UpTempo℠ Antibody Platform Process

Leverage our proven UpTempo℠ Antibody platform process & deep expertise to quickly develop a robust, highly productive CGMP process to accelerate your antibody therapy to the next milestone.

CATALENT’S UPTEMPO℠ ANTIBODY PLATFORM PROCESS ENABLES ACCELERATED TIMELINES FROM GENE TO CLINIC WITHIN 11 MONTHS*

UPTEMPO℠ ANTIBODY PLATFORM PROCESS TIMELINE

DEVELOP A ROBUST, SCALABLE GMP MANUFACTURING PROCESS FOR CLINICAL TRIALS

The UpTempo℠ Antibody platform process provides a solution to address key challenges when bringing your preclinical program to the clinical stage. With the UpTempo℠ Antibody platform we can develop a process to maintain high productivity and ensure product quality, scalability, and reproducibility. The process begins with the gene construct synthesis, followed by the creation of stable, high-yielding mammalian cell lines using the industry-leading GPEx® technology with elevated yield up to 15 g/L. As the program progresses through process & analytical development, time is saved through parallel development with application of proven tools & well-understood process conditions, as well as our extensive expertise & decades of experience in upstream / downstream process development & process characterization / validation. Drug substance manufacturing is scaled from process development to GMP in state-of-the-art facilities offering the right scale fit for your program.

*The 11-month timeline claim applies for traditional monoclonal antibodies (mAbs).