Cell Therapy Solutions
With our cell therapy expertise and our focus on innovative, future-proofed solutions, we partner with you to address the challenges of complex cell therapy development and manufacturing scalability.
In an industry where rapidly generating clinical data can be the difference between advancing to Phase II or shelving a program, we can expedite your development and GMP timelines with our module-based, flexible platform solutions.
Flexible, Phase Appropriate Solutions
With the cost of goods (COGs) being ever critical, our solutions adapt to your requirements and phase, allowing you to meet your patients’ needs every step of the way. Our dedicated and integrated cell therapy facilities provide the ideal solution for your outsourced development and manufacturing requirements. From preclinical to commercial manufacture, we offer a full end-to-end service in a wide range of modalities.
As a form of regenerative medicine designed to repair damaged cells within the body, we are regularly developing tissue derived therapies in a wide range of stem cells, including, but not limited to:
- Mesenchymal Stem Cells
- Hematopoietic Stem Cells
- Induced Pluripotent Stem Cells (in partnership with FUJIFILM Cellular Dynamics)
Leveraging the immune system’s intrinsic ability to seek out and destroy abnormal cells is embedded in the history of our Cell Therapy Center of Excellence. We have a track record in both gene modified and non-gene modified immune cell therapies with the following cell types:
- Cytotoxic T Cells (CTL)
- Natural Killer Cells (NK)
- Chimeric Antigen Receptor (CAR)-T
- Tumor-specific T-cell Receptor (TCR)-T
Leverage our experience with trusted vendors to secure the appropriate tissue or cell starting material. When your program needs to scale up, our teams optimize solutions to produce volumes needed to treat your patient population. Identity is critical to an allogeneic program. To ensure our partners have the data needed to match their patients with therapeutics that will best serve them, we have established quality systems and relationships with external labs to maintain product identity and traceability, and to ensure data integrity.
Your patients provided the starting material, and it is critical that this material is handled correctly. From the moment our teams are notified of an incoming shipment, through production, testing, and ultimately the distribution of product back to the clinical site, attention to detail, experienced quality systems, and cross functional teams ensure the delivery of a safe, effective product to those who need it. Lot track and trace mechanisms and reliable, rapid, methodical responses to new production requests have been critical pillars of our systems from their inception.
End-to-End Cell Therapy CDMO Solutions
Benefit from the expertise, convenience and speed of a trusted, single source solution
Pre-Clinical
Phase I, II
Phase III
Regulatory Approval
Services
Our highly experienced Process Development and Manufacturing, Science & Technology (MSAT) teams support the development and optimization of world class cell therapy processes that meet your regulatory phase needs and goals.
Our scientists can develop, optimize and validate analytical methods to support client-specific assays – including safety and efficacy assays to enable successful transfer to our QC labs.
The depth and breadth of our Manufacturing, Science & Technology program ensures a seamless transfer of knowledge from our customers to the capable hands of our cGMP manufacturing teams.
When you partner with us, you benefit from:
- Expansive cGMP manufacturing space, complete with advanced technologies and electronic batch records to support clinical and commercial production goals at the highest quality.
- Experience-driven strategies and processes that enable program readiness and execution of manufacturing, disposition, and distribution activities – including supply chain, assembly, labeling, packaging and cryogenic storage.
Strategic Partnerships
FUJIFILM Cellular Dynamics, Inc.
FUJIFILM Cellular Dynamics offers contract development and cGMP manufacture of clinical-grade human cells to advance cell therapy programs. For over a decade, they have been the industry leader in the development, manufacturing, testing and distribution of high quality clinical-grade iPSCs and differentiated cells. Their expertise and capacity to produce iPSCs at commercial scale helps speed cell therapies to market.
RoosterBio
FUJIFILM Diosynth Biotechnologies and RoosterBio announced collaboration to enable cGMP Manufacturing of Cell and Exosome Therapies. RoosterBio offers process and analytical development of Mesenchymal Stem Cells (MSCs) and Exosomes (Extracellular Vesicles) followed by seamless tech transfer and transition to our cGMP Manufacturing Advanced Therapies facilities network.
