STEM CELL MANUFACTURING COMMERCIALIZATION
We understand the challenges encountered when translating cellular therapies from the bench to the bedside, especially when it comes to cGMP-compliant manufacturing and testing. Our specialized services in contract development and manufacturing can help smooth the transition from early-phase trials through clinical research pathways. Our expertise in process, facilities, equipment and regulatory/compliance can help you overcome unforeseen hurdles and the related time delays and cost overruns.
Our access to a large library of tissue sources allows for the isolation of a variety of tissue-derived stem and progenitor cells for your research needs. We provide:
- Bone Marrow
- Cadaveric tissue
- Umbilical cord blood
- Umbilical cord and placenta tissue
- Apheresis derived cell products
- Other cell and tissue sources
At GenCure we create cGMP-compliant, scalable processes for every phase of development. We are also experienced in developing and validating analytical test methods for product characterization and release testing. Our sister company, QualTex Laboratories, can provide in-house quality control services for the release testing of final products. Our development services include:
- Analytical methods development and validation
- Cell culture process development and scale-up
- Media development/optimization
- In-process testing
- Release testing
We have extensive experience in cGMP-compliant manufacturing of both tissue and cell-based products (allogeneic and autologous). Our facilities are designed to address your needs in pre-clinical and clinical-phase production through commercial manufacture. We can address your product labeling and document needs, prepare and approve all regulated documents prior to submission, and consult with regulatory agencies during audits. We have completed the technology transfer of RoosterBio’s hMSCs and all of the quality documentation is ready and prepared to support your regulatory filings. We offer:
- Pre-clinical manufacturing
- Early phase clinical-grade cGMP-compliant manufacturing
- Late phase and commercial cGMP-compliant manufacturing
- World-class quality systems
- Regulatory guidance
GenCure is equipped to manage cold chain processes for your cell banks and final cell products. We offer storage of cell-based products in vapor-phase liquid nitrogen. We use validated shipping processes for your global distribution requirements, and our dry shippers include temperature monitoring to help demonstrate the consistency of conditions during transit. Our services include:
- Fill and finish
- Storage and distribution
- Stability testing of master and working cell banks
OUR PARTNERSHIP WITH ROOSTERBIO INC.
Our one-of-a-kind partnership with RoosterBio Inc. allows us, as their preferred manfacturing partner, to start with a scalable manufacturing process for RoosterBio's cGMP-compliant, off-the-shelf hMSCs.
This reliable, well-tested source material, along with supporting Quality documentation, is ready for your use at GenCure. With the existing GenCure-RoosterBio CMC documentation and support as a foundation, we can significantly accelerate your IND submission process.
Simply tech transfer your novel process to us and move to first-in-man studies in a fraction of time.