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All Journal HAYATI Journal of Biosciences Indonesian Journal of Cancer Chemoprevention ANNALES BOGORIENSES Health and Medical Journal Annales Bogorienses
RATIH ASMANA NINGRUM
Research Center for Biotechnology, Indonesian Institute of Sciences Jalan Raya Bogor km 46 Cibinong, West Java, Indonesia, 16911
Agriculture, Biological Sciences & Forestry Biochemistry, Genetics & Molecular Biology Chemical Engineering, Chemistry & Bioengineering Chemistry Earth & Planetary Sciences Health Professions Immunology & microbiology Medicine & Pharmacology Public Health

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The Emergence of Biosimilars in Indonesia: Guidelines, Challenges, and Prospects Wardiana, Andri; Ningrum, Ratih Asmana
Annales Bogorienses Vol. 20 No. 2 (2016): Annales Bogorienses
Publisher : BRIN

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According to the Food and Drug Administration (FDA), biosimilar is defined as a product which is highly similar to the reference product without clinically meaningful differences in safety, purity and potency. Indonesia is a developing country which has more than 250 million people. In 2008, the world market of biosimilar was USD 100 billions with 10-20% of domestic need from total market. Even though the need is very high, Indonesia still has not been able to produce Biosimilar independently. To stimulate the domestic production on biosimilar, National Agency for Drug and Food Control (NADFC) Republic of Indonesia has assigned Regulation of Biosimilar as Peraturan Kepala Badan Pengawas Obat Dan Makanan Republik Indonesia Nomor 17 Tahun 2015 Tentang Pedoman Penilaian Produk Biosimilar. The guidance covers the quality requirement and evaluation of Biosimilar products. Indonesian Ministry of Health has a strategic plan in biopharmaceutical covering biosimilar, which is going to be developed from 2015 to 2025. The strategy is expected to initiate biosimilar production in Indonesia. This review focuses on the guidelines of biosimilars in Indonesia compared to other international regulatory bodies, as well as the challenges and prospects of biosimilars development. 
Roferon-A: A Biologic Product of Human Interferon Alpha 2a Wardiana, Andri; Ningrum, Ratih Asmana
Annales Bogorienses Vol. 19 No. 2 (2015): Annales Bogorienses
Publisher : BRIN

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Human interferon alpha 2a (hIFNα2a) is a cytokine regulating immune system that has been used in hepatitis and cancer treatments. It has wide biological potency covering antiviral, antiproliferative and immunomodulative activities. This mini review discusses Roferon-A as a prominent commercial product of recombinant hIFNα2a which is produced in bacterial system, Escherichia coli, as therapeutic protein for several diseases, such as chronic viral Hepatitis B, Hepatitis C, melanoma, hairy cell leukemia and renal cell carcinoma. The discussion focuses on the development process with regard to its manufacturing, preclinical and clinical studies, as well as therapeutic efficacy. In addition, we also discuss biosimilar development of hIFNα2a and its potential future developments in the context of enhancing pharmacokinetic profiles.
Expression of No Affinity Tagged Recombinant Human Interferon Alpha-2a in Methylotrophic Yeast Pichia pastoris Herawati, Neng; Wardiana, Andri; Ningrum, Ratih Asmana
Annales Bogorienses Vol. 19 No. 2 (2015): Annales Bogorienses
Publisher : BRIN

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Recombinant human interferon alpha-2a (rhIFN-2a) has been widely used for clinical therapy as antiviral, anticancer as well as immunomodulator. In this study, the open reading frame (ORF) encoding synthetic hIFN-2a was constructed to be in framed with N-terminal alpha factor secretion system in methylotrophic yeast Pichia pastoris. This research aimed to construct, express and analyse the non-affinity tagged recombinant human interferon alpha-2a in the methylotrophic yeast P. pastoris. We used pPICZB plasmid for cloning and expression vector. The confirmed recombinant plasmid containing the correct DNA sequence of hIFN-2a was linearized by SacI restriction enzyme, then transformed into P. pastoris genome using electroporation. We screened two multi-copy recombinants in YPDS plates containing Zeocin™. Buffered complex medium containing 0.5 % methanol (BMMY) was used for protein expression for 48 hours in the culture condition. The recombinant protein was purified by blue sepharose affinity chromatography. Analyses of hIFN-2a protein by SDS-PAGE and Western blot confirmed that protein band in which was observed around 19.2 kDa, was recombinant hIFN-2a. The quantification of purified rhIFN-2a using colorimetric binichoninic assay (BCA) informed that the yield was 44 mg/L culture (OD600= 2-3). 
Co-Authors Adi Santoso Agustiyanti, Dian Fitria Ai Hertati, Ai Andri Wardiana, Andri Anky Zannati Apon Zaenal Mustopa Ario Betha Juanssilfero Azika, Wira Norman Azzahra, Salsabila Azzania Fibriani Budi Haryanto Desriani Desriani Ekawati, Nurlaili Endah Puji Septisetyani, Endah Puji Erdayani, Eva Ernawati A. Giri Rachman Ferry Iskandar Hariyatun, Hariyatun Herjuno Ari Nugroho, Herjuno Ari Himawan, Alayna Lillahida Indri Idris Idris Indriawati, Indriawati Irawan, Herman Jendri Mamangkey Joko Wahyono, Daniel Kartika Sari Dewi Komang Alit Paramitasari Kusdianawati Marissa Angelina Neng Herawati, Neng Novianti, Ela Nur Amani, Febriyanti Nurfatwa, Maritsa Permatasari, Fitri Aulia Popi Hadi Wisnuwardhani, Popi Hadi Prasetyaningrum, Pekik Wiji Putra, Andika Chandra Ramadani, Ratna Dwi Ridwanuloh, Asep Muhammad Saniyyah, Zahrah Setiawan, Ruby Setyawan, Ryan Haryo Siswahyudianto Sri Swasthikawati, Sri Stephanie, Rebecca Sushadi, Pangda Sopha Suyoko, Ahmad Taharuddin, Audrey Angelina Putri Utomo, Ahmad Rusdan Handoyo Vanggi, Leggina Rezzy wahyuni wahyuni Wahyuni, Ike Wahyuni, Ike Wardhani, Widdya Kusuma Wardhani, Widdya Kusuma Wijaya, Hans Wulandari, Ari Sulistyo Yamahoki, Nicholas Yana Rubiyana, Yana Yudi Purnomo Zaini, Jamal