Thesis

Optimization of Preparation Method for EPO Residue Determination in Sharing Facility

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Background – PT. Etana Biotechnologies Indonesia is planning to produce recombinant human erythropoietin (rhEPO). After the production process, the residue determination shall be conducted to check the presence of residue preventing cross-contamination between batches. The study will focus on EPO residue determination where the swab method will be optimized to determine the residual amount of EPO.
Objective – This project aims to optimize the swab method, verify the analytical method, and ensure the recovery amount of EPO residue fulfills the acceptance criteria.
Methodology – The study was conducted according to the purpose of each experiment. The optimization process involved EPO diluent preparation, sample preparation, sample dilution, and ELISA assay.
Result and Discussion – The swab pattern affects the amount of EPO residue recovered from the study. The texwipe pattern is selected due to the consistency of data among other patterns. EPO residue was found to be extractable from the SS304 plate. The data consistency, repeatability, and intermediate precision of the EPO residue determination were confirmed and verified. The analytical method is applicable for EPO residue determination in real conditions, i.e., the production facility.
Conclusion and Recommendation – Based on the experiment, the swab method has been optimized following the texwipe pattern. The result provided repeatable data in repeatability analysis. The RSD value was found to be satisfactory in intermediate precision analysis. The analytical method is suitable for quantifying EPO residual amount in real conditions, i.e., the production facility. The swabber should be trained prior to perform the swabbing process to ensure the data reliability.

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Availability

Detail Information

Series Title

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Call Number

BT 22-007

Publisher

i3L, Jakarta : i3L, Jakarta., 2022

Collation

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Language

English

ISBN/ISSN

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Classification

NONE

Content Type

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Media Type

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Carrier Type

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Edition

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Subject(s)

Erythropoietin (EPO)
PT. Etana Biotechnologies Indonesia
EPO for Injection
EPO leftovers
Enzyme-linked immunosorbent assay (ELISA)
TX715
SS304
Repeatability
Intermediate precision

Specific Detail Info

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Statement of Responsibility

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