Cultivecs
Cultivecs Inc. is a company that develops and manufactures antibody drugs, aiming to contribute to society through the stable supply of high-quality, low-cost biopharmaceuticals using state-of-the-art technology. The company was established in 2016 and operates a GMP-compliant manufacturing facility in Niigata, Japan, with a focus on antibody drug development and manufacturing, including contract manufacturing services. Cultivecs is committed to providing efficient, high-quality biopharmaceuticals by utilizing advanced manufacturing techniques and maintaining close communication with clients.
Industries
Nr. of Employees
small (1-50)
Products
マスターセルバンク（MCB）、ワーキングセルバンク（WCB）製造
日米欧3極に対応した製造設備におけるマスターセルバンクおよびワーキングセルバンクの受託製造サービス。
バイオ医薬品原薬製造（前臨床用サンプル、治験薬、市販薬）
シングルユース設備を導入した培養から精製におよぶバイオ医薬品原薬の受託製造サービス。
Antibody Drug Manufacturing and Process Development Services
Comprehensive one-stop service covering initial process development, GMP manufacturing, clinical trials, and development strategy for antibody drugs utilizing single-use equipment.
バイオ医薬の受託製造
抗体医薬を中心としたバイオ医薬の企画、国内製造受託事業を展開します。
製造プロセス検討・各種分析サービス
バイオ医薬品製造に関連するプロセス検討や、工程分析、出荷試験、安定性試験などの各種分析サービス。
マスターセルバンク（MCB）、ワーキングセルバンク（WCB）製造
日米欧3極に対応した製造設備におけるマスターセルバンクおよびワーキングセルバンクの受託製造サービス。
バイオ医薬品原薬製造（前臨床用サンプル、治験薬、市販薬）
シングルユース設備を導入した培養から精製におよぶバイオ医薬品原薬の受託製造サービス。
Antibody Drug Manufacturing and Process Development Services
Comprehensive one-stop service covering initial process development, GMP manufacturing, clinical trials, and development strategy for antibody drugs utilizing single-use equipment.
バイオ医薬の受託製造
抗体医薬を中心としたバイオ医薬の企画、国内製造受託事業を展開します。
製造プロセス検討・各種分析サービス
バイオ医薬品製造に関連するプロセス検討や、工程分析、出荷試験、安定性試験などの各種分析サービス。
Services
Manufacture of antibody active pharmaceutical ingredient (API) for preclinical, clinical, and commercial supply using GMP-compliant processes.
Production and handling of master and working cell banks to support biologics manufacturing and technology transfer.
Process evaluation and optimization to support transfer from development to GMP manufacturing, including upstream and downstream process studies.
In-process monitoring, release testing, stability testing, and analytical method development/validation for biopharmaceutical products.
QA functions including SOP/document control, change and deviation management, audits, training, and inspection support aligned with GMP requirements.
Coordination with partner organizations to provide services spanning cell line development, preclinical support, GMP manufacturing, and clinical supply.
Manufacture of antibody active pharmaceutical ingredient (API) for preclinical, clinical, and commercial supply using GMP-compliant processes.
Production and handling of master and working cell banks to support biologics manufacturing and technology transfer.
Process evaluation and optimization to support transfer from development to GMP manufacturing, including upstream and downstream process studies.
In-process monitoring, release testing, stability testing, and analytical method development/validation for biopharmaceutical products.
QA functions including SOP/document control, change and deviation management, audits, training, and inspection support aligned with GMP requirements.
Coordination with partner organizations to provide services spanning cell line development, preclinical support, GMP manufacturing, and clinical supply.
Expertise Areas
- Contract manufacturing (CMO) for antibody therapeutics
- GMP manufacturing for biologics
- Upstream mammalian cell culture at scale
- Downstream purification and process scale-up
Key Technologies
- Single-use bioreactors (200 L–2,000 L scale)
- Large-scale mammalian cell culture
- Downstream purification (chromatography-based workflows)
- Master/working cell bank production
News & Updates
Representative Director, President Takao Ota's appointment
On June 10, 2020, Takao Ota was appointed as the President of Cultivecs Inc.
Participation in research project by AMED
Cultivecs participated in a research project conducted by the Japan Agency for Medical Research and Development (AMED) in 2021.
Joining the Next-Generation Biopharmaceutical Manufacturing Technology Research Union
Cultivecs joined the research union on June 25, 2021, focusing on next-generation biopharmaceutical manufacturing technologies.
Compliance consultation window established
The company established a compliance consultation window on October 28, 2021.
Address publication of Niigata factory
The address of the Niigata factory was published on July 26, 2018.
Designation as a target project for Niigata City Industrial Promotion Subsidy
The Niigata City Industrial Promotion Subsidy program designated Cultivecs' project on August 23, 2018.
Representative Director, President Takao Ota's appointment
On June 10, 2020, Takao Ota was appointed as the President of Cultivecs Inc.
Participation in research project by AMED
Cultivecs participated in a research project conducted by the Japan Agency for Medical Research and Development (AMED) in 2021.
Joining the Next-Generation Biopharmaceutical Manufacturing Technology Research Union
Cultivecs joined the research union on June 25, 2021, focusing on next-generation biopharmaceutical manufacturing technologies.
Compliance consultation window established
The company established a compliance consultation window on October 28, 2021.
Address publication of Niigata factory
The address of the Niigata factory was published on July 26, 2018.
Designation as a target project for Niigata City Industrial Promotion Subsidy
The Niigata City Industrial Promotion Subsidy program designated Cultivecs' project on August 23, 2018.