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Whether developing new, ground breaking drugs or generic formulations, both the time and cost associated with pharmaceutical development is significant.
Malvern is focused on providing well designed, innovative analytical instruments, which follow the QbD (Quality by Design) ethos, in the fields of drug discovery, chemical and formulation development and pharmaceutical manufacturing.
Malvern can help with many aspects of QbD implementation; providing measurement technologies which have been designed, developed and tested following QbD principles, providing instruments, software and documentation to facilitate rapid method development, validation and transfer. We understand analytical instrument deployment and on-going support in a regulated environment to help you save time and money in bringing your product to market.
We understand what is involved in the development and manufacture of a drug product and the requirements to measure the Critical Material Attributes and Critical Quality Attributes (CQAs) affecting the Critical Process Parameters (CPP) in the manufacturing process.
Malvern’s value is in the breadth of characterization tools and application understanding that can be used to help accelerate pharmaceutical development. Malvern can implement systems that provide information on several Critical Material Attributes (CMAs) in one analysis, such as particle size, shape, and chemical identity or molecular weight, size and concentration. Whether characterizing the particle size and morphological properties of a novel Active Pharmaceutical Ingredient (API) or the suspension stability or rheological attributes of an New Chemical Entity (NCE), work flow efficiencies can be achieved when common platform technologies are utilized.
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This demo at your desk webinar will provide a real-time overview of the operation of the NanoSight NS300 for nanoparticle size and concentration measurements using Nanoparticle Tracking Analysis (NTA). You will see the instrument and software perform...
Significant advances have been made in analytical technology for the characterization and identification of particles present in pharmaceutical products. With these advances comes a tremendous amount of new data with which to characterize biologics, ...
Correctly targeting a drug product’s delivery location and defining its release profile are critical challenges and the subject of a great deal of research. The role of polymers in drug delivery applications is growing, with particular emphasis on ta...
In a recent newsletter, the US FDA highlighted the important role Morphologically-Directed Raman Spectroscopy (MRDS) can play in supporting the development of generic drug products. The component-specific particle size and shape distribution data gen...
Liposomes have been widely used as model membranes and in drug delivery, as their basic properties can easily be varied to target desired properties (lipid composition, concentration, water content, media (different buffers, varying ionic strength, p...
Using Isothermal Titration Calorimetry to support the development of therapeutic enzymes
(October 26 2016)
Nanoparticle size is an important criterion for our formulations and we routinely measure this with the Zetasizer Nano.
Good value and excellent performance is a combination that will warm the heart of any academic polymer scientist
Professor Kenneth J Wynne
the Department of Chemical and Life Science Engineering at Virginia Commonwealth University
The real benefit of the Viscotek system is the online viscometry detection and light scattering. These capabilities provide so much more info than conventional measurements, allowing you to look for polymer structure and branching as well as molecular weight and polydispersity.
Department of Chemistry and Faculty of Engineering, University of Georgia
We rely heavily on the Malvern HT-GPC system because of the comprehensive, accurate information it provides. Ongoing costs are low because the system is easy to maintain and consumables are affordable, which drives down the ‘cost per injection’, an important comparative indicator for us
Dr Jerome Claverie
NanoQAM, the nanotechnology research centre of the University of Quebec
The Morphologi G3-ID has proven straightforward and easy to use and we’ve already been successful in expanding our application of it into areas beyond construction materials.
Dr Ameneh Schneider
Association of the Austrian Cement Industry
Malvern’s Spraytec is designed to make droplet size distribution testing as easy as possible, and was the ideal solution for testing ADA’s new PFE under microgravity conditions.
For us, the Insitec is an essential tool for optimizing the performance of the finishing mills. It provides continuous particle size data, so that the operators can react quickly and confidently when making control decisions. As a result we have increased throughput and enhanced product quality.
Insitec brings value in three areas. It allows us to quantify differences in grindability, supports the development of an effective processing solution and improves the efficiency of our toll manufacturing, which is often a precursor to customer investment.
We appreciate the simple implementation of standard tests using the Kinexus and the intuitive design of complex measurement requirements. We also appreciate the outstanding support, and comprehensive advice and training that is available to us from Malvern Instruments.
Dr. Daniel Kessler
Steuler KCH Materials GmbH
Insitec is extremely reliable and enables us to provide milling plant for both wet and dry processing that efficiently meets customer goals for premium product quality and low energy consumption.
The images from the Morphologi G3 provided compelling evidence that the particles, rather than the sizing method, were a root cause of observed variability.
Reading Scientific Services Ltd
DSC is a useful tool to predict the protein stability at lower temperatures, screen buffers and excipients, screen therapeutic candidates and to predict protein aggregation.
DSC is a technology that is valuable in the early phases of protein characterization and formulation development. Critical data about protein stability can be rapidly acquired and used as a guide to support and speed up liquid formulation development projects.
Dr Fredrik Ollila
Novartis Pharma AG.
DSC rapidly determines the factors that contribute to antibody stability, and is a valuable stability indicating technique that can be applied throughout biotherapeutic development.
Stephen J Demarest
After just four months, the Morphologi G3-ID is already heavily used by researchers and students throughout the university. The automated microscopy and image analysis functions are especially popular and have saved countless hours compared with using manual microscopy techniques.
Southern Cross University
The software really is the shining star of the Mastersizer 3000. It makes it feel radically different from other systems on the market and a really great instrument to use. I especially like the live trends which make it so quick and easy to compare data sets.
NSL Analytical Services
Throughout the research and purchasing process, we assessed at least five to six different systems before selecting the Mastersizer 3000.
We can switch between different product grades around three to nine times faster than when we only had offline Blaine measurements for plant control. This has had a major impact on plant throughput. Here we have found the Insitec essential for the production of high quality products.
Mr Thomas Schuster
The technical support that we’ve received has been a deciding factor in our decision to continue to work with Malvern. Malvern systems also provide the cutting-edge performance and reliability that we need.
Domino Printing Sciences plc
The Insitec systems are a trusted and integral part of our plant. Our view is that real-time data is invaluable when it comes to producing slag cements with comparable performance to conventional products.
We use software capabilities, which were originally developed by Malvern for pharmaceutical industry users, to apply and demonstrate the analytical rigor required for certification of our powders.
Dr. Robert Deffley
In a comparative assessment the Morphologi G3 delivered the perfect balance between speed of measurement, image resolution and price.
Malvern came recommended by colleagues in the industry but it was the features of the Mastersizer 3000 itself that sold us on the instrument. We’ve been running for a year now without any reliability issues and with minimal running costs. Most importantly we produce data that can be trusted.
All information supplied within is correct at time of publication.
Malvern Instruments pursues a policy of continual improvement due to technical development. We therefore reserve the right to deviate from information, descriptions, and specifications in this publication without notice. Malvern Instruments shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance or use of this material.
Malvern and the 'hills' logo, Bohlin, Gemini, Insitec, ISys, Kinexus, Mastersizer, Morphologi, Rosand, SyNIRgi, Viscotek and Zetasizer, are International Trade Marks owned by Malvern Instruments Ltd.