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.

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.

This year, the long-awaited FDA draft guidance for Platform Technology Designation Program was launched. This critical guidance allows drug developers to leverage Platform Technology data in approved drugs if similar “platforms” are used, accelerating the approval process and therapies to patients. In this webinar, George Buchman will discuss Catalent’s approach to platform processes as well as securing an integrated supply chain.

In this webinar learn how the GPEx® Lightning platform accelerates the high-titer production of next-generation multispecific antibodies and complex protein biologics

Biocapacitance technology is an online PAT tool for continuous monitoring of biomass in a mammalian or microbial bioprocess. In this paper, we show three applications of biocapacitance measurement technology.

This article discusses the development and establishment of Good Manufacturing Practice (GMP) compliant workflows for generating induced pluripotent stem cell (iPSC) lines and their differentiated progeny for cell therapeutic applications.

Catalent’s UpTempo℠ Antibody platform process combines the industry-leading GPEx® cell line development technology with streamlined, phase appropriate drug substance development to deliver products from early-stage development through CGMP manufacturing.

Cell-based assays play a critical role in assessing potency for traditional biologics and advanced therapeutics. For all analytical methods, increasing accuracy and precision while decreasing variability are critical to optimizing a method. For a cell-based assay, due to their biologic nature, the variable material inputs provide a challenge.

Cell-based assays play a critical role in assessing potency for traditional biologics and advanced therapeutics. For all analytical methods, increasing accuracy and precision while decreasing variability are critical to optimizing a method. For a cell-based assay, due to their biologic nature, the variable material inputs provide a challenge.

Cell-based assays play a critical role in assessing potency for traditional biologics and advanced therapeutics. For all analytical methods, increasing accuracy and precision while decreasing variability are critical to optimizing a method. For a cell-based assay, due to their biologic nature, the variable material inputs provide a challenge.