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All Journal ANNALES BOGORIENSES Makara Journal of Science
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 Immunology & microbiology Medicine & Pharmacology

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 1 
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

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

Abstract

Co-Authors Adi Santoso Husnaa, Ulfatul Kusumawati, Arizah Neng Herawati, Neng RATIH ASMANA NINGRUM Wijaya, Sri Kartika Yana Rubiana, Yana