i3L Pharmacy Students Visited PT Kalbio Global Medika
Indonesia International Institute for Life Sciences (i3L) is a premium life sciences higher education and research institute located in Jakarta, Indonesia. i3L has a vision to be a leading and globally-connected interdisciplinary institution that impacts society through science and innovation. i3L offers undergraduate programs and graduate program. Undergraduate programs in i3L includes Bioinformatics, Biomedicine, Biotechnology, Food Science and Nutrition, Food Technology, Pharmacy, Business and Entrepreneurship in Life Sciences, International Business Management in Creative Digital Marketing, International Business Management in International Applied Accounting, International Business Management, etc. Graduate programs in i3L includes Master in Biomanagement.
Pharmacy is one of majors focuses on medicine, which covers from drug discovery, development, clinical trial, drug delivery, drug management and also patient counseling. Pharmacy is the bridge knowledge between biomedical scientists and medical doctors, and highly relates to biomedical science, chemistry, pharmacology, pharmaceutical engineering, social science and population health.
On 29 Sep 2022, students of Faculty of Phamacy accompanied by Dr. Khoe Ulung Gondo Kusumo, S.Si., M.Sc. carried out industrial visit to PT Kalbio Global Medika (KGM). This visit is aimed to get insights and industrial applications of pharmacy and biopharmaceuticals knowledges. Their visit was started with opening speech from Mr. Nakkiran Saravanakumar, KGM Director followed by explanation about KGM Company Profile.
They were divided into two groups for plant tour to Production area and QC area. In Production area, they were explained and shown from upstream processes up to downstream processes to produce Drug Substances. Upstream process involves automatic cell culture handling using robotic arm to maintain consistency, accuracy, and repeatability, and to increase sterility assurance.
They were also explained and shown the buffer media preparation processes and filling-and-finish processes. Filling-and-finish processes involve isolator for filing process and automatic inspection machine. We are the first biopharmaceutical manufacturer equipped with isolator for filling process. The products are 100% inspected using automatic inspection machine before going to packaging process.
After plant tour to production area, they were brought to QC area. They were explained regarding QC testing to ensure that the products meet all the requisite standards. The testing are performed by highly skilled, qualified, and experienced scientists. The tests are conducted in our laboratory facilities, such as microbiology, psycho-chemistry, and/or biochemistry laboratory, which had been certified complied to the EU GMP based on the audit undertook by PCI Pharma Services.
They were also explained regarding the stability study, retain samples, and cell bank storage. Stability samples are also collected, stored, and frequently tested for stability study.
KGM at a Glance
Kalbio Global Medika (KGM) is one of the first and the pioneer of biopharmaceuticals in Indonesia, established in 2014 and inaugurated officially in 2018 by the President of the Republic of Indonesia, Ir. Joko Widodo. KGM is part of the Kalbe Group, a subsidiary of PT Kalbe Genexine Biologics (KGbio), which is a clinical-stage biotechnology company focused on bringing biologics medical innovation to markets outside US/Canada, Western Europe, and China. KGM is an Innovative CDMO, equipped with CMC and scale-up capabilities plugged into Boston biotech ecosystem and state-of-the-art facility to enhance efficiency and productivity. With API manufacturing, formulation, fill and finish capabilities of biosimilar and novel biologics, averaging 10 million units of syringes, cartridges, and vials, KGM supplies local and international markets.