Pengembangan Obat Biologi: Bioteknologi, Biosimilar, dan Reverse Engineering

Authors

Adi Santoso (ed)
Puslit Bioteknologi LIPI
DOI: https://doi.org/10.55981/brin.341

Keywords:

pengembangan obat biologi, biosimilar, reserve engineering

Synopsis

Obat-obatan merupakan salah satu aspek penting bagi masyarakat dalam pembangunan kesehatan. Namun, tidak semua masyarakat mumpuni untuk mencukupi kebutuhan tersebut karena tidak jarang harga yang dipasarkan tidak terjangkau. Masalah tersebut akan dapat dipecahkan apabila obat yang dibutuhkan tersedia dengan harga yang terjangkau oleh mereka yang membutuhkannya. Bioteknologi, Biosimilar, dan Reverse Engineering ini akan membahas cara-cara untuk mengembangkan obat biologi baru melalui biosimilar. Biosimilar merupakan salah satu cara pengembangan obat biologi dengan menggunakan aplikasi teknologi berbasis reverse engineering pada bioteknologi kesehatan. Buku ini merupakan kompilasi dari kegiatan yang telah dilakukan dengan riset mendalam dan dilengkapi dengan informasi-informasi penting. Lebih lanjut, buku ini juga menghadirkan refleksi terhadap kemajuan, peluang, dan tantangan biosimilar di masa yang akan datang. Tentunya, buku ini sangat cocok dibaca bagi para pemerhati industri obat dan pemangku kepentingan dibidang kesehatan

Chapters

  • Bioteknologi dan Biosimilar: Perkembangan Obat Berbasis Terapeutik Protein
    Adi Santoso
  • Regulasi Obat Biosimilar
    Eko Wahyu Putro , Gita Syahputra
  • Eritropoietin dan Obat Biosimilar: Sejarah Kesuksesan Terapi Anemia dan Tantangannya
    Adi Santoso, Yana Rubiyana, Arizah Kusumawati, Popi Hadi Wisnuwardhani, Endah Puji Septisetyani
  • Strategi Produksi Human Insulin Menggunakan Khamir Metilotropik Pichia pastoris
    Dini Nurdiani, Neng Herawati, WIEN KUSHARYOTO
  • Interferon Alfa-2a: Terapeutik Protein Untuk Penanganan Hepatitis dan Kanker
    Ratih Asmana Ningrum, Apon Zaenal Mustopa, Andri Wardiana
  • Tiga Dekade Human G-CSF dalam Dunia Medis: Perkembangan dan Manfaat
    Asrul Muhammad Fuad
  • Strategi Peningkatan Aktivitas Terapeutik Protein Melalui Modifikasi Protein
    Kartika Sari Dewi, Dian Fitria Agustiyanti
  • Formulasi Terapeutik Protein Rekombinan
    Riyona Desvy Pratiwi, Hariyatun, Ratih Asmana Ningrum
  • Bioproses Produk Obat Biosimilar
    Andri Wardiana, Ratih Asmana Ningrum, Eko Wahyu Putro
  • Refleksi Terhadap Kemajuan, Peluang dan Tantangan Biosimilar ke depan
    Adi Santoso, Puspita Lisdiyanti

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Author Biographies

Adi Santoso, Puslit Bioteknologi LIPI

Lahir di Jember, Jawa Timur, pada 17 Desember 1960. Ia menempuh pendidikan S1 di Fakultas Peternakan Universitas Brawijaya, Malang. Lulus dari Universitas Brawijaya pada tahun 1985, ia lalu diterima di LIPI pada 1986. Pada awal 1988, dengan menggunakan dana Overseas Fellowship Program (OFP), ia melanjutkan studi S2 ke Amerika Serikat dan belajar di North Dakota State University (NDSU), Fargo, North Dakota, pada bidang studi Animal Sciences. Setelah lulus S2, ia melanjutkan studi di Department of Biochemistry and Molecular Biology pada bidang studi Cellular and Molecular Biology di NDSU dengan disertasi tentang enzime ornithine decarboxylase pada Musca domestica. Ia kembali ke LIPI Puslit Bioteknologi pada 2003 dan saat ini minat risetnya terfokus pada glikosilasi dan biosimilar, terutama pada glikoprotein erythropoietin. E-mail: adi.santoso1960@gmail.com

