The Sanofi Hub at Malvern Panalytical
Contact information, training material and coverage of relevant Malvern Panalytical / Concept Life Sciences services and solutions
Contact information, training material and coverage of relevant Malvern Panalytical / Concept Life Sciences services and solutions
Malvern Panalytical are a leading provider of material characterization solutions within pharmaceutical, bio-pharmaceutical, vaccines and consumer health. This web hub will summarise what we can do (and what we already do) for you as a company, and also provide our existing users within your organization with the support material they need to do their day job.
| ||
| CFR 21 part 11, data integrity Quality Method services | ||
|---|---|---|
We have recently launched a new 21CFR and data integrity offering | ||
| Biologics | Vaccines | APIs |
Tools for the characterization, optimization and understanding of your large molecules | Tools for characterization of and formulation development of vaccines | Tools for characterization, optimization, delivery and understanding of active pharmaceutical ingredients & excipients |
| Foundations: support, training, brainstorming | ||
Find out how we are supporting you, and contact your local account team | ||
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.
This is part of our offering in Analytical Instrument Qualification.
The Mastersizer 3000 white papers/gap analysis can be downloaded below:
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.
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 us.
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.
