examine its surface area and porosity with gas adsorption analyzers and mercury porosimeters. Find the best particle characterization instruments in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Drug DeliveryDrug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services. Scale-upScale-Up is generally defined as the process of transferring the results of the discovery phases of the drug discovery process, obtained on a laboratory scale, to the pilot plant and finally to production scale. Scale-Up uses reactors and pump systems as well as reagents, standards and buffers. Often Scale-Up is provided as a service by Contract Manufacturing Organizations (CMOs). FormulationFormulation is the process of combining active pharmaceutical ingredients with excipients to produce a drug which is both stable and active.BiotherapeuticsBiotherapeutics are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or in <i>in vivo</i> diagnostics. The most well-known example of a biotherapeutic product, and the first to be approved for therapeutic use, was recombinant human insulin.