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
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
Commercial Manufacturing (CMO)
cGMP manufacturing of biologics including integrated drug substance production and high‑volume fill–finish for vials, prefilled syringes and cartridges.
Toll‑in Testing (QC services)
Contract QC and analytical testing for biologics, including assay development, method validation and routine release testing (ELISA, qPCR, endotoxin, sterility, cell‑based assays, chromatography).
Process and Analytical Development
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.
Feasibility study support and investor engagement
Provision of operational and site information to support third‑party feasibility studies, investor due diligence and early‑stage project evaluation.
Commercial Manufacturing (CMO)
cGMP manufacturing of biologics including integrated drug substance production and high‑volume fill–finish for vials, prefilled syringes and cartridges.
Toll‑in Testing (QC services)
Contract QC and analytical testing for biologics, including assay development, method validation and routine release testing (ELISA, qPCR, endotoxin, sterility, cell‑based assays, chromatography).
Process and Analytical Development
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.
Feasibility study support and investor engagement
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