Partnering in Biopharmaceutical Development & Manufacturing.
DM Bio is a biopharmaceutical company specializing in the R&D and production of therapeutic proteins and monoclonal antibodies based on mammalian cell culture. DM Bio developed as a joint venture of Dong-A Socio Holdings and Meiji Seika Pharma, which both has long history in pharmaceutical industry in Korea and Japan, respectively. Since its first manufacture in 2015, DM Bio dedicates itself to match specific demands of global biotechnology companies with highly qualified experts and the state-of-the-art manufacturing capacities. Whether it is through strategic collaboration or CDMO service, DM Bio takes pride to satisfy their clients with excellent service and products.
DM Bio has two business focuses. First, DM Bio is open for strategic collaboration for out-licensing their outstanding biosimilar pipeline. Second, DM Bio acts as a biopharmaceutical contract development manufacturing organization (CDMO) specializing in the production of therapeutic proteins and monoclonal antibodies based on mammalian cell culture.
DM Bio is actively seeking global partners for out-licensing/co-development of our in-house developed Herceptin and Stelara Biosimilar candidates. Based on our in-depth experience and know-hows, DM Bio is in strategic partnerships with global biopharmaceutical companies for Herceptin Biosimilar Candidate and Aranesp Biosimilar Candidate for out-licensing and co-development in the US, EU, and Japan markets.
To take a step forward, DM Bio is actively seeking for partnership with promising partners for the development of the following blockbuster biosimilars globally.
*DM Bio's Biosimilar Pipeline.
DM Bio's excellent mAb biosimilar pipeline based on many years of R&D experience is open for discussion.
-DMB-3111 (Herceptin Biosimilar Candidate): Completed Phase I clinical study. Actively seeking for US, Chinese and Asian partners for out-licensing.
-DMB-3115 (Stelara Biosimilar Candidate): Preclinical stage. Actively seeking for partners to co-develop in the global markets.
-DA-3880 (Aranesp Biosimilar Candidate): Japanese phase III trial on-going. Preparing for global phase III study.
DM Bio is capable of developing a wide range of processes for a variety of cell lines that are transferred from clients to our facility.
-Process development of cell culture
-Process development of purification
-Process validation & transfer
*Mammalian Cell Culture-Based cGMP Manufacturing.
DM Bio strives to provide products for clients’ most challenging projects.
-Total capacity : 8,000L
-2,500L multi-use bioreactor (x3)
-20, 50, 200, 500L single-use bioreactor (x4)
-AKTA process (x5)
*Aseptic Fill & Finish.
DM Bio has its strengths in producing aseptic pre-filled syringes with their cutting-edge facility.
-Pre-filled syringe line (10,800 Syringes/Hr)
-Vial line (Planned)
-Secondary Packaging (3,000 Blisters/Hr)
*Quality and Regulatory Support.
DM Bio’s quality system adheres to global regulations including ICH, PIC/S and cGMP. We also assist clients in complying with the appropriate regulatory requirements.
DP: GMP Certification from MFDS (2017.03)
500L DS: GMP Certification from MFDS (2016.11)
2,500L DS: GMP Certification from MFDS (expected in 2018.1H)