Tantangan Teknis dalam Peningkatan Skala Produksi dan Standardisasi Terapi Bebas Sel Berbasis Sekretom: Sebuah Tinjauan Pustaka

Akbar Kurniawan; Tjandra Yoga Aditama; Kamal Anas; Restu Syamsul Hadi

doi:10.69693/ijmst.v4i2.9466

Authors

Akbar Kurniawan Universitas YARSI
Tjandra Yoga Aditama Universitas YARSI
Kamal Anas Universitas YARSI
Restu Syamsul Hadi Universitas YARSI

DOI:

https://doi.org/10.69693/ijmst.v4i2.9466

Keywords:

Sekretom, Terapi Bebas Sel, Vesikel Ekstraseluler, Eksosom, Peningkatan Skala Produksi, GMP

Abstract

Perkembangan kedokteran regeneratif pada saat ini telah meningkatkan minat terhadap terapi bebas sel berbasis sekretom sebagai alternatif menjanjikan untuk terapi sel punca konvensional. Sekretom mengandung berbagai molekul bioaktif, termasuk faktor pertumbuhan, sitokin, vesikel ekstraseluler (EV), dan eksosom, yang berkontribusi pada regenerasi jaringan, angiogenesis, imunomodulasi, dan regulasi inflamasi. Terlepas dari potensi terapeutiknya, translasi klinis dari terapi sekretom masih terbatas oleh beberapa tantangan teknis, khususnya dalam produksi skala besar dan standardisasi produk. Tinjauan pustaka ini bertujuan untuk mengidentifikasi tantangan utama dalam peningkatan skala produksi dan standardisasi terapi bebas sel berbasis sekretom serta mengevaluasi strategi optimasi saat ini yang mendukung aplikasi klinis dan industri. Literatur dikumpulkan dari PubMed, Scopus, ScienceDirect, SpringerLink, dan Google Scholar menggunakan pendekatan tinjauan naratif. Hasil tinjauan pada penelitian ini menunjukkan bahwa variabilitas donor, perbedaan sumber sel, kondisi kultur, sistem bioreaktor, teknik isolasi, dan metode kontrol kualitas secara signifikan memengaruhi konsistensi dan aktivitas biologis sekretom. Teknologi bioproses tingkat lanjut yakni, termasuk sistem kultur 3D, media bebas serum, bioreaktor, dan produksi berbasis Good Manufacturing Practice (GMP)/Cara Pembuatan Obat yang Baik (CPOB), menunjukkan potensi untuk meningkatkan stabilitas dan reproduksibilitas produk. Protokol manufaktur yang terstandardisasi dan kontrol kualitas yang ketat sangat penting untuk mendukung translasi klinis masa depan dari terapi berbasis sekretom ini

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