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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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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


The Power of Heat: Digging Deeper with Differential Scanning Calorimetry to Study Key Protein Characteristics Webinar - Live (English)

Differential Scanning Calorimetry (DSC) has a long history of playing a vital role in biopharmaceutical development. From candidate selection to formulation development, stability monitoring and bio-similarity assessment, DSC remains one of the top a...

Product:
MicroCal DSC range
Date:
August 16 2016
Language:
English


The role of Taylor Dispersion Analysis in assessing the stability of biological formulations Webinar - Recorded (English)

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...

Product:
Viscosizer TD
Date recorded:
July 26 2016
Language:
English


Characterization of biopharmaceutical stability with Differential Scanning Calorimetry: Candidate selection for developability Whitepaper (English)

Biopharmaceutical proteins are characterized and optimized for stability throughout development. Differential scanning calorimetry (DSC) is a key biophysical assay used to rank order thermal stability. This white paper discusses how DSC is used to se...



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...


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The Power of Heat: Digging Deeper with Differential Scanning Calorimetry to Study Key Protein Characteristics
(August 16 2016)

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