Active Pharmaceutical Ingredients
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United Kingdom

Malvern Panalytical

Pharmaceutical analytic experts

Malvern Panalytical

Analytical technologies to speed pharmaceutical development and manufacture

Malvern Panalytical designs and develops innovative analytical instruments which measure parameters including particle size, shape and concentration, chemical identity, zeta potential, protein charge, molecular weight, mass and conformation, biomolecular interactions and stability, rheological properties, elemental concentrations and crystallographic structures. Highly reliable and robust characterization of these properties is fundamental to predicting how a product will behave during use, to optimizing its performance and achieving manufacturing excellence. We aim to be a top supplier in Pharmaceutical analytic experts.

Our technologies are used globally throughout the pharmaceutical industry in the fields of chemical development, deformulation, formulation development, and manufacturing. Our instruments help solve the challenges associated with maximizing productivity, developing safer and more effective pharmaceutical products and getting them to market faster.

Malvern Panalytical was formed by the merger of the businesses Malvern Instruments and PANalytical on 1st January 2017 and employs over 2,000 people worldwide.

Mastersizer: The World’s most popular particle size analyzer

The Mastersizer range of laser diffraction particle size analyzers, including our flagship Mastersizer 3000, sets the standard for delivering rapid, accurate particle size distributions for emulsions, suspensions and powders.

From assessing product uniformity and solubility, through to optimizing packing density to improve final product performance and controlling powder flowability to increase manufacturing efficiency, particle size analysis is critical to understanding and controlling a wide range of properties. The Mastersizer range, with its intuitive software and industry-leading design and ergonomics, enables all users to make fast and accurate particle size distribution measurements, supporting product development and quality control applications.

Pharmaceutical analytic experts

The Mastersizer 3000 is the latest generation of the World’s most popular particle sizing instrument. Incorporating expert engineering and applications know-how into every stage of its design, it delivers:

  • Broad particle size range, from 0.01 μm to 3500 μm
  • Class-leading particle sizing performance in a compact footprint
  • Intuitive software with built-in expertise to ease your workload
  • Flexible reporting to display your data the way you want it
  • Rapid and effective wet dispersion
  • Fast, reliable particle size measurement of fragile and cohesive dry powders
  • Mastersizer know-how throughout, for results you can rely on
  • Data integrity assured through 21 CFR Part 11 compliant software features

A must-have instrument in the pharmaceutical industry” – Jignesh Desai, Alvogen

www.malvernpanalytical.com/mastersizer

Morphologi: automated imaging for advanced particle characterization

Morphological imaging is fast becoming an essential technology in the laboratory toolset for particle characterization. Providing automated, rapid, and component-specific morphological information, Morphologi systems help solve formulation and deformulation challenges, optimize material properties, and create confidence throughout development and manufacturing. These systems enable process control and optimization and provide quick identification of the cause of process deviations. We offer a top experience in Pharmaceutical analytic experts.

Morphologi 4 is a fully-automated static image analysis system which provides a complete detailed description of the morphological properties of particulate materials. Morphologi 4-ID offers an exclusive Morphologically-Directed Raman Spectroscopy (MDRS®) capability, combining all the benefits delivered by the Morphologi 4 with chemical identification of individual particles by Raman spectroscopy in a single measurement, to provide component-specific morphological descriptions of chemical species within a blend.

Active Pharmaceutical Ingredient (API) and excipient particle size and shape are critical material attributes which must be understood and controlled during formulation development and process scale-up for both innovator and generic products. Morphologi delivers the data required to achieve this and can also determine the component-specific API particle size required to establish in vitro bioequivalence for generics, minimizing associated clinical study costs.

  • Broad particle size range, from 0.5 μm to over >1300 μm
  • 20+ morphological parameters deliver a highly-detailed description of your particulate material
  • Integrated dry powder dispersion unit for reproducible sample dispersion
  • Dedicated sample presentation accessories enable measurement of a wide variety of sample types, including suspensions and filters
  • Automatically measures Raman spectra for hundreds or thousands of
    particles, saving valuable analyst time
  • Easy correlation of morphological properties with chemical information provides comprehensive understanding of your sample
  • 21 CFR Part 11 software option ensures regulatory compliance

 The Morphologi ID system has truly been invaluable to our particle characterization core facility. This instrument is the one instrument that provided the answer to ‘what is it?’ when characterizing particles“– Amber Fradkin, KBI Biopharma

 www.malvernpanalytical.com/morphologi

MicroCal PEAQ-DSC: The gold standard for protein stability analysis

MicroCal PEAQ-DSC microcalorimeters are powerful tools which enable characterization of the thermal stability of proteins and other biomolecules, primarily for biopharmaceutical development and manufacture. In solution, these molecules often undergo thermally-induced conformational changes, such as the breaking of non-covalent bonds leading to the unfolding of a protein. These types of structural rearrangement are detectable by DSC as they require the absorption of energy in the form of heat. Even in dilute solutions of protein, the new MicroCal PEAQ-DSC systems detect such heat changes and use them to accurately characterize the thermal stability of the molecule under analysis.

