Bridging the Gap: Streamlining iPSC-Derived Cell Line Development from Donor Cells to MCB
Allogeneic iPSC-derived therapies hold immense promise, offering scalable, off-the-shelf solutions for a wide spectrum of diseases. However, the journey from donor cells to a gene edited, clinically compliant GMP Master Cell Bank (MCB) is fraught with challenges and is particularly vulnerable to risks stemming from misaligned early development.
A major bottleneck seen in the majority of iPSC therapeutic programs arises when development teams continue to rely on R&D grade cell lines to confirm proof-of-concept, conduct preclinical animal studies, and to start process & analytical development. [Read more…]
RoslinCT and Ayrmid Pharma Enter Into a Strategic Partnership to Manufacture FDA Approved Cell Therapy Omisirge® (omidubicel-onlv)
Intent that RoslinCT is to perform technology transfer and commercial manufacture of Omisirge® at RoslinCT’s cell therapy manufacturing facility in Hopkinton, MA.
Omisirge® is a commercialized mismatched unrelated cell therapy derived from the youngest donor source and banked for ease of infusion for patients with hematological malignancies.
Key Strategies for Positioning Cell Therapy CDMO Services – Size & Specificity
A contract development and manufacturing organization (CDMO), is a company that serves cell therapy companies on a contract basis. Common cell therapy CDMO services include cell therapy product development, manufacturing, clinical trial support, and commercial supply.
CDMOs allows cell therapy companies to outsource aspects of their business, which can support:
- Scalability
- Speed to market
- Adding technical expertise without overhead costs
- Cost efficiencies
Cell Therapy Manufacturing: Factors Driving Interest in Cell Therapy CDMOs
Cell therapy manufacturing is becoming of growing importance as more and more cell therapeutics make their way through clinical trials. One of the major issues with moving cell therapy products from “bench to bedside” has been manufacturing bottlenecks. The heterogeneous nature of cell therapy products has introduced manufacturing complexity and regulatory concerns, as well as scale-up complexities that are not present within traditional pharmaceutical manufacturing.
Cell Therapy Manufacturing CDMOs
While these realities may sound like negative factors for the industry, the reality is quite the opposite. For cell therapy CDMOs, these factors create pressures for cell therapy companies to seek third-party partners who possess technical, manufacturing, and regulatory expertise in cell therapy development and manufacturing. [Read more…]




