Aggregation time machine
ǂa ǂplatform for the prediction and optimization of long-term antibody stability using short-term kinetic analysis
Abstract
Monoclonal antibodies are the fastest growing class of therapeutics. However, aggregation limits their shelf life and can lead to adverse immune responses. Assessment and optimization of the long-term antibody stability are therefore key challenges in the biologic drug development. Here, we present a platform based on the analysis of temperature-dependent aggregation data that can dramatically shorten the assessment of the long-term aggregation stability and thus accelerate the optimization of antibody formulations. For a set of antibodies used in the therapeutic areas from oncology to rheumatology and osteoporosis, we obtain an accurate prediction of aggregate fractions for up to three years using the data obtained on a much shorter time scale. Significantly, the strategy combining kinetic and thermodynamic analysis not only contributes to a better understanding of the molecular mechanisms of antibody aggregation but has already proven to be very effective in the development and production of biological therapeutics.
Keywords
mAb;monoklonska protitelesa;formulacije;agregacija;monoclonal antibody;formulation;aggregation;
Data
| Language: | English |
|---|---|
| Year of publishing: | 2022 |
| Typology: | 1.01 - Original Scientific Article |
| Organization: | UL FKKT - Faculty of Chemistry and Chemical Technology |
| UDC: | 577.322 |
| COBISS: |
97795331
|
| ISSN: | 0022-2623 |
| Views: | 115 |
| Downloads: | 41 |
| Average score: | 0 (0 votes) |
| Metadata: |
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Other data
| Secondary language: | Slovenian |
|---|---|
| Secondary keywords: | mAb;monoklonska protitelesa;formulacije;agregacija; |
| Type (COBISS): | Article |
| Pages: | str. 2623-2632 |
| Volume: | ǂVol. ǂ65 |
| Issue: | ǂiss. ǂ3 |
| Chronology: | 10 Feb. 2022 |
| DOI: | 10.1021/acs.jmedchem.1c02010 |
| ID: | 15427844 |
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