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As market interest and investment in biopharmaceuticals surges and the requirement for novel, tailored biological drugs continues to grow, the industry is under increasing pressure to ensure delivery of therapies rapidly yet safely.
Biopharmaceutical development and manufacture, focusing on molecules such as monoclonal antibodies, recombinant proteins, vaccines and oligonucleotides, are lengthy and complex processes with very specific analytical challenges. We know that in order to successfully deliver a biotheraputic to market it is vital to reduce risk as soon as possible, deliver timely and accurate data and increase efficiency by streamlining processes and easing bottlenecks.
Malvern Instruments provides a growing range of solutions which are focused specifically on your critical path of testing and manufacturing requirements, and which take into account the pressures of time and cost along with such factors as sample availability and complexity. Our analytical toolbox for biopharmaceutical development is expertly tailored to provide tried and trusted solutions such as Viscotek size exclusion chromatographs to assess product purity and the Zetasizer range for sizing and zeta potential analysis for product stability, and also groundbreaking new technologies including the Viscosizer TD to assess bioformulation suitability and stability as early as late stage discovery activity, along with Archimedes and the Nanosight range of instruments to quantify early aggregation in bioformulations.
No one problem or product is the same, and our technical experts are always on hand to provide support and to work with you to find the right solution to your challenge. We pride ourselves on agile technology development, in partnership with our Bioscience Development Initiative. We are constantly looking for the next solution to enable quicker, easier and more useful and meaningful analysis. Together with our customers, we have created a suite of instruments which provide access to a raft of biophysical information on your product, to speed you through characterization studies, formulation development, quality control and beyond.
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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, ...
Understanding the stability of biological formulations – including their propensity to aggregate - is one of the primary requirements of moving drug candidates through the development pipeline. Biopharmaceutical companies will often establish a targe...
• Nanoparticle Tracking Analysis (NTA) Characterization of Gold-Labeled Adeno Associated Virus (AAV) and Other Small Viruses • NTA is an analytical tool that measures the size and concentration of virus particles. • NTA can measure virus titer in abo...
Prefilled syringes are often used for packaging and delivery of therapeutic proteins. But the silicone oil lubricant can cause protein aggregation and promote adverse immunogenicity. In this presentation, data on these two topics will be summarized. ...
Epigenetic regulation of genomic DNA for gene expression is important in cellular differentiation and the development of an organism. Epigenetics also contributes to human diseases. On a molecular level, epigenetics involves modification of the histo...
(Webinar - Recorded)
Rapid Generic Pharmaceutical Product Development
(July 12 2016)
Nanoparticle size is an important criterion for our formulations and we routinely measure this with the Zetasizer Nano.
My students have always had great things to say about the Zetasizer Nano. They say it’s very easy to use. The software is very user-friendly and it can accommodate particles of various different sizes, so I have never had reason to evaluate another particle sizing instrument.
Dr. Albena Ivanisevic
Department of Materials Science and Engineering at North Carolina State University
On-line zeta potential measurement is helping us to achieve a more cost-efficient water facility.
The Zetasizer Nano is so easy to use. All my students can familiarise themselves with it very quickly. As a result, we are purchasing a second instrument to ensure we have enough capacity for our expanding research programme in this area.
Department of Chemistry, at The University of Sheffield
Here at IU’s Nanocharacterization facility, the Malvern Zetasizer Nano is the ‘go to’ instrument for characterization of assembled product.
Dr Stella Aniagyei
Indiana University’s (IU) Molecular and Cellular Biochemistry Department
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
We very much value the customer service and training opportunities from Malvern. In particular, the rapid diagnosis of any issues through direct internet connection with the Malvern customer service team has prevented us from suffering production downtime.
Dr. Cordula Grüttner
micromod Partikeltechnologie GmbH
The big plus of an on-line instrument is real-time monitoring, the value of which was really brought home to us during a recent treatment event. The on-line data we collected during the event gave us new insight into a modified operating scheme that we’re now capitalizing on.
The Malvern systems have proved highly effective, allowing us to further demonstrate the stability and purity of our products and how this may be translated into improving liquid biopharmaceutical formulations.
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
The Malvern NanoSight NTA system allows us to directly and reliably quantify extracellular vesicle yields from the cell lines under investigation, which is critical to this project.
Ohio State University
With NTA we are able to sensitively monitor the behavior of a nanoparticle over time in a variety of different media.
Département Environnement et Agro-biotechnologies at the CRP - Gabriel Lippmann.
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
We’ve always been really happy with Malvern and while we’ve tried other companies, the necessary expertise was not there.
the IN-CTSI (Indiana-Clinical Translational Sciences Institute)
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
We have had several researchers become new NRC users because they want to access our Malvern Zetasizer Nano
the Nanotechnology Research Center (NRC) at the Georgia Institute of Technology
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
The [Zetasizer Nano] instrument is robust, easy to use and data acquisition is straightforward. It is as close to ‘student proof’ as it is possible to be!
Dr Krystelle Mafina
Queen Mary University
Throughout the research and purchasing process, we assessed at least five to six different systems before selecting the Mastersizer 3000.
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 Zetasizer Nano has reliably delivered a substantial portion of data and continues to help drive our research.
NTA is a relatively new addition to the lab but is already bringing value to several areas of research.
Malvern Instruments’ webinars, live chats and technical support are very useful and continue to help our researchers push the boundaries of materials and biomaterials science.
As part of the multi-disciplinary lab at QMUL, materials and biomaterials research groups throughout the university, from engineers and chemists through to biologists and physicists, are benefiting from access to analysis using the Zetasizer Nano.
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
One of the great things about the Nanoparticle Tracking Analysis system is the unique visualization capability which enables real time empirical insight into key particle behavior, such as the propensity and rate of aggregation, as opposed to alternative techniques with often lengthy procedures.
University of Wisconsin-Milwaukee
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.
We’ve been running the Zetasizer APS continuously since 2012 and the real beauty is that we simply load the samples in multiwell plates, leave it to run, even overnight, and go back and pick up the results.
Dr Maria Håkansson
Nanoparticle Tracking Analysis has provided us with an instantaneous way of looking at the behavior of the nanoparticles within a biological medium, providing insight unachievable with alternative analysis techniques.
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