Monitoring of Biologics Product Development by MOH of Indonesia at PT Kalbio Global Medika
On 28 Jul 2022, PT Kalbio Global Medika was visited by Directorate of Pharmaceutical and Medical Devices, Ministry of Health (MOH) of Indonesia. The government through this directorate is currently develop and compose biologics drug products industrial trees to support the resistance of pharmaceutical and medical devices in Indonesia. The objective of the visit was to do monitoring of biologics drug products development performed by PT Kalbio Global Medika. The representatives from MOH are Refiandes, S.Si., Apt., MPH, Associate health administrator, Pensa Resta Grahmidri, S.Farm., Apt., MKM, Policy analyst and policy makers, Setyanti Indah Lestari, S.Farm., Apt., MKM, Young expert health administrator, Mayangsari, S.Farm., Apt., First expert health administrator, Ahmad Hariri, Apt., Health administrator, Letare Merry Chresia Silalahi, and apt. Septrina Wulandari, S.Farm.
During the visit, they did facility tour to API manufacturing area, Formulation-Fill-Finish manufacturing area QC area, stability chamber, and cell bank area. We had various discussions regarding manufacturing flow process of biologics drugs produced in PT Kalbio Global Medika.
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.