DSC analysis allows rapid identification of conditions that deliver optimum stability. The streamlined workflow and automated data analysis provided by MicroCal DSC systems accelerate screening of typical formulations and purification conditions, quickly delivering reliable results with minimum hands-on time, and driving productivity in research and development. The best experience to be had in Pharmaceutical analytic experts.

MicroCal PEAQ-DSC instruments are used for general stability studies, for biosimilarity and batch-to-batch comparability assessment and for the optimization of purification and manufacturing conditions. They are simple to use, requiring little assay development, and no labelling or immobilization.

Our instruments are operated by MicroCal PEAQ-DSC software, containing the following four specialist modules:

  • PEAQ-Compliance – for 21 CFR Part 11 compliant operation and data analysis
  • PEAQ-Performance – to ensure optimal system operation
  • PEAQ-Smart (including PEAQ-Finder) – for SOP-based operation and automated analysis
  • PEAQ-Compare – for the direct comparison of DSC thermograms, between molecules and between batches

 We routinely use DSC as the ‘gold standard’ for protein stability studies and encourage our researchers to determine melting points with DSC first” – David Staunton, Oxford University

 www.malvernpanalytical.com/microcal

Empyrean: The intelligent X-ray diffractometer

X-ray powder diffraction, a rapid non-destructive analytical technique, is widely applied in drug discovery, formulation, stability testing and final product quality control. With the 3rd generation Empyrean, this proven and comprehensive analytical method is available with 21 CFR Part 11 Audit Trail support. We give a top service due to our high experience in Pharmaceutical analytic experts.

Empyrean has the unique ability to measure all sample types – from powders to thin films, from nanomaterials to solid objects – on a single instrument, and its newly-designed MultiCore Optics enable the largest variety of measurements without manual intervention, including high-throughput measurements on multiwell plates.

Empyrean covers the largest set of X-ray diffraction, scattering and imaging applications in one single instrument. It is ideal for teaching purposes, thanks to the large doors that open completely, allowing simultaneous access to the system to several people, and is equally well-placed to perform measurements in demanding pharmaceutical R&D environments.

If I moved to another company and have chance to purchase, Empyrean would be the one” – Raeann Wu, Teva Pharmaceuticals

www.malvernpanalytical.com/empyrean

Pharmaceutical analytic experts – Zetasizer Ultra: The World’s most advanced light scattering system

The Zetasizer Ultra is our most advanced system for the measurement of particle and molecular size, particle charge and particle concentration, and represents the most intelligent and flexible instrument in the Zetasizer range.

The correct particle size and zeta potential helps ensure the production of effective therapeutics, delivered safely. Zetasizer systems are used to characterize the stability and quality of dispersions, emulsions and creams, reducing formulation time and speeding new products to market. We want you to have the best experience to see us as Pharmaceutical analytic experts.

Biological molecule stability can be impacted by variations in concentration, external temperature, agitation and the passage of time. Instabilities may result in the denaturation and aggregation of biologics, leading to loss of function, limited therapeutic viability and the potential of unwanted immune response. The Zetasizer Ultra rapidly provides high quality, stability-indicating data for biological molecules, enabling this measurement to be implemented throughout the development pipeline. We will become a top supplier in Pharmaceutical analytic experts.

The Zetasizer Ultra is the world’s most capable combined DLS and ELS system, incorporating Non-Invasive Back Scatter (NIBS®) and, uniquely, Multi-Angle Dynamic Light Scattering (MADLS®) technology for the measurement of particle and molecular size. NIBS provides the versatility and sensitivity to measure over a wide concentration range, while MADLS permits a higher resolution view into your sample’s size distribution for those critical measurements.

An extension to MADLS affords the ability to directly analyze particle concentration. The measurement of particle concentration is calibration-free, suitable for a wide range of materials, requires no or little dilution, and is quick to use – all of which make it ideal as a screening technique.  This is a unique capability of the Zetasizer Ultra which can even be applied to samples such as viruses and VLPs, which were previously very challenging to measure.

  • Dynamic Light Scattering (DLS) measures particle and molecule size, from below 1 nm to 10 µm
  • Electrophoretic Light Scattering (ELS) measures the zeta potential of particles and molecules, indicating sample stability and/or propensity to aggregate
  • Non-Invasive Back-Scatter (NIBS) optics for versatile, high sensitivity, particle and molecular size measurements

http://www.malvernpanalytical.com/zetasizer

Our Zetasizer has been imperative in allowing me to analyze my drug-loaded polymeric nanoparticle formulation batches with consistent results. The instrument is easy to use and allows for numerous analytical combinations” – Jessica Castaneda-Gill, University of North Texas Health Science Center

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