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Case Study on Quantitation and Characterization of
Polysorbate-80 in Drug Formulations
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Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors.
Download this case study to learn the following:
- Challenges associated with the heterogeneous nature of PS-80 when used as an excipient
- Strategies to quantitate and characterize PS-80
- How this combined approach can measure PS-80 stability and homogeneity
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Q&A on Strategies to Remove Formulation Development from the Critical Path
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Biopharmaceuticals are highly unstable, and formulation development is required to ensure drug product quality and stability during manufacturing, storage and clinical administration. Further, formulation development is often on the critical path at risk of delaying IND and BLA fillings.
Download
this Q&A with Dr. Jun Lu, Director, Analytical Development to learn the following:
- How automation can be leveraged to remove formulation development from the critical path
- Strategies to overcome challenges associated with ranking protein stability
- Where instruments such as the Uncle platform can be used during the process
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Learn About Development & Drug Substance
Biomanufacturing Services at Catalent
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Catalent Biologics’ development services span drug substance, drug product and analytical leveraging advanced technology and proven expertise.
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Catalent Biologics’ two state-of-the-art biomanufacturing facilities have been designed to provide integrated bulk drug substance services for clinical trials and commercial supply.
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| Every molecule has a challenge. We have a solution. |
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| or call +1 877 891 9609 to speak with one of our experts today! |
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For more information call +1-866-720-3148 or in Europe 00800 88 55 6178, email us at sales@catalent.com, or visit our website www.catalent.com.
And to learn more about Career opportunities across our global network, visit www.catalent.com/careers.
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Links to third party sites are provided as a convenience only. Catalent makes no representation or warranty about the technology, security or any content available at these sites. Links are not intended to imply Catalent's affiliation or endorsement or the website, its owner(s) or the content. |
| © 2019, Catalent Pharma Solutions, Inc. 14 Schoolhouse Road, Somerset, NJ 08873. All rights reserved. |
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