Dewi, Yuanita Kumala (2020) Perancangan Strategi Mitigasi Risiko Pada Proses Kultur Sel Produksi Protein Rekombinan Dengan Metode House of Risk. Masters thesis, Institut Teknologi Sepuluh Nopember.
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Abstract
Kontaminasi mikroba, ketidakstabilan pada yield produksi dan cell line merupakan tantangan yang harus dihadapi industri bioteknologi farmasi ketika melakukan kultur sel sebagai salah satu tahapan proses produksinya. Seperti kasus yang dialami PT ABC yang telah mengalami kontaminasi mikroba sebanyak dua kali dalam proses kultur sel untuk produk protein rekombinannya. Total kerugian yang dialami akibat kontaminasi mikroba pada PT ABC sebesar 3,05 milyar rupiah dan berdampak pada terganggunya stok bahan obat protein rekombinan yang merupakan bahan baku obat untuk produk injeksi utama. Untuk itu, sangat diperlukan strategi mitigasi yang efektif untuk menangani beberapa risiko pada proses kultur sel yang saat ini belum diformulasikan oleh perusahaan. Penelitian ini bertujuan untuk merancang strategi mitigasi risiko pada proses kultur sel dengan metode House of risk (HOR). Terdapat dua matrix HOR yang digunakan pada penelitian ini. HOR1 digunakan untuk menentukan agen risiko mana yang harus diprioritaskan untuk tindakan pencegahan. Pada HOR2 akan dipilih beberapa strategi penanganan risiko yang efektif. Hasil penelitian menunjukkan terdapat 40 risiko dengan 31 agen risiko yang telah teridentifikasi. Berdasarkan hasil identifikasi, dipilih dua agen risiko yang akan dilakukan perancangan strategi penanganan. Terdapat enam tindakan proaktif yang diusulkan untuk strategi penanganan agen risiko dalam proses kultur sel produksi protein rekombinan di PT ABC.
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Microbial contamination, instability in production yields and cell lines are the challenges that must be faced by the pharmaceutical biotechnology industry when conducting cell culture as one of the stages of its production process. Such is the case of PT ABC, which has been twice contaminated with microbes in the process of cell culture for its recombinant protein products. The total losses suffered due to microbial contamination at PT ABC amounted to 3.05 billion rupiah and resulted in disruption of the stock of recombinant protein drug ingredients which are the active pharmaceutical ingredient for major injection products. For this reason, effective mitigation strategies are needed to deal with the risk in the cell culture process. This study aims to design a risk mitigation strategy for risk in cell culture process using House of Risk (HOR) method. There are two HOR matrices used in this study. HOR1 is used to determine which risk agents should be prioritized for prevention. In HOR2, several effective risk management strategies will be chosen. The results showed there were 40 risks events and 31 risk agents identified. Based on the identification results, two risk agents were selected to be designed for the strategy risk control. There are six proactive actions proposed for the risk mitigation strategy in cell culture process of recombinant protein production in PT ABC.
| Item Type: | Thesis (Masters) |
|---|---|
| Uncontrolled Keywords: | Mitigasi Risiko, House of Risk, HOR1, HOR2, Risk Mitigation |
| Subjects: | H Social Sciences > HD Industries. Land use. Labor > HD61 Risk Management T Technology > T Technology (General) > T174.5 Technology--Risk assessment. |
| Divisions: | Faculty of Creative Design and Digital Business (CREABIZ) > Technology Management |
| Depositing User: | Yuanita Kumala Dewi |
| Date Deposited: | 10 Aug 2020 04:46 |
| Last Modified: | 31 May 2023 07:06 |
| URI: | http://repository.its.ac.id/id/eprint/77378 |
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