CHIMERIC ANTIGEN RECEPTOR (CAR)-T
Immuno-oncology treatments mobilize patient’s immune system to fight tumor cells. One of the approaches recently at the forefront of this therapy are chimeric antigen receptor (CAR)-T cells as a successful treatment modality for patients with leukemia or lymphoma. Immuno-oncology treatments have been approved by FDA in a variety of solid and hematological malignancies. A key advantage of using immuno-oncology therapy is the patient’s ability to fight recurrence more effectively.
With more than a decade of clients being served with CAR-T, TCR, TIL, and MSC manufacturing projects, Catalent is positioned to be your partner for commercial success. We are also at the forefront of continuous innovation in process development and optimizing the manufacturability of the new Natural Killer (NK) therapies. Catalent’s state-of-the-art Manufacturing by Design (MbD) methodology helps overcome many challenges associated with immune cell manufacturing. Our CGMP facilities across US and Europe are both regulated per FDA/EMA guidelines and deliver high-quality standards and process efficiency at production scale.
Almost all cell therapies in development or commercialization today target life threatening diseases, which severely impact the quality of life of the patient and their families. At Catalent, we employ a patient-first philosophy and share a commitment to rare disease patients and their future treatments.
T CELL RECEPTORS (TCR), TUMOR INFILTRATING LYMPHOCYTES (TIL)
Modified T Cell Receptors (TCR) are being investigated as a promising option for the treatment of solid tumors and virus infections. Efforts are underway to optimize the TCR alpha and beta transgene pairing to enhance the functional activity of the cell. Autologous therapies using Tumor Infiltrating Lymphocytes (TIL) are also being developed to treat solid tumors. There are an estimated 60 treatments in development ranging from preclinical to phase II stage that are utilizing TCR or TIL as a potential approach to target lymphoma, leukemia and various solid tumors. Catalent team has expertise through various programs underway in both TCR and TIL manufacturing from bench to commercial readiness phase.
NATURAL KILLER CELLS (NK)
There is a rapid growing interest in NK and CAR-NK cells for use in clinic primarily as they could offer some significant advantages including better safety profile in an autologous setting and limited induction of graft versus host disease. These emerging cell types offer new challenges in scale-up due to limited proof of principle in therapeutic setting.
Catalent has made significant investements in emerging modalities by implementing a strong innovation roadmap and extending both capacity and capabilities to drive process efficiencies at scale. Our state-of-the-art Manufacturing by Design (MbD) methodology helps overcome many challenges associated with allogeneic cell therapy manufacturing. With more than a decade of clients being serviced with broad portfolio of immune cell types, Catalent is better positioned as your partner to bring these emerging cell types to commercial phase with you. Our cGMP facilities across US and Europe are both regulated per FDA/EMA guidelines and deliver high quality standards and process efficiency at production scale. Our growing investments in cell types such as iPSCs is a testament to our strong commitment to be the leading provider in the next generation of cell therapies.