CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Genome Integrity Analysis Of AAV Using Multi-Capillary Gel Electrophoresis

  We demonstrate that multiple AAV samples with different serotypes or different genome sizes can be run simultaneously on the multi-capillary system to accelerate the execution of sensitive, AAV genome integrity analysis.

• Dilution Of Multiple Buffer Concentrates With One Single-Use Flow Path

  The Allegro™ connect buffer management system is suitable for application with capture, purification and polishing chromatographic operations. Furthermore, the system can provide a continuous supply of multiple in-specification diluted buffers with minimal downtime and is suitable to support continuous operations such as multi-column chromatography and multi-buffer filtration operations.

• Characterization Of AAV-Based Viral Vectors With Batch Static And Dynamic Light Scattering Instruments

  Quantify aggregate content, thermal stability, and total viral particle concentration with batch static and dynamic light scattering (SLS and DLS) techniques.

• Nucleases - Are They A Problem For NAB Nanosep® Centrifugal Devices?

  We examine whether the sample tubes and collection tubes of the NAB Nanosep centrifugal devices contain detectable amounts of DNase or RNase.

• The Stabilization Of hMSCs As A Technology

  Explore how the Gartner Hype Cycle™ model of the maturity and adaptation of technologies, illustrates the rise of the MSC, the fall from grace after multiple failed clinical trials, and what we consider, the stabilization of hMSCs as a true biotechnology.

• A Guide To Accelerating Cell