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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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The optimization and scale up of high shear granulation: exploring the benefits of real-time particle sizing Article (English)

This article explains how a Parsum probe was used to monitor a granulation at three different scales to confirm that, in each case, the granules produced were the same size, and more importantly produced tablets of identical quality as quantified by ...

Demo at your desk - Particle sizing for the Pharma industry Webinar - Live (English)

This online demo is designed to provide you with an introduction to the Mastersizer 3000. You will be able to take a look at the Mastersizer 3000 and it’s accessories via the webcam in our lab, and we will share the Mastersizer 3000 software with you...

Mastersizer 3000
September 17 2015

Silver colloids and invisible ink Webinar - Live (English)

In the early history of cryptography and ciphers then invisible inks using silver salts and other chemicals were used. Silver colloids were regularly used and abused in this area. Silver colloids are now finding application (and legislation) as bater...

September 2 2015

Using GPC/SEC for excipient characterization Article (English)

The properties of polymeric excipients can directly affect the clinical efficacy, safety, and quality of a finished pharmaceutical product and are routinely identified as critical quality attributes (CQAs). This article looks at how gel permeation/si...

Keywords: English Article Molecular structure Molecular size Molecular weight Gel Permeation Chromatography Static Light Scattering Size Exclusion Chromatography Biological drug characterization and development Drug discovery Excipients and coatings OMNISEC 

Investigating the De-agglomeration profiles of DPI formulations Article (English)

Spraytec can measure how the particle size delivered by a dry powder inhaler (DPI) changes as a function of applied air flow rate, providing a deagglomeration profile which can be used to compare the performance of different formulations in a device ...

Keywords: English Article Spraytec Particle size Pharmaceutical formulation and development 
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Silver colloids and invisible ink
(September 2 2015)

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