Kalbio Global Medika
Kalbio Global Medika (KGM) is a pioneer in biopharmaceuticals in Indonesia, established in 2014 and part of the Kalbe Group. It is a state-of-the-art contract GMP biomanufacturing company specializing in mammalian cell use, with a focus on biologics and biosimilars. KGM aims to improve health through high-quality biopharmaceutical products, leveraging advanced technology and a robust facility to serve both local and international markets. The company is committed to operational excellence, innovation, and environmental sustainability, with certifications including ISO 14001:2015 and ISO 45001:2018, and has received numerous recognitions for its contributions to the industry.
Industries
Nr. of Employees
large (251-1000)
Kalbio Global Medika
Kawasan Industri Delta Silicon 3, Jl. Soka Blok F19 No. 002, Kel. Cicau, Kec. Cikarang Pusat, Kab. Bekasi, Jawa Barat 17530, Indonesia
Products
Efesa (efepoetin alfa)
Long‑acting erythropoietin active pharmaceutical ingredient and finished product for treatment of anemia associated with chronic kidney disease; API and finished product manufactured at the facility.
Rituximab (therapeutic monoclonal antibody)
Monoclonal antibody product available in multiple vial strengths for therapeutic use; produced and distributed as part of the facility's product offerings.
Serplulimab (anti‑PD‑1 immunotherapy)
Immunotherapy product launched for use in combination with chemotherapy for certain lung cancer indications; commercialized within the group.
Insulin glargine
Long‑acting insulin product included among the facility's manufactured biologics.
Other marketed biologics and specialty products
Additional biologics and specialty formulations for hematology, supportive care and oncology indications manufactured or listed by the organization.
Efesa (efepoetin alfa)
Long‑acting erythropoietin active pharmaceutical ingredient and finished product for treatment of anemia associated with chronic kidney disease; API and finished product manufactured at the facility.
Rituximab (therapeutic monoclonal antibody)
Monoclonal antibody product available in multiple vial strengths for therapeutic use; produced and distributed as part of the facility's product offerings.
Serplulimab (anti‑PD‑1 immunotherapy)
Immunotherapy product launched for use in combination with chemotherapy for certain lung cancer indications; commercialized within the group.
Insulin glargine
Long‑acting insulin product included among the facility's manufactured biologics.
Other marketed biologics and specialty products
Additional biologics and specialty formulations for hematology, supportive care and oncology indications manufactured or listed by the organization.
Services
cGMP manufacturing of biologics including integrated drug substance production and high‑volume fill–finish for vials, prefilled syringes and cartridges.
Contract QC and analytical testing for biologics, including assay development, method validation and routine release testing (ELISA, qPCR, endotoxin, sterility, cell‑based assays, chromatography).
End‑to‑end process development from upstream optimization to downstream purification, formulation development and pilot‑scale non‑GMP production; analytical method development and stability studies.
Provision of operational and site information to support third‑party feasibility studies, investor due diligence and early‑stage project evaluation.
cGMP manufacturing of biologics including integrated drug substance production and high‑volume fill–finish for vials, prefilled syringes and cartridges.
Contract QC and analytical testing for biologics, including assay development, method validation and routine release testing (ELISA, qPCR, endotoxin, sterility, cell‑based assays, chromatography).
End‑to‑end process development from upstream optimization to downstream purification, formulation development and pilot‑scale non‑GMP production; analytical method development and stability studies.
Provision of operational and site information to support third‑party feasibility studies, investor due diligence and early‑stage project evaluation.
Expertise Areas
- Biologics contract development and manufacturing
- CMC development and scale‑up
- Upstream and downstream bioprocess development
- Analytical method development and QC testing for biologics
Key Technologies
- Mammalian cell culture
- Monoclonal antibody production
- Upstream bioreactors (pilot to commercial scale)
- Downstream purification and chromatography
News & Updates
Vickers Venture Partners Perform Feasibility Study to PT Kalbio Global Medika
Ms. Linda Li, the Managing Director and one of the co-founders of Vickers Venture Partners, performed a feasibility study at KGM.
KGM Received Blue PROPER Rating From the Ministry of Environment and Forestry
KGM received its second Blue rating of PROPER from the Ministry of Environment and Forestry, showing commitment to environmental management practices.
Minister of Research and Technology Visits Three Kalbe Group R&D Laboratories
The Minister of Research and Technology visited Kalbe Group R&D laboratories, including KGM.
BPOM Conferred A GMP Certificate For Biotechnology Products Non-vaccine Upon KGM
In December 2021, KGM received a GMP certificate for biotechnology products from BPOM.
Minister of Industry Work Visit to PT Kalbio Global Medika
The Minister of Industry visited KGM as part of an official work visit.
General Atlantic US Invests US$55 Million in Kalbe Genexine Biologics
In September 2021, General Atlantic invested in Kalbe Genexine Biologics, which is associated with KGM.
Vickers Venture Partners Perform Feasibility Study to PT Kalbio Global Medika
Ms. Linda Li, the Managing Director and one of the co-founders of Vickers Venture Partners, performed a feasibility study at KGM.
KGM Received Blue PROPER Rating From the Ministry of Environment and Forestry
KGM received its second Blue rating of PROPER from the Ministry of Environment and Forestry, showing commitment to environmental management practices.
Minister of Research and Technology Visits Three Kalbe Group R&D Laboratories
The Minister of Research and Technology visited Kalbe Group R&D laboratories, including KGM.
BPOM Conferred A GMP Certificate For Biotechnology Products Non-vaccine Upon KGM
In December 2021, KGM received a GMP certificate for biotechnology products from BPOM.
Minister of Industry Work Visit to PT Kalbio Global Medika
The Minister of Industry visited KGM as part of an official work visit.
General Atlantic US Invests US$55 Million in Kalbe Genexine Biologics
In September 2021, General Atlantic invested in Kalbe Genexine Biologics, which is associated with KGM.