Advanced CDMO Human Resource Development Program

This program provides a systematic learning environment for acquiring the knowledge and skills necessary to work in the fields of regenerative medicine and biopharmaceuticals.

Currently, with the increasing demand for cutting-edge medical products (ATMPs) and technologies such as regenerative medicine, cell therapy, and gene therapy, there is a growing need for "CDMOs (Contract Development and Manufacturing Organizations)" that are responsible for developing their manufacturing processes and actual production. The government is therefore focusing on training specialized CDMO personnel.

Therefore, Nakanoshima Qross has been developed as a "Highly Advanced CDMO Human Resource Development Center" and has started offering its training programs.
This program provides a systematic approach to learning the knowledge and skills necessary for working in CDMOs, regenerative medicine, and biopharmaceuticals, from the basics to practical application levels.

In addition to developing personnel involved in manufacturing, quality control, and process development, we aim to cultivate individuals and technical sales personnel who can meet client needs and manage goals through smooth communication with clients.

Eight features of this program

1

Suitable for beginners to administrators.

A wide range of programs tailored to your skills and experience, from on-site operators to facility managers.
2

Developing highly specialized and effective personnel

In addition to manufacturing and quality control, we cultivate process development personnel equipped with specialized knowledge.
3

From the fundamentals to the applications of process design

This will enable a systematic understanding of the various characteristics that should be considered in process development, which affect raw materials, the environment, and the cells involved in the work.
4

Reducing the burden of in-house training by providing content based on the latest information.

It can also be used for regular education and training on regulatory systems, basic hygiene management techniques, and the fundamentals of aseptic technique.
5

Deepen your understanding through in-person training.

You can acquire skills and knowledge thoroughly in a focused environment through practical, face-to-face training.
6

Gain practical insights

A practical and cutting-edge program based on the experience and knowledge accumulated at Nakanoshima Qross.
7

Supports mass production, automation, and QbD.

It covers everything from process scaling and automation to quality design based on Quality by Design (QbD).
8

Well-equipped faculty

The lecturers at Nakanoshima Qross include representatives from academia, corporations, and regulatory/administrative authorities.

List of upcoming courses

Basic knowledge and basic skills	An Introduction to Laws and Regulations Related to Regenerative Medicine
	Advanced Topics in Legal Regulation
	Research ethics
	Basic Life Sciences I (Basic Cell Biology, Molecular Genetics)
	Basic Life Sciences II (Development, Tissue Formation, Stem Cells)
	Basic Life Science III (Microbiology, Introduction to Immunology)
	pluripotent stem cells
	iPS Cell Culture Practice
	Basic aseptic techniques (introductory level)
	Basic aseptic techniques (beginner level)
	Microbial hygiene management I (cleanroom)
	Microbial Hygiene Management II (Maintaining a sterile working environment and contamination control)
	Microbial Hygiene Management III (Specialized Practical Training for Environmental Maintenance)
	Sterility testing methods
	Endotoxin test
	Mycoplasma test
	Flow cytometry and cell counting and quality testing
	PCR and quality testing
	Cell freezing and storage / Handling of high-pressure gases
Manufacturing and Inspection Management	Requirements and basic terminology related to manufacturing quality control
	Systematic organization of regulatory requirements
	International Trends and Latest Topics
	basic manufacturing management
	basic quality control
	Quality testing and sampling strategies
	Basics of Regenerative Medicine Development for CDMO Sales Professionals
Process development	Introduction to Process Development
Process development	Advanced Topics in Process Development

*The content is subject to change.
*The start date will be announced as soon as it is decided.
(As of March 2026, 7)

Target

For companies and healthcare professionals involved in regenerative medicine.
For startup companies involved in regenerative medicine
For those who want to find employment or advance their careers in the CDMO, regenerative medicine, and biotechnology fields.
Those who want to learn about the industry in order to start a business
For those who want to understand the overall picture of manufacturing, quality, testing, and development.
Management personnel who want to systematically understand regenerative medicine, etc.

Benefits of studying this program

If you are taking the course individually

You can systematically learn the fundamentals of your work, even if you're proceeding with it in a vague or unclear manner.
You will acquire practical skills that will make you immediately valuable in manufacturing and quality control, including aseptic techniques, cleanroom management, and quality testing.
You can learn about the latest regulations and topics in a way that is relevant to practical work.
A certificate of completion can demonstrate expertise.

When used as an in-house training program

Standardizing new employee training significantly reduces training costs and time.
Eliminate skill disparities and reliance on individual expertise on the job site, and reduce quality risks.
Strengthening our ability to comply with GCTP, PIC/s GMP, and other standards will enable smoother audit responses.
We can cultivate the specialized personnel necessary for next-generation CDMO businesses.