The GlaxoSmithKline Hub at Malvern Panalytical

Download our training course material on all things to do with the Mastersizer 3000 (and 2000) and its data/results, designed for users from novice to intermediate/expert.

What will you learn?

• Basics of laser diffraction and data quality
  Learn how the instrument works and how to take a good quality measurement
  
  
• Optical properties and statistics
  Learn how to set the most appropriate refractive index choice and where it may be appropriate to use the Fraunhofer approximation and what all the parameters on the reports mean and which ones tell you most about your sample.
  
  
• Method development and troubleshooting
  How to develop both wet and dry methods on the Mastersizer and how to work out what is happening when unexpected data is reported.

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Virtual Workshop: Analytical strategies for novel therapeutic modalities

The classical toolbox for drug discovery is continuously expanding beyond small molecules. Novel therapeutic modalities have matured and demonstrated clinical success. The development of these biologics has posed new analytical challenges when ensuring their stability and activity. 

In this workshop, attendees will discover a range of analytical workflows that can be used to assess the stability and activity of novel therapeutic modalities These workflows include methods used to investigate physical and structural properties, as well as binding and formulation behavior. 

Examining and understanding these properties can help to improve the shelf life of biologics and improve the quality and robustness of subsequent research.

Find out more by downloading the presentations and watching the recording below:

• Presentation 1: Data Quality and its Impact on Decision-Making
• Presentation 2: Improved Methods For Fluorescent Labelling And Detection with Nanoparticle Tracking Analysis (NTA)
• Presentation 3: Advanced microcalorimetry - beyond Kd and Tm

We have recently launched a new 21CFR and data integrity offering (OmniTrust) for Aeris, Empyrean and the Zetasizer Advance series. To request a white paper on how this meets regulatory offerings (part 11 and ALCOA+) together with a FAQ that acts as a response to URS in this area please contact us at gsksupport@malvernpanalytical.com. 

This is part of our offering in Analytical Instrument Qualification. 

The Mastersizer 3000 white papers/gap analysis can be downloaded below:

• Mastersizer 3000 21 CFR Part 11 Gap Analysis
• Mastersizer 3000 Annex 11 - Computerised Systems - Gap Analysis

Additional services

Should you require any analytical services such as validated method transfer or method development, we would be delighted to discuss your needs.

There are many Malvern Panalytical solutions for different parts of the biologics workflow. Subjects range from peptides and recombinant proteins, enzymes, monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), bispecific antibodies and nucleic acids to viral vaccines, gene therapy vectors and cell therapies. 

From early development (challenges are activities such as developing the assays), formulation where the stability in solution is key and the challenge is optimizing this (controlling pH, temperature, salt concentration and adding stabilizers) through to QC and release (where the issues are checking quality is maintained and all batches are equivalent). 

DSC ,  ITC , GCI ,  DLS ,  NTA  and  SEC  can provide insight into your sample behavior.

Our solutions are used throughout the vaccines space. For looking at the particle size distribution of the particles including adjuvants, the thermal stability and sample homogeneity we have a solution. Viral titer can be measured by using MADLS or NTA.

There are many Malvern Panalytical solutions for different parts of the pharmaceutical development journey.

API development

In API development we can help you look at the polymorphic form or forms that are present and it's / their stability and what happens upon processing. We can also help you look at batch-to-batch variations.

X-ray diffraction ,  laser diffraction  and image analysis can help you gain an understanding about your material.

Formulation development

If you are in formulation development and optimization we can help you understand the stability and interactions of the components you are working with. The Zeta potential is an important measure of stability.

Manufacturing quality control

If you work in QA we can offer robust characterization tools in a regulated environment setting (and help with the validation). Understanding inter batch variation, achieving good process control and delivering reliable trustworthy data is what is important here.

If you require to speak to your account support team please email gsksupport@malvernpanalytical.com. For live chat please click here.

For Mastersizer support, the 2020 training slides are here. This 2 day course covered Mastersizer data quality, troubleshooting, maintenance, method development and method transfer.

For software downloads and release notes, the software can be downloaded from the Malvern Panalytical website. Please check with your local characterization team lead and IT before attempting to download software.

For key information on the impending obsolescence of the Mastersizer 2000 please click here or discuss with either your local Malvern Panalytical representative or TET contact.