Allele Cell Therapy CDMO delivers tangible end-to-end excellence, backed by our specialized laboratories
Product Development
We support cell therapy product development from early research protocols to robust, scalable, and regulatory-ready processes. Our services include process and analytical development, qualification and validation, scale-up and scale-out, and preparation for seamless transition into cGMP manufacturing.
Manufacturing Tech Transfer
We offer a structured tech transfer framework to support manufacturing with clients’ established processes. Through project initiation, gap analysis, phased transfer, installation, and risk assessment, we ensure alignment of critical process parameters and quality attributes for reliable cGMP production.
cGMP Manufacturing Operations
With ISO7-certified cleanroom facilities and over a decade of cGMP operational experience, we provide comprehensive manufacturing services for cell therapy products, including process installation, personnel qualification, production, finishing, packaging, storage, and distribution under a robust QMS.
iPSC Therapeutic Cell Sources
We provide cGMP-compliant iPSC cell sources to support cell therapy development and manufacturing. Our offerings include off-the-shelf iPSC lines, custom and autologous development, single-cell cloning, expansion, banking, and comprehensive quality control.
Integrated Quality & Science
Our integrated quality and scientific capabilities support cell therapy programs across development and manufacturing. We offer cGMP-validated QC testing, in-process and release testing, product characterization, and scientific studies to ensure quality, compliance, and program continuity.
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.
