June 06, 2024 |Taipei, Taiwan
Taiwan Bio-Manufacturing Corporation (Headquarters: Taipei, Taiwan; CEO: David Chang; hereinafter referred to as “TBMC”) and CMIC BIO Co., Ltd. (Headquarters: Minato-ku, Tokyo; CEO: Rin Sano; hereinafter referred to as “CBI”), a group Company of CMIC HOLDINGS Co., Ltd., have signed a non-binding Memorandum (“Memorandum”) for the marketing and customer service provision of TBMC’s proprietary CHO-C※1 cell-based antibody production technology and novel modality technology※2 in Japan.
In Japanese pharmaceutical companies and academia, facilities and technology constraints are a major hurdle. For those companies who do not have qualified environment for testing, they often use outside facilities or abandon in-house development and manufacturing when facing financial difficulties.
To address these issues, TBMC and CBI will jointly provide comprehensive support for the development and manufacturing of biopharmaceuticals by utilizing TBMC’s “HD CHO-C kit”, antibody production technology, and novel modality technology. We will meet the customer needs of biopharmaceutical development and manufacturing and related fields. The market is expected to continue growing.
With TBMC’s advanced technology support, CBI will be able to provide the following three services in Japan.
1. Sales service of “HD CHO-C kit”
The “HD CHO-C kit” provided by TBMC is a set of essential components to introduce target genes into CHO-C cells including a cloning vector, feed, medium, enhancer, gene transfection protocol, and CHO-C cells. This kit enables rapid protein production within 10 days in an environment with limited equipment and technology such as an in-house laboratory.
2. Outsourcing services for process development and batch manufacturing using CHO-C
With TBMC’s advanced technology support, we will be able to support CHO-C recombinant cell line construction and conduct cultivation and purification condition studies for antibody production, assisting in process development. Furthermore, we will proceed with scaling up from pilot-scale antibody production to the manufacturing of investigational drugs.
3. Consulting services for novel modality technology
We are available for consultations regarding technology development and manufacturing outsourcing by utilizing TBMC’s technology.
Taiwan Bio-Manufacturing Corporation (TBMC), conceived by the Ministry of Economic Affairs and jointly established by the Industrial Technology Research Institute (ITRI) and the Development Center for Biotechnology (DCB), officially commenced operations in May 2023. Dedicated to advancing biomanufacturing capabilities, TBMC partners with National Resilience, Inc. (Resilience), a technology-focused biomanufacturing company. Combining the expertise of National Resilience Inc. and Taiwan’s smart manufacturing capabilities, TBMC is dedicated to developing state-of-the-art solutions for the production of complex medicines, including (i)mRNA drug, (ii)viral vectors, (iii)cell therapy, and (iv)CHO-C protein pharmaceutical platforms.
TBMC operates from two primary manufacturing locations. Two Process Analytical Development Laboratories (PAD Labs; 1,820m2) are situated in the Taipei Bioinnovation Park and Hsinchu Biomedical Science Park. Both are slated for operational readiness and will have expanded operations in new facilities by June 2024 and December 2024, respectively. Meanwhile, the GMP plant (15,000m2) will be housed in the Hsinchu Biomedical Science Park and the facility will be commissioned and ready for GMP operation by the third quarter of 2025.
For more information, please visit their website.
CMIC BIO Co., Ltd. (CBI) is located in Shizuoka and has a GMP-compliant single-use facility for mammalian cell culture. Since October 2020, CBI has been providing process development and manufacturing contract support services for biopharmaceuticals. CBI offers consistent support services that prioritize communication with its customers, from initial process development to drug substance manufacturing and formulation, providing a reliable partnership.
For more information, please visit the website.
CMIC was founded in 1992 as the first contract research organization (CRO) in Japan. To enable pharmaceutical companies to develop better medicine sooner, we expanded our solutions to include contract development and manufacturing (CDMO), site support, and market solutions, supporting global companies to bring highly desired treatments to the Japanese market.
CMIC has also entered into the healthcare arena. Leveraging our vast experience and expertise in the medical industry, we offer solutions using a new ecosystem of healthcare to support individuals and local governments. We strive to be a Personal Health Value Creator (PHVC) to meet our global customers’ needs in the U.S., Japan, and broader Asia. CMIC Group has over 7,500 employees and 28 sites globally.
For more information about CMIC Group and services, please visit our website.