Streamline AAV-Based Gene Therapies with High-Performing Off-the-Shelf Plasmids
AAV gene therapy programs face long development cycles, raw material variability, and complex scale-up demands.
The Growing Strategic Importance of CDMOs in Cell & Gene Therapy
Summary: Cell and gene therapies continue to expand across oncology, cardiovascular, and CNS diseases, yet production remains limited by talent shortages, complex supply chains, and slow development cycles.
Integrating DNA Sequencing and AI for AAV Genome Integrity
AAV genomic integrity is based on defining the molecular DNA composition of recombinant AAV vector preparations, specifically, the presence of full-length, ITR-to-ITR genomes, and the relative amount of undesirable molecular sub-species encapsidated within AAV particles.
UpTempo(SM) Plasmid Platform Seamless Transitions from Bench to CGT Applications
Plasmid DNA is a vital component in the production of viral and nonviral cell and gene therapies (CGT). Catalent’s innovative UpTempo℠ Plasmid Platform Process has revolutionized plasmid DNA manufacturing by addressing key challenges and significantly reducing development time.
UpTempo℠ Plasmid DNA Platform
Summary: Catalent has successfully addressed the challenges associated with plasmid DNA manufacturing by developing robust process and analytical platforms. Catalent’s approach involves a one-process-fits-all single-use (SU) manufacturing process in compliance with current good manufacturing practices (cGMP) standards.
Speed Your Path to Patients with Integrated Solutions for Plasmid DNA Development & Manufacturing
Summary: Catalent offers extensive expertise in the bioproduction of plasmid DNA, from early stages of development to CGMP manufacturing to satisfy clinical and commercial needs.