Thesis

An In Vitro Study on the Cleaning Validation Methods for the Determination of mRNA Vaccine Residue

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PT. Etana Biotechnologies Indonesia (or “Etana”) plans to produce mRNA vaccines on a large-scale
basis. To ensure product and batch qualities, it is imperative to implement the cleaning validation
program. Cleaning validation is a procedure which ensures that there are no residues of Active
Pharmaceutical Ingredients (APIs) left after the cleaning process. It is generally performed as part of
the current good manufacturing practice (cGMP) to maintain product quality. The cleaning validation
procedure for different types of residues should be established and developed beforehand. The
determination of residual matter in cleaning validation depends on two factors: the sampling
methods and the assay procedure. The two commonly used sampling methods in the determination
of residual matters are the swab sampling method and the rinse sampling method. Additionally, the
Quant-iT Ribogreen Fluorescence Assay is found to be the procedure that is generally applied for the
detection of RNA in solutions. Before these methods and procedure can be applied on site, a study
should be performed to ensure that the methods and procedures are suitable for its intended use.
The acceptance criteria for the recovery of the tested residue was set based on the Technical Report
No. 49 Points to Consider for Biotechnology Cleaning Validation where percentage (%) recovery of
the sample shall be >50%. The results of this study indicate that both sampling methods are suitable
for use (>50% sample recovered for both sampling methods). Further study involving the replications
and optimization of the methods are to be performed to ensure method validity.

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Availability

Detail Information

Series Title

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Call Number

BT 22-023

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)

mRNA residue
cleaning validation
swab sampling method
rinse sampling method

Specific Detail Info

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Statement of Responsibility

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Other version/related

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