Eko Wahyu Putro

Lahir di Pati pada 27 Mei 1981. Ia lulus Sarjana (S1) di Jurusan Teknik Kimia, Universitas Diponegoro, Semarang, tahun 2003. Ia lulus Magister (S2) di Jurusan Teknik Kimia, The University of New South Wales, Australia tahun 2013, mendapatkan beasiswa dari AusAID tahun 2012–2013. Saat ini, ia bekerja sebagai Peneliti Ahli Muda di Pusat Penelitian Bioteknologi LIPI dengan kepakaran Bioteknologi Kesehatan. E-mail: eko.wahyuputro@gmail.com

Adi Santoso

Lahir di Jember, Jawa Timur, pada 17 Desember 1960. Ia menempuh pendidikan S1 di Fakultas Peternakan Universitas Brawijaya, Malang. Lulus dari Universitas Brawijaya pada tahun 1985, ia lalu diterima di LIPI pada 1986. Pada awal 1988, dengan menggunakan dana Overseas Fellowship Program (OFP), ia melanjutkan studi S2 ke Amerika Serikat dan belajar di North Dakota State University (NDSU), Fargo, North Dakota, pada bidang studi Animal Sciences. Setelah lulus S2, ia melanjutkan studi di Department of Biochemistry and Molecular Biology pada bidang studi Cellular and Molecular Biology di NDSU dengan disertasi tentang enzime ornithine decarboxylase pada Musca domestica. Ia kembali ke LIPI Puslit Bioteknologi pada 2003 dan saat ini minat risetnya terfokus pada glikosilasi dan biosimilar, terutama pada glikoprotein erythropoietin. E-mail: adi.santoso1960@gmail.com

Dini Nurdiani

Lahir di Kuningan pada tanggal 17 Juli 1974. Ia lulus S1 program studi Biologi dari Institut Pertanian Bogor (IPB) pada 1997 dan menjadi staf pengajar di Universitas Kuningan pada 2000–2007. Pada 2006, ia lulus S2 Program Studi Biologi, Sub-Program Mikrobiologi IPB dengan beasiswa Program Pascasarjana (BPPS) dari Direktorat Jenderal Pendidikan Tinggi (Dikti). Pada 2007, ia bergabung dengan Pusat Penelitian Bioteknologi LIPI, kemudian melanjutkan studi S3 dengan beasiswa Global Center of Excellence (global COE) for Practical Chemical Wisdom (2009–2012) di Department of Life Science and Medical Bioscience, Waseda University, Tokyo, Jepang, dengan bidang keahlian rekayasa biologi molekuler, dan lulus pada 2015. Saat ini, ia tergabung dalam Kelompok Penelitian Produk Biologi di Pusat Penelitian Bioteknologi LIPI. E-mail: dini011@lipi.go.id.

Ratih Asmana Ningrum, Pusat Penelitian Bioteknologi LIPI

Lahir di Bandung pada 18 Juni 1979. Ia lulus Diploma III (D-3) di bidang Kimia Analisis Universitas Padjadjaran Bandung tahun 2000 dan Sarjana (S1) di bidang Kimia, Universitas Ahmad Yani, Bandung, tahun 2004. Ia melanjutkan magister (S2) dan doktor (S3) di bidang Bioteknologi Farmasi, Institut Teknologi Bandung (ITB), masing-masing pada tahun 2008 dan 2012, dengan beasiswa dari ITB. Saat ini, ia bekerja sebagai Peneliti Ahli Madya dan Ketua Kelompok Penelitian Pengembangan Produk Biologi di Pusat Penelitian Bioteknologi LIPI dengan kepakaran Bioteknologi Kesehatan. Selain itu, ia bertugas sebagai Kepala Fasilitas Biosafety Level-3 LIPI pada tahun 2018-2020 dan Ketua Komite Biorisiko Institusional di LIPI sejak tahun 2021.. Ia mendapatkan penghargaan The UNESCO-Loreal for Women in Sciences pada tahun 2013 untuk kategori Life Science. E-mail: rati004@lipi.go.id/ ratih.asmana@gmail.com

