The art of making a comprehensive stability study
(2020) KASM01 20201Centre for Analysis and Synthesis
- Abstract
- There is a need for harmonisation of stability study designs of monoclonal antibodies. Monoclonal antibodies (mAbs) are widely used in treatments for various diseases. Like all drugs, their quality must be verified through stability studies. The ICH guidelines give general recommendations regarding stability studies of antibodies, and specifications should often be determined on a case-by-case basis. More detailed requirements may need to be defined to make better designed stability studies for mAbs. This report aims to produce a broader understanding of the parameters that should be included in mAb stability studies and give a proposal for a comprehensive stability study design. The information for this report was obtained through... (More)
- There is a need for harmonisation of stability study designs of monoclonal antibodies. Monoclonal antibodies (mAbs) are widely used in treatments for various diseases. Like all drugs, their quality must be verified through stability studies. The ICH guidelines give general recommendations regarding stability studies of antibodies, and specifications should often be determined on a case-by-case basis. More detailed requirements may need to be defined to make better designed stability studies for mAbs. This report aims to produce a broader understanding of the parameters that should be included in mAb stability studies and give a proposal for a comprehensive stability study design. The information for this report was obtained through literature studies including amongst other the ICH guidelines and several newly published articles regarding size-exclusion chromatography and its application in stability studies. The results showed that the existing guidelines regarding stability studies of biopharmaceutical are very general. Therefore, stability test focusing on the physicochemical stability of mAbs in clinical settings are often missed. This additional stability test can increase the understanding of the analyte and may facilitate the work of health personnel. Even though it is difficult to make a study design that fit all types of mAbs, there are opportunities for improvement in the guidelines as they are today in order to make a more comprehensive stability study design. In conclusion, there is a need for development in stability study designs regarding mAbs. To create more comprehensive stability studies new recommendation may have to be added that may contribute to a harmonisation of the stability study designs (Less)
- Popular Abstract
- Antibodies do not only exist in our body, but they can also be manufactured in laboratories and cell-factories. Monoclonal antibodies (mAbs) are the type of antibodies that are used in for drug development. Their high selectivity makes them very useful in cancer treatments, but they can be used for the treatment of a large repertoire of diseases such as rheumatoid arthritis and multiple sclerosis to mention a few.
It is of great importance that the drugs that reach the market are thoroughly controlled. They should fulfil the required quality standards set by The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) or by regional authorities such as the United States Pharmacopeial... (More) - Antibodies do not only exist in our body, but they can also be manufactured in laboratories and cell-factories. Monoclonal antibodies (mAbs) are the type of antibodies that are used in for drug development. Their high selectivity makes them very useful in cancer treatments, but they can be used for the treatment of a large repertoire of diseases such as rheumatoid arthritis and multiple sclerosis to mention a few.
It is of great importance that the drugs that reach the market are thoroughly controlled. They should fulfil the required quality standards set by The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) or by regional authorities such as the United States Pharmacopeial Convention (USP) and the European Medicines Agency (EMA). To control an antibody’s quality, stability studies are performed. These studies should be well designed and cover all stability issues that may arise. Because, if some parameters are missed, they could lead to severe consequences for the patient, or even death.
Clear standards for study designs may help to avoid unnecessary consequences by contributing to well-designed stability studies. Recently, a study found that many companies do not perform sufficiently thorough stability studies regarding mAbs. Most studies focus only on fulfilling the stated regulations by the authorities. Tests for stability in a clinical setting, such as accidental shaking of the container, short term temperature changes during transportation or accidental breaking of sterility, are often missed.
The objective of this work was therefore firstly, to define what is required today for a stability study based on guidelines and recent literature. Secondly, to propose an example of what a comprehensive, well-designed stability study for mAbs should include, based on the studied literature.
It was found that there is a need for standardised comprehensive stability study designs for mAbs. Also, it is important to understand the characteristics of the studied protein to be able to perform better studies. In order to create more comprehensive stability studies new recommendation may have to be added to the guidelines, which may contribute to a harmonisation of the stability study designs. (Less)
Please use this url to cite or link to this publication:
http://lup.lub.lu.se/student-papers/record/9032242
- author
- Lord, Roman LU
- supervisor
- organization
- alternative title
- Presenting the development in size-exclusion chromatography analysis of mAbs and the requirements for a comprehensive stability study.
- course
- KASM01 20201
- year
- 2020
- type
- H2 - Master's Degree (Two Years)
- subject
- keywords
- Biopharmaceuticals, mAbs, SEC, stability study design, technical analytical chemistry, teknisk analytisk kemi
- language
- English
- id
- 9032242
- date added to LUP
- 2020-12-18 17:01:20
- date last changed
- 2020-12-18 17:01:20
@misc{9032242,
abstract = {{There is a need for harmonisation of stability study designs of monoclonal antibodies. Monoclonal antibodies (mAbs) are widely used in treatments for various diseases. Like all drugs, their quality must be verified through stability studies. The ICH guidelines give general recommendations regarding stability studies of antibodies, and specifications should often be determined on a case-by-case basis. More detailed requirements may need to be defined to make better designed stability studies for mAbs. This report aims to produce a broader understanding of the parameters that should be included in mAb stability studies and give a proposal for a comprehensive stability study design. The information for this report was obtained through literature studies including amongst other the ICH guidelines and several newly published articles regarding size-exclusion chromatography and its application in stability studies. The results showed that the existing guidelines regarding stability studies of biopharmaceutical are very general. Therefore, stability test focusing on the physicochemical stability of mAbs in clinical settings are often missed. This additional stability test can increase the understanding of the analyte and may facilitate the work of health personnel. Even though it is difficult to make a study design that fit all types of mAbs, there are opportunities for improvement in the guidelines as they are today in order to make a more comprehensive stability study design. In conclusion, there is a need for development in stability study designs regarding mAbs. To create more comprehensive stability studies new recommendation may have to be added that may contribute to a harmonisation of the stability study designs}},
author = {{Lord, Roman}},
language = {{eng}},
note = {{Student Paper}},
title = {{The art of making a comprehensive stability study}},
year = {{2020}},
}