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Förslaget inkom 2012-01-27

Exam-work -Comparability and integrity of biopharmaceuticals

OBS! ANSÖKNINGSTIDEN FÖR DETTA EXJOBB HAR LÖPT UT.
This 20 week (30hp) exam-work has the goal of investigating the value of Biacore based techniques as rapid and confident methods for characterization of protein integrity and comparability.

The integrity and comparability are important characteristics on the quality and safety of a biopharmaceutical (BPh) drug. The different epitopes of a BPh can be characterized by measuring the interaction with monoclonal antibodies (Mab) and natural ligands (that in the case of Abs include FC-receptors). Using different Biacore systems up to 16 antibodies can be attached to the chip and binding kinetics and active concentrations with the BPh can be measured simultaneously. This multivariate active concentration and binding kinetic fingerprint of the different epitopes of the BPh can be seen as a measure of integrity and comparability. These measurements can also be performed using different designed (DOE) running buffers and compared with other biosimilars to further increase the resolution of comparability and integrity studies.

The work comprises of identifying/selecting and ordering a set of reagents, developing assays for kinetics and active concentration measurement, analyzing a set of native and modified BPh using both small and larger variations in buffer composition. The work ends with an extensive analysis of data using graphical and multivariate statistical methods and documentation in report/poster/publication.

We will evaluate applications directly as we get them. The goal is to get the project staffed and started as soon as possible – latest in the beginning of February.

Qualifications/Requirements:
2-3 Year studies of chemistry with biochemistry and/or biotechnology as main focus.

Desired Characteristics:
- Good laboratory skills.
- Fluent in working with proteins.
- Interest in analyzing multivariate data.

For further information, please contact:

Markku Hämäläinen +46(0)18-675761

markku.hamalainen@ge.com

Apply to the position through this link: http://jobs.gecareers.com/job/Uppsala-Exam-work-Comparability-and-integrity-of-biopharmaceuticals-Job/1666299/



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