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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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Adeno-Associated Viral Titer in minutes, using Nanoparticle Tracking Analysis (NTA) Webinar - Live (English)

• 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...

Product:
NanoSight range
Date:
June 7 2016
Language:
English


Silicone oil-induced protein aggregation and immunogenicity Webinar - Live (English)

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. ...

Product:
Archimedes
Date:
May 31 2016
Language:
English


Using Taylor Dispersion Analysis to determine oligomeric state of insulin Article (English)

Taylor dispersion analysis is an emerging biophysical characterization technique that offers unique benefits in the early stages of biopharmaceutical development – providing answers that established techniques cannot effectively handle.



Biophysical characterization of epigenetic interactions and associated drug discovery, using Isothermal Titration Calorimetry Webinar - Recorded (English)

The term ‘epigenetics’ refers to changes in and regulation of gene expression and function, without alteration of DNA sequence. The mechanisms behind these changes involve “epigenetic regulator” proteins that interact with and modify chromatin (DNA w...

Product:
MicroCal ITC range
Date recorded:
April 26 2016
Language:
English


Applying Quality by Design to the manufacture of drug product for biopharmaceuticals Webinar - Recorded (English)

QBD is a term that is often spoken with respect to the production of biopharmaceuticals.  However, despite the issuance of guidance documents on this topic, it is still relatively poorly understood.  This discussion seeks to demystify the concept ...

Product:
NanoSight range,Archimedes
Date recorded:
April 19 2016
Language:
English

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Silicone oil-induced protein aggregation and immunogenicity
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