service
Four service areas to support every step from concept to clinical application
service
Cell bank/cell raw material cooperation
Provide clinical-grade MSC cell bank establishment and management solutions.
Co-development of indications
Assisting in the development of other degenerative or injury-related diseases
Cell-based drug development and manufacturing organization (CDMO)
Provides cell process development, scale-up and optimization services
Testing and Regulatory Consulting
Provide professional services in quality testing and regulatory consultation.
Stem cell exosome cosmetics development
Developing high-end skincare products using MSC exosome technology
Cell bank and cell raw material cooperation
- Provide solutions for establishing and managing cell banks that meet clinical-grade standards.
- We can provide cell lines, frozen samples, or process technology transfers based on our partners' needs.
- Assist existing cell banks in risk assessment and upgrade planning (such as standardization, documentation, and the establishment of quality standards).
- Depending on the cooperation model, we will discuss different cooperation structures such as long-term supply, joint development, or licensing.
Co-development of indications and IND strategy planning
- Based on existing development experience in "frailty and spinal cord injury", we can help extend to other degenerative or injury-related diseases.
- For the target indication, conduct literature and competitor analysis, and assess medical needs and market size.
- Assist in planning the design of preclinical studies and setting key endpoints.
- We provide assistance with the technical documentation required for IND or clinical trial applications, including CMC and some non-clinical content.
- Collaborate with regulatory advisors and clinical teams to develop a feasible regulatory pathway.
Cell formulation CDMO and process development
- We provide cell process development, scale-up, and optimization services tailored to different indications and trial designs.
- Assist in establishing batch release standards, stability testing protocols, and quality management plans.
- We collaborate with partner organizations that possess GTP/GMP capabilities to manufacture cell preparations for clinical trials.
- If the partner has its own facilities, we can provide consulting services on technology transfer and process implementation.
Testing and Regulatory Consulting Services
- We provide advice on cell product identification, functional testing, and safety testing.
- Assist in planning the document structure of the Quality Management System (QMS).
- We provide initial consultation and project-level advisory services in accordance with regulatory requirements related to cell therapy.
- Connect with clinical, regulatory, and statistical experts as needed to form cross-disciplinary teams.
Stem cell exosome cosmetics development
- Develop high-end skincare products using exosomes secreted by NK and MSC.
- Exosomes contain abundant growth factors, cytokines, and microRNAs, which can promote skin repair and anti-aging effects.
- We provide complete technical support from exosome preparation and quality testing to formulation development.
- We can collaborate with cosmetic manufacturers to provide exosome raw materials or jointly develop branded products.
- Complies with cosmetic regulations to ensure product safety and compliance.
The complete pathway from initial consultation to clinical trials
service process
Preliminary consultation
01
Understand the background, clinical setting, and development goals of the collaborating units. Clarify the requirements for the MSC cell bank and process platform.
02
Technical and regulatory feasibility assessment
Conduct preliminary literature and market analysis. Examine the feasibility of the target indication and development timeline.
03
Project design and collaboration model confirmation
Jointly define the project scope, milestones, and projected timeline. Confirm the responsibilities and cooperation framework of both parties.
04
Process and Cell Bank Implementation Stage
Establish cell banks, develop processes, and set key quality standards.
05
IND/Clinical Trial Application Support
Assist in preparing relevant technical documents and integrating relevant data. Collaborate with regulatory advisors and the clinical team to complete document submission.
06
Technical support during clinical trials
We will continue to provide cell preparations, quality monitoring, and technical consultation. We will adjust our follow-up strategies based on trial results and feedback from regulatory authorities.
FAQs
Does Chi-Chi Biotech currently possess a clinical-grade MSC cell bank?
We have established a clinical-oriented MSC cell bank structure and continue to expand the batches and testing items according to the needs of different development projects. At the same time, we are connecting with partners with GTP/GMP capabilities to meet the needs of future clinical trials and IND submissions.
If we already have our own cell bank, can we still collaborate with Qiqi?
Yes. Qiqi can assist in assessing the quality and risks of existing cell banks, and make adjustments or upgrades to processes and documentation. It can also provide supplementary or alternative cell sources when necessary, and work together to design the most suitable development strategy.
How long does it typically take for a collaborative project to enter the IND (Investigational New Drug) submission stage?
The timeline will vary depending on the indications, the amount of existing data, and the regulatory requirements of each country. Generally speaking, from initial assessment, to meeting the requirements for submission and obtaining an IND, it may take several months and several development phases. We will provide an initial timeline at the beginning of the collaboration and will adjust it as the project progresses.
