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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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Applying complementary particle techniques for assessing comparability and biosimilarity of therapeutic products Webinar - Live (English)

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, ...

Product:
Archimedes,Zetasizer range,Viscotek SEC-MALS,Morphologi G3-ID,NanoSight range
Date:
September 20 2016
Language:
English


How multi-detector GPC/SEC can advance our understanding of drug delivery polymers Webinar - Live (English)

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 t...

Product:
Viscotek range,OMNISEC,Zetasizer range
Date:
September 6 2016
Language:
English


Rapid Generic Pharmaceutical Product Development Webinar - Recorded (English)

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...

Product:
Morphologi G3-ID
Date recorded:
July 12 2016
Language:
English


Using DSC to characterize thermotropic phase transitions in lipid bilayer membranes Application Note (English)

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...



Good practice for studying the stability of liposomes, their use as model systems and in drug delivery Webinar - Recorded (English)

Differential Scanning Calorimetry (DSC) studies of lipid thermotropic phase transitions: - Why use DSC for characterization? - What information does DSC provide? - The basics of liposome preparation – various techniques (membranes of a single l...

Product:
MicroCal DSC range
Date recorded:
June 29 2016
Language:
English

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2nd Annual European MicroCal Meeting

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Upcoming webinar

How multi-detector GPC/SEC can advance our understanding of drug delivery polymers
(September 6 2016)

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