Asrul Muhammad Fuad, Pusat Penelitian Bioteknologi LIPI

Lahir di Jakarta pada 26 Juli 1967. Ia mendapat beasiswa Overseas Fellowship Program (OFP) pada 1987 dan memperoleh Diplome d’Etude de Technologie de Compiegne pada 1991 dari Universite de Technologie de Compiegne, di Kota Compiegne, Prancis. Ia mendapatkan gelar Sarjana Kimia pada 1996 di Universitas Pakuan, Bogor. Kemudian, ia melanjutkan pendidikan Pascasarjana di School of Biotechnology and Bioengineering di University of New South Wales, Australia, dan Fakultas Pascasarjana di Institut Teknologi Bandung pada 1998–2000 dan mendapat gelar Magister of Science dalam bidang Bioteknologi (Dual Diplome) dengan beasiswa dari Kementerian Riset dan Teknologi RI. Pada 2004, ia melanjutkan pendidikan doktorat (S3) di Sekolah Farmasi, Institut Teknologi Bandung, dan memperoleh gelar Doktor dalam bidang Bioteknologi Farmasi pada 2009 dengan beasiswa dari Lembaga Ilmu Pengetahuan Indonesia.

Kartika Sari Dewi, Pusat Penelitian Bioteknologi LIPI

Lahir di Bandung pada 22 Januari 1989. Ia lulus Sarjana (S1) di bidang Kimia Organik, Universitas Padjadjaran pada 2010. Ia mulai bekerja di Pusat Penelitian Bioteknologi LIPI pada 2011 dan mendapatkan beasiswa Karyasiswa Ristek pada 2012–2014 untuk melanjutkan pendidikan Magister (S2) pada program studi Bioteknologi Farmasi, Institut Teknologi Bandung. Saat ini, ia tergabung pada Kelompok Penelitian Pengembangan Produk Biologi sebagai Peneliti Ahli Muda dengan bidang kepakaran Bioteknologi Kesehatan. Ia juga bekerja akrab dengan desain gen sintetik, kloning, dan ekspresi protein rekombinan yang diproduksi secara heterolog. E-mail: kart008@lipi.go.id; kasadewi@gmail.com.

Riyona Desvy Pratiwi, Pusat Penelitian Bioteknologi LIPI

arjana (S1) di bidang Farmasi Sains dan Industri, Universitas Gadjah Mada, Yogyakarta, tahun 2008, kemudian melanjutkan Pendidikan Profesi Apoteker Konsentrasi Industri, lulus pada 2009. Ia pernah bekerja sebagai Formulator di Departemen Pengembangan Produk PT. Novell Pharmaceutical Labs, Bogor. Ia lulus magister (S2) di bidang Inovasi Obat pada 2016, dengan topik penelitian high throughput/high consent screening untuk senyawa antikanker di Department of Cell Biology, Universiteit Medical Utrecht, dan nanoformulasi protein di Department of Pharmaceutics, Utrecht Institute of Pharmaceutics Sciences, Universiteit Utrecht. Ia mendapatkan beasiswa dari Lembaga Pengelola Dana Pendidikan (LPDP), Kementerian Keuangan Republik Indonesia. Saat ini ia bekerja sebagai Peneliti Ahli Muda di Pusat Penelitian Bioteknologi LIPI dengan kepakaran Bioteknologi Kesehatan. E-mail: riyo003@lipi.go.id.

Andri Wardiana, Pusat Penelitian Bioteknologi LIPI

Lahir di Bandung pada 15 Oktober 1983. Ia menyelesaikan Pendidikan D3 Analis Kimia di Universitas Padjadjaran Bandung (2001–2004). Pada 2006, ia bergabung dengan Pusat Penelitian Bioteknologi LIPI. Jenjang pendidikan Sarjana Kimia ia ditempuh di Institut Pertanian Bogor (2007–2010), lalu mendapatkan beasiswa dari Australia Award untuk menyelesaikan program Master di bidang Bioteknologi di the University of Queensland, Australia (2013–2014). Pada 2015, ia mendapatkan beasiswa LPDP untuk program Doktor dengan topik rekayasa antibodi di Centre for Biopharmaceutical Innovation, Australian Institute for Bioengineering and Nanotechnology, the University of Queensland, Australia (2016–2020). Saat ini, ia tergabung dalam Kelompok Penelitian Produk Biologi di Pusat Penelitian Bioteknologi LIPI. E-mail: andr011@lipi.go.id

