Research Excellence:
Our research unit collaborates closely with your team to establish differentiation protocols from scratch or optimize existing ones for enhanced efficiency and consistency.
Development Expertise:
Our development unit excels in translating proven differentiation protocols into cGMP processes. This encompasses both process and analytical development, as well as the construction of product specifications and target product profiles.
cGMP Prowess:
The cGMP unit stands ready to support your team in conducting cGMP-compliant production that spans manufacturing, QC release testing, QA review and release, and providing cGMP-compliant products essential for GLP animal studies and clinical trials.
Animal Studies Integration:
Our animal studies unit seamlessly integrates animal studies throughout the stages of research, development, and cGMP production. This integrated approach allows us to complete proof-of-concept studies and pre-GLP safety studies efficiently, all under one roof.
Donor Tissue Cell Sourcing:
Within the cGMP unit, we have established efficient processes for donor recruitment, screening, and informed consent. Contracted and qualified physicians can conduct common non-invasive tissue sample collection at our in-house clinics. These activities follow guidelines, plans, and SOPs reviewed and approved by IRB.
At Allele CDMO, our commitment to delivering end-to-end excellence extends beyond promises, as we actively support your stem cell product development journey at every critical juncture. Ensuring your success is our top priority.
Below is a general starting point for our featured service items. We have the expertise and experience to tailor solutions to your specific needs. Reach out to us via email at info@allelebiotech.com or the contact form above.