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All Journal HAYATI Journal of Biosciences ANNALES BOGORIENSES Narra J Makara Journal of Science Annales Bogorienses
Andri Wardiana, Andri
Research Center for Biotechnology, Indonesian Institute of Sciences Jl. Raya Bogor KM 46, Cibinong, Bogor, 16911, Indonesia
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 : Research Center for Biotechnology - Indonesian Institute of Sciences (LIPI)

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.14203/ab.v20i2.272

Abstract

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. The domestic need of Biosmilar in Indonesia is about 10-20%.  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. The Ministry of Health of Indonesia has a strategic plan in biopharmaceutical covering biosimilar which is going to develop in 2015-2025. The strategy is expected to initiate biosimilar production in Indonesia. This review focuses on the guidelines, challenges and prospects biosimilars in Indonesia comparing to other international regulatory bodies.Keywords: Biosimilar, Indonesia, Guidelines, Challenges and Prospects
In-Silico Cloning and Analysis of Divalent Subunit OMP31-SODc Proteins As A Prophylaxis Vaccine Against Brucella melitensis Infection Wijaya, Sri Kartika; Kusumawati, Arizah; Wardiana, Andri; Rubiana, Yana; Husnaa, Ulfatul; Santoso, Adi
ANNALES BOGORIENSES Vol 19, No 1 (2015): Annales Bogorienses
Publisher : Research Center for Biotechnology - Indonesian Institute of Sciences (LIPI)

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (965.993 KB) | DOI: 10.14203/ab.v19i1.94

Abstract

The urgency to develop a new protein based subunit vaccine candidate against Brucella was provoked by its frequent infection to human and lives stock. Since Brucella melitensis is found as the most species isolated from human, thus the outer membrane of the Brucella melitensis become prominent subcellular location for searching promising antigen to be developed as vaccine target due to its interaction with cell host. Among other proteins suggested by Vaxign program, the OMP31 is found as a promising candidate. Moreover, analysis on other subcellular location leads our interest to SODc protein, which is expected to support the OMP31 in triggering immune response. The OMP31-SODc divalent vaccine candidate was analysed in-silico to predict its stable three-dimensional structure, cloning process and expectation on the ease during expression, purification and the protein vaccine delivery to develop expected immune response.
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 : Research Center for Biotechnology - Indonesian Institute of Sciences (LIPI)

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (423.11 KB) | DOI: 10.14203/ab.v19i2.86

Abstract

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 Methilotropic Yeast Pichia pastoris Herawati, Neng; Wardiana, Andri; Ningrum, Ratih Asmana
ANNALES BOGORIENSES Vol 19, No 2 (2015): Annales Bogorienses
Publisher : Research Center for Biotechnology - Indonesian Institute of Sciences (LIPI)

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.14203/ab.v19i2.254

Abstract

Recombinant human interferon alpha-2a (rhIFNα-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 hIFNα-2a was constructed to be in framed with N-terminal alpha factor secretion system in methylotropic yeast Pichia pastoris. This research aimed to construct, express and analyse the non-affinity tagged recombinant human interferon alpha-2a in the methilotropic yeast P. pastoris. We used pPICZαB plasmid for cloning and expression vector. The confirmed recombinant plasmid containing the correct DNA sequence of hIFNα-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 hIFNα-2a protein by SDS-PAGE and Western blot confirmed that protein band in which was observed around 19.2 kDa, was recombinant hIFNα-2a. The quantification of purified rhIFNα-2a using colorimetric binichoninic assay (BCA) informed that the yield was 44 mg/L culture (OD600= 2-3).
PURIFICATION AND CARBOHYDRATE ANALYSIS OF RECOMBINANT HUMAN ERYTHROPOIETIN EXPRESSED IN YEAST SYSTEM Pichia pastoris Wardiana, Andri; Santoso, Adi
Makara Journal of Science Vol. 15, No. 1
Publisher : UI Scholars Hub

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Abstract

SARS-CoV-2 lineages and naso-oropharyngeal bacterial communities in COVID-19 reinfection: A study in West Java, Indonesia Sativa, Alvira R.; Asyifa, Isnaini Z.; Adzdzakiy, Muhammad M.; Iryanto, Syam B.; Nugroho, Herjuno A.; Wulandari, Ari S.; Yanthi, Nova D.; Nasrulloh, Mukh F.; Rahmawati, Ema; Alamanda, Cut NC.; Ristandi, Ryan B.; Rachman, Rifky W.; Robiani, Rini; Agustiyani, Dian F.; Wisnuwardhani, Popi H.; Wardiana, Andri; Ningrum, Ratih A.; Dharmayanthi, Anik B.; Prasetyoputri, Anggia; Fibriani, Azzania; Saputra, Sugiyono
Narra J Vol. 5 No. 3 (2025): December 2025
Publisher : Narra Sains Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.52225/narra.v5i3.2901