Yana Rubiyana, Pusat Penelitian Bioteknologi

Lahir di Bogor, Jawa Barat, pada 21 Februari 1984. Ia lulus pendidikan Diploma III jurusan Analis Kimia, di Fakultas Matematika dan Ilmu Pengetahuan Alam (FMIPA), Institut Pertanian Bogor (IPB) pada 2002, lalu pada 2009 ia melanjutkan pendidikan Sarjana (S1) melalui Program Alih Jenjang di Departemen Kimia FMIPA IPB. Pada pertengahan 2017, ia mendapatkan beasiswa SDM-IPTEK (Saintek) Kementerian Riset, Teknologi, dan Pendidikan Tinggi untuk melanjutkan studi S2 pada Program Studi Bioteknologi IPB. Sejak tahun 2008 sampai saat ini ia bekerja sebagai Perekayasa Ahli Pertama di Pusat Penelitian Bioteknologi LIPI dengan kepakaran Bioteknologi dan Biologi Molekuler. E-mail: yana.rubiyana@biotenologi.lipi.go.id.

Gita Syahputra, usat Penelitian Bioteknologi LIPI

Ia adalah Peneliti di Pusat Penelitian Bioteknologi LIPI sejak 2015 hingga sekarang dengan kepakaran Bioteknologi Kesehatan dengan fokus pada bi­dang Biokimia dan Aplikasi Bioinformatika. Ia lulus Sarjana (S1) di bidang Kimia, Universitas Diponegoro, Semarang, tahun 2012. Ia melanjutkan studi Magister (S2) bidang Biokimia di Institut Pertanian Bogor (IPB) dan lulus tahun 2014. Saat ini, ia tengah melakukan penelitian mengenai penemuan dan pengembangan obat dari bahan alam serta melakukan penelitian dalam permodelan protein, penambatan molekuler, dan dinamika molekul obat. Beberapa jurnal yang dihasilkan bisa diakses pada https://www.researchgate.net/profile/Gita_Syahputra2 serta https://scholar.google.com/citations?user=aif-rbYAAAAJ&hl=en.

Arizah Kusumawati, Pusat Penelitian Bioteknologi LIPI

Lahir di Boyolali pada 11 Oktober 1984. Ia lulus Sarjana (S1) Kedokteran Hewan Universitas Gadjah Mada (UGM) tahun 2006 dan melanjutkan studi Profesi Dokter Hewan di Fakultas Kedokteran Hewan UGM, lulus tahun 2007. Ia kemudian meneruskan studi Magister (S2) Farmasi bidang Biologi Farmasi, Universitas Indonesia (UI), lulus tahun 2013, mendapatkan beasiswa dari Kementerian Riset dan Teknologi (KEMENRISTEK). Saat ini ia sedang melanjutkan studi Doktor (S3) Kesehatan Masyarakat Veteriner di Fakultas Kedokteran Hewan, Institut Pertanian Bogor (IPB), mendapatkan beasiswa program byResearch dari Lembaga Ilmu Pengetahuan Indonesia (LIPI). Saat ini ia pun bekerja sebagai Peneliti Ahli Muda di Pusat Penelitian Bioteknologi LIPI dengan kepakaran Bioteknologi Kesehatan. E-mail: arizahku@gmail.com

Popi Hadi Wisnuwardhani, Pusat Penelitian Bioteknologi LIPI

Kelahiran Bogor 19 Oktober 1981. Ia bekerja di Pusat Penelitian Bioteknologi LIPI sejak tahun 2011. Pendidikan terakhir pada Magister (S2) Program Studi Biologi, Universitas Jenderal Soedirman, Purwokerto. Ia bekerja sebagai Peneliti Ahli Muda dengan kepakaran Bioteknologi Kesehatan di Laboratorium Protein Terapeutik dan Vaksin. Penelitian yang dilakukan selama bekerja adalah ekspresi dan purifikasi protein rekombinan serta kultur sel mamalia. Selain itu, ia bergabung sebagai pengelola fasilitas Laboratorium Biosafety Level-3 LIPI sejak tahun 2018. Pada 2019, ia mengikuti kegiatan penelitian pengembangan produk biologi, dan pada awal 2020 ia aktif sebagai BioSafety Officer pada kegiatan deteksi virus SARS-CoV-2 COVID-19 sampai sekarang. E-mail: popi002@lipi.go.id.

