02.20.24 -- A Future Renaissance At Catalent? Employees Think So

A strategic switch in focus from a CAR T program closing in on the clinic, to a CAR M program further back in development but generating more excitement, drove the divesting of a manufacturing facility, and a whole lot of change. Part 2 of an investigative series.

The FDA recently released a draft guidance, Potency Assurance for Cellular and Gene Therapy Products. This article summarizes the draft guidance. The public comment period ends March 27, 2024.

There is a growing need for innovative solutions that reduce costs while maintaining high product quality. This poster presents investigations to derive an economic and scalable method for purification of AAV.

Advanced therapeutics are as complex as they are promising. Establishing a global regulatory strategy for these modalities requires a comprehensive, multifaceted approach.

Uncover guiding principles to ensure that your CGT supply chain is future-proof and learn how an agile, flexible approach can help advance your project with reduced costs and delays.

To meet the rising demand for plasmid DNA, discover why process scaleup and process optimization of current production processes is needed as both upstream and downstream challenges exist.

Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.

Review the advantages and limitations of transcriptional assays versus reporter gene assays and how the transcriptional assay compares to ddPCR and flow cytometry for analysis of CGTs.

Leveraging the technology, expertise, and capacity of a cell therapy CDMO is crucial to reduce timelines and lower costs as you bring your novel cell therapy from discovery to commercialization.

Take a look behind the scenes and hear firsthand about the commitment to patients and clients at Andelyn Biosciences.

Review how ensuring the consistency and yield of your plasmid production can help you de-risk the outsourcing process and ultimately reduce costs on your path to market.