Abstract

Continuous emergence of new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants may influence viral transmission dynamics and alter interactions with the respiratory microbiota, potentially increasing the risks of reinfection. This study investigated cases of coronavirus disease 2019 (COVID-19) reinfection in West Java, Indonesia, with the aim of identifying the SARS-CoV-2 variants involved, characterizing their genomic mutations, and profiling the nasal and oropharyngeal microbiota associated with reinfection. Naso-oropharyngeal swab samples were collected from 42 COVID-19 reinfection cases and nine new infection cases. Whole genome sequencing was performed using Oxford Nanopore Technologies (ONT) MinION Mk1C and variant analysis was conducted using ARTIC workflow. Nexstrain and PANGOLIN were used to determine the lineages. Phylogenetic trees were constructed using IQ-tree and FigTree. Key mutations were identified by Cov-GLUE. Additionally, 16s rRNA amplicon sequencing was conducted on nine samples from each group to analyze bacterial communities using EPI2ME and MicrobiomeAnalyst. All identified SARS-CoV-2 strains in this study were Delta variant (B.1.617.2), predominantly lineage AY.23 (n=46, 90%), followed by AY.24 (n=3) and AY.109 (n=2). No differences in SARS-CoV-2 lineages were observed between reinfection and new infection cases. Unique hotspot mutations found only in COVID-19 reinfections included NSP3, V220A, S_T676I, ORF7a_V82A, and ORF7a_TI20I. Bacterial community analysis revealed no significant diversity differences (alpha and beta) between the two groups. While the most dominant phylum remained Terrabacteria in both groups, Streptococcus was dominant in COVID-19 reinfections, whereas Prevotella was dominant in new infection cases. Notably, Haemophilus parainfluenzae, Fusobacterium periodonticum, Fusobacterium nucleatum, and Leptotrichia buccalis had significant increases in reinfection cases. Despite the similarity in SARS-CoV-2 lineages causing both COVID-19 reinfection and new infection cases, the presence of distinct key mutations and bacterial species suggest their potential as biomarkers within this group.
Evaluation of Curcumin-derived Carbon-dots' Inhibitory Activity as SARS-CoV-2 Antiviral Candidate Using Chemical Crosslinking Taharuddin, Audrey Angelina Putri; Yamahoki, Nicholas; Stephanie, Rebecca; Agustiyanti, Dian Fitria; Wisnuwardhani, Popi Hadi; Angelina, Marissa; Rubiyana, Yana; Ningrum, Ratih Asmana; Wardiana, Andri; Desriani, Desriani; Hariyatun, Hariyatun; Iskandar, Ferry; Permatasari, Fitri Aulia; Giri-Rachman, Ernawati Arifin; Fibriani, Azzania
HAYATI Journal of Biosciences Vol. 33 No. 1 (2026): January 2026
Publisher : Bogor Agricultural University, Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.4308/hjb.33.1.232-239

Abstract

In our previous work, we demonstrated that curcumin-derived carbon dots (Cur-CDs) have potential as antivirals for COVID-19. However, the precise mechanism of action remains unclear. This study investigated the potential of Cur-CDs against SARS-CoV-2 by targeting the dimerization of the C-terminal domain of nucleocapsid protein (N-CTD) using chemical crosslinking. Recombinant SARS-CoV-2 N-CTD was expressed, purified, and subjected to chemical crosslinking. The dimerization inhibition ability of Cur-CDs was assessed with ligand concentrations ranging from 0 to 2,000 μg/mL. Successful inhibition —defined as a noticeable reduction in SARS-CoV-2 N-CTD dimer band intensity on SDS-PAGE—was observed when Cur-CDs were present at 8 to 16 times the protein concentration. We hypothesize that Cur-CDs bind to the dimerization residues, preventing non-covalent interactions between monomers and limiting dimer formation. Our findings suggest that Cur-CDs could be a promising antiviral strategy for SARS-CoV-2, especially targeting the dimerization of the nucleocapsid protein. Additionally, this study also highlights the use of chemical crosslinking as a valuable tool for interaction-based drug screening.
Mini Review: Prostate Cancer Diagnosis and Therapy Fathurahman, Alfi Taufik; Swasthikawati, Sri; Irawan, Herman; Supriatna, Dadang; Wardiana, Andri
Annales Bogorienses Vol. 25 No. 2 (2021): Annales Bogorienses
Publisher : BRIN

