Even as manufacturing technologies advance for production and processing of gene therapies — with an overall goal of lowering the related cost of goods — so too are analytical methods developing and maturing for quality assurance and control. Market success for these advanced therapies depends on both process efficiency and product performance. Authors in this featured report examine the range of options available to gene therapy developers, from DNA synthesis to viral vector manufacturing, potency and other assays, design of experiments and multivariate analysis, useful sensors and instrumentation — and the valuable assistance that experienced consultants and contract players can provide.

Overcoming Obstacles in Viral-Vector Manufacturing: How To Design and Launch a Successful Program for Clinical-Trial Manufacturing

Mathias Kahl, Stephan Bauer, Thomas Kreisig, Rico Schmidt, Erik Arnold, Daniel Köhler, Tobias Thom, Christina Pospisil, Stefan Borutzki, Rico Hinrichs

October 24, 2023

1 Min Read

21-10-FR-SS-IDT-Cover-224x300.pngExperience with manufacturing viral vectors used for gene therapeutics is essential to mitigating risks in manufacturing of clinical trial materials. Collaborating with an experienced contract development and manufacturing organization (CDMO) with can help product developers design seamless and scalable vector-production processes. As authors from IDT Biologika describe here, a proven manufacturing platform and high-throughput analytical technologies help to ensure patient safety with products that meet high quality standards. The authors highlight the utility of digital polymerase chain reaction (dPCR), anion-exchange high-performance liquid chromatography (AEX-HPLC), size-exclusion chromatography with multiangle light-scattering (SEC-MALS), and next-generation sequencing (NGS) in gene therapy development.

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