Ketergantungan Indonesia terhadap impor bahan baku farmasi serta disrupsi rantai pasok global selama pandemi COVID-19 menegaskan urgensi penguatan kemandirian bioteknologi nasional, termasuk pengembangan vaksin berbasis messenger RNA (mRNA). Namun, implementasi teknologi ini di Indonesia menghadapi tantangan multidimensional, khususnya kewajiban penerapan Sistem Jaminan Produk Halal (SJPH) sebagaimana diatur dalam Undang-Undang Nomor 33 Tahun 2014. Kompleksitas proses produksi vaksin mRNA yang bersifat cell-free, penggunaan bahan sintetis dan rekombinan, serta rantai pasok global menimbulkan tantangan dalam pemenuhan kriteria halal. Penelitian ini bertujuan untuk menganalisis implementasi SJPH dalam proses produksi vaksin berbasis teknologi mRNA di PT X, mengidentifikasi titik kritis halal yang muncul, serta menganalisis strategi penyesuaian yang dilakukan perusahaan dalam menyelaraskan tuntutan teknis bioproses dengan persyaratan halal. Penelitian ini menggunakan pendekatan kualitatif dengan desain studi kasus tunggal. Data dikumpulkan melalui wawancara mendalam, telaah dokumen, dan observasi, kemudian dianalisis menggunakan kerangka Teori Difusi Inovasi Rogers. Hasil penelitian menunjukkan bahwa PT X berhasil mengintegrasikan 11 kriteria SJPH ke dalam sistem manajemen mutu perusahaan melalui strategi integrasi struktural, pendekatan ilmiah dalam seleksi bahan baku, serta digitalisasi sistem ketertelusuran. Titik kritis halal utama ditemukan pada bahan baku seperti plasmid DNA, enzim, etanol, dan lipid nanoparticles, serta pada penggunaan fasilitas bersama pada tahap fill and finish. Strategi penyesuaian yang diterapkan memungkinkan pemenuhan persyaratan halal tanpa mengorbankan mutu dan integritas teknologi mRNA. Penelitian ini memberikan kontribusi empiris bagi pengembangan implementasi SJPH pada industri biofarmasi berteknologi tinggi di Indonesia.

Indonesia’s heavy dependence on imported pharmaceutical raw materials, combined with global supply chain disruptions during the COVID-19 pandemic, has underscored the urgency of strengthening national biotechnology self-reliance, particularly in the development of messenger RNA (mRNA) vaccines. However, the implementation of mRNA vaccine technology in Indonesia faces multidimensional challenges, notably the mandatory application of the Halal Product Assurance System (Sistem Jaminan Produk Halal/SJPH) as stipulated in Law No. 33 of 2014. The complexity of mRNA vaccine production, which involves cell-free bioprocesses, synthetic and recombinant materials, and globally distributed supply chains, poses significant challenges in meeting halal compliance requirements. This study aims to analyze the implementation of the Halal Product Assurance System in the mRNA vaccine production process at PT X, to identify critical halal control points, and to examine the adjustment strategies adopted to reconcile advanced biotechnological processes with halal requirements. A qualitative approach with a single-case holistic study design was employed. Data were collected through in-depth interviews, document review, and observation, and analyzed using Rogers’ Diffusion of Innovation theory as the analytical framework. The findings indicate that PT X has successfully integrated the 11 SJPH criteria into its quality management system through structural integration, a science-based approach to raw material selection, and the digitalization of traceability systems. Key halal critical points were identified in raw materials, including plasmid DNA, enzymes, ethanol, and lipid nanoparticles, as well as in the use of shared facilities during the fill-and-finish stage. The adjustment strategies implemented enabled halal compliance without compromising product quality or the technological integrity of mRNA vaccines. This study provides empirical insights into halal assurance implementation in high-technology biopharmaceutical industries and offers practical implications for industry stakeholders and regulators in developing adaptive halal governance frameworks for advanced biotechnology