Show Abstract | Download Original | Original Source | Check in Google Scholar

Abstract

Cancer, a non-communicable illness, is the leading cause of death worldwide. In 2030, cancer is expected to exceed 21 million cases and 13 million cancer deaths globally. One of the most prevalent and significant types is prostate cancer (PCa). It is commonly associated with adenocarcinoma, which develops from the mucous glands within the organ. This review highlights available detection systems, and therapeutic options in PCa management. One prevention of deadly PCa is early diagnoses, such as prostate-specific antigen (PSA) screening or genomic profiling. Further testing like MRI or CT scan may also be needed to detect cancers that have progressed to other body regions. There are several possible treatments for PCa, including watchful cancer waiting, surgery, radiotherapy, hormone therapy, and chemotherapy. Based on current studies, androgen deprivation therapy (ADT) combined with docetaxel therapy enhanced great results to treat advanced PCa. The latest development, called theranostics, is a single entity that can perform both diagnostic and therapeutic functions. It can detect disease borders, track therapy in real-time, and provide prognostic data. The FDA has already authorized two prostate-specific membrane antigen (PSMA) positron emission tomography (PET) devices: including Gallium 68 PSMA-11 (Ga 68 PSMA-11) and Pylarify (piflufolastat F 18).
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

Show Abstract | Download Original | Original Source | Check in Google Scholar

Abstract

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. 
In-Silico Cloning and Analysis of Divalent Subunit OMP31-SODc Proteins As A Prophylaxis Vaccine Against Brucella melitensis Infection Wijaya, Sri Kartika; Kusumawati, Arizah; Wardiana, Andri; Rubiyana, Yana; Husnaa, Ulfatul; Santoso, Adi
Annales Bogorienses Vol. 19 No. 1 (2015): Annales Bogorienses
Publisher : BRIN

Show Abstract | Download Original | Original Source | Check in Google Scholar

Abstract

The urgency to develop a new protein subunit based vaccine candidate against Brucella was provoked by its frequent infection to human and livestock. Since Brucella melitensis is found as the most frequently isolated Brucella species from human, thus the outer membrane of B. melitensis becomes a prominent subcellular localization to search for promising antigen to be developed as vaccine candidate due to its interaction with host cell. Among outer membrane proteins suggested by Vaxign program, OMP31 was found as the most promising candidate. Moreover, analysis on other subcellular localization led our interest to SODc protein, which was expected to support OMP31 in triggering immune response. The OMP31-SODc divalent vaccine candidate was analysed in silico to predict its stable three-dimensional structure, cloning process and expectation on the ease during expression, purification and vaccine delivery to elicit the expected immune response.
Co-Authors Adi Santoso Adzdzakiy, Muhammad M. Agustiyani, Dian F. Agustiyanti, Dian Fitria Alamanda, Cut NC. Asyifa, Isnaini Z. Dadang Supriatna Damai, Fedric Intan Desriani Desriani Dharmayanthi, Anik B. Ema Rahmawati ERNAWATI ARIFIN GIRI-RACHMAN Fathurahman, Alfi Taufik Fathurahman, Alfi Taufiq Ferry Iskandar Fibriani, Azzania Hariyatun, Hariyatun Husnaa, Ulfatul Husnaa, Ulfatul Irawan, Herman Iryanto, Syam B. Kusumawati, Arizah Kusumawati, Arizah Marissa Angelina Nasrulloh, Mukh F. Neng Herawati, Neng Ningrum, Ratih A. Nugroho, Herjuno A. Permatasari, Fitri Aulia Popi Hadi Wisnuwardhani, Popi Hadi Prasetyoputri, Anggia Purwanto, Gracia Christine Lembong Rachman, Rifky W. RATIH ASMANA NINGRUM Ristandi, Ryan B. Robiani, Rini Saputra, Sugiyono Sativa, Alvira R. Sri Swasthikawati, Sri Stephanie, Rebecca Taharuddin, Audrey Angelina Putri Wijaya, Sri Kartika Wijaya, Sri Kartika Wisnuwardhani, Popi H. Wulandari, Ari S. Yamahoki, Nicholas Yana Rubiana, Yana Yana Rubiyana, Yana Yanthi, Nova D.