Endah Puji Septisetyani, Pusat Penelitian Bioteknologi LIPI

Lahir di Rembang, Jawa Tengah, pada 27 September 1984. Dibesarkan dalam keluarga guru yang sederhana, ia mendapatkan beasiswa dari Yayasan Syifa Budi (Bapak Maulwi Saelan) untuk bersekolah di SMU Al-Azhar Boarding School, Lippo Cikarang, Bekasi (1999–2001). Ia menyelesaikan studi S1–S2 di Fakultas Farmasi, Universitas Gadjah Mada (UGM) (2001–2005; 2007–2009) dan bergabung dengan Cancer Research Group bimbingan Prof. Dr. Edy Meiyanto. Pada saat menempuh S2, ia mendapatkan on-place scholarship dari ASEA-Uninet, Austria. Pada tahun kedua studi, ia menjalani Program Research Student (JASSO scholarship) di Laboratory of Gene Function in Animal, Nara Institute of Science and Technology (NAIST), Jepang, di bawah bimbingan Prof. Masashi Kawaichi (2008–2009). Ia mulai bekerja di Pusat Penelitian Bioteknologi LIPI pada 2009, di Laboratorium Protein Terapetik dan Vaksin bimbingan Dr. Adi Santoso, dan memulai pekerjaan kultur sel mamalia untuk ekspresi protein rekombinan erythropoietin. Ia melanjutkan studi S3 di NAIST, Jepang dengan beasiswa dari Ministry of Education, Culture, Sports, Science and Technology, Pemerintah Jepang dan bergabung di Laboratory of Molecular Signal Transduction di bawah bimbingan Prof. Hiroshi Itoh (2014–2018). Saat ini, ia kembali bergabung dengan tim peneliti biosimilar erythropoietin. Selain itu, ia ingin menginisiasi pengembangan antibodi monoklonal serta penelitian-penelitian berbasis target molekuler (molecular targeted therapeutics). E-mail: enda053@lipi.go.id

Neng Herawati, Pusat Penelitian Bioteknologi LIPI

Lahir di Pekanbaru pada 6 Agustus 1978. Sarjana S1 diselesaikannya pada 2003 di Fakultas FMIPA jurusan kimia Universitas Riau (UNRI). Ia lulus Magister (S2) di bidang Bioteknologi, Institut Pertanian Bogor, tahun 2013, dan mendapatkan beasiswa dari Kemenristek Republik Indonesia tahun 2010–2013. Saat ini, ia be­kerja sebagai Peneliti Ahli Muda di Pusat Penelitian Bioteknologi LIPI dengan kepakaran Bioteknologi Kesehatan. E-mail: neng07@gmail.com

WIEN KUSHARYOTO, Pusat Penelitian Bioteknologi LIPI

Lahir di Yogyakarta pada 7 Januari 1967. Ia menye­lesaikan Pendidikan Kimia dengan fokus pada bidang Biokimia dan Bioteknologi serta mendapatkan gelar Diplom-Chemiker dari Technische Universität Braunschweig, Jerman pada 1994 dengan beasiswa Overseas Fellowship Program (OFP) tahun 1987–1994 dari Pemerintah Indonesia. Ia lulus program Doktor (S3) di bidang Biokimia dan Bioteknologi dari Universität Stuttgart tahun 2001 dengan beasiswa dari Pemerintah Jerman melalui DAAD tahun 1997–2001. Saat ini bekerja sebagai Peneliti Ahli Madya di Pusat Penelitian Bioteknologi LIPI dengan bidang kepakaran Bioteknologi (Rekayasa Genetika dan Protein). E-mail: wien.kyoto@gmail.com

Apon Zaenal Mustopa, Pusat Penelitian Bioteknologi LIPI

Lahir di Kuningan pada 12 April 1977. Ia lulus Sarjana (S1) di bidang peternakan, Universitas Padjadjaran (UNPAD), tahun 2001. Ia melanjutkan studi Magister (S2) bidang Bioteknologi, Institut Pertanian Bogor (IPB), lulus tahun 2004. Ia juga mendapatkan beasiswa dari Dankook University, Korea, dan lulus Doktor (S3) bidang Bioresources Science tahun 2013. Saat ini, ia bekerja sebagai Peneliti Ahli Madya di Pusat Penelitian Bioteknologi LIPI dengan kepakaran Bioteknologi Kesehatan. E-mail: azmustopa@yahoo.com

Dian Fitria Agustiyanti, Pusat Penelitian Bioteknologi LIPI

erempuan kelahiran Kota Bandung pada 7 Agustus 1980 ini memulai karir di LIPI pada 2005. Pendidikan terakhirnya adalah magister (S2) farmasi Institut Teknologi Bandung, jurusan bioteknologi farmasi. Ia bergabung dengan Laboratorium Rekayasa Protein dan Pengembangan Sistem Pengantaran Obat Pada Pusat Penelitian Bioteknologi LIPI. Ia bekerja akrab dengan ekspresi dan purifikasi protein rekombinan, sebagai peneliti ahli muda dengan bidang kepakaran bioteknologi kesehatan. Mulai tahun 2019, ia mengelola fasilitas Laboratorium Biosafety level 3 (BSL-3) LIPI, dan Kelompok Penelitian Pengembangan Produk Biologi. Di era pandemic COVID 19, ia ikut bekerja sama dan berperan aktif dalam tim deteksi virus SARS-CoV-2 di Laboratorium BSL 3 LIPI. E-mail: dian.fitria07@gmail.com; dian010@lipi.go.id

Hariyatun, Pusat Penelitian Bioteknologi LIPI

Lahir di Klaten pada 30 Agustus 1982. Ia lulus Sarjana (S1) di bidang Kimia Fisika, Universitas Gadjah Mada, Yogyakarta, tahun 2005, mendapatkan Beasiswa Bank Indonesia (BI). Lulus Magister (S2) di bidang Bioteknologi Kesehatan, Institut Pertanian Bogor, tahun 2014, mendapatkan Beasiswa Pascasarjana dari Kementerian Riset dan Teknologi Republik Indonesia dan Beasiswa Tesis dari Lembaga Pengelola Dana Pendidikan (LPDP), Kementerian Keuangan Republik Indonesia. Saat ini ia bekerja sebagai Peneliti Ahli Muda di Pusat Penelitian Bioteknologi LIPI dengan kepakaran Bioteknologi Kesehatan pada Laboratorium Rekayasa Genetika Terapan dan Desain Protein dan Kelompok Penelitian Pengembangan Produk Biologi Kesehatan, serta bergabung dalam Tim Deteksi Virus SARS-CoV-2 di Laboratorium Biosafety Level-3 (BSL-3) LIPI. E-mail: hari023@lipi.go.id

Puspita Lisdiyanti, Pusat Penelitian Bioteknologi LIPI

Lahir di Yogyakarta pada 14 Agustus 1967. Ia lulus Sarjana (S1) di bidang Biologi Molekular, Tokyo University of Agriculture and Technology, Jepang, tahun 1992 dengan beasiswa Overseas Fellowship Program (OFP) tahun 1987–1992 dari Pemerintah Indonesia. Kemudian, ia lulus Magister (S2) di bidang Mikrobiologi, Tokyo University of Agriculture, Jepang, tahun 1999 dengan beasiswa dari Indonesia Petroleum (INPEX) Foundation tahun 1996–1999. Selan­jutnya ia melanjutkan studi Doktor (S3) di bidang Mikrobiologi dari Tokyo University of Agriculture, Jepang, tahun 2001 dengan beasiswa dari Pemerintah Jepang (Monbukagakusho) tahun 1999–2001. Ia pun tercatat sebagai penerima penghargaan Habibie Prize tahun 2020. Saat ini, ia bekerja sebagai Peneliti Ahli Utama di Pusat Penelitian Bioteknologi LIPI dengan kepakaran Mikrobiologi dan Bioteknologi. E-mail: puspita.lisdiyanti@bioteknologi.lipi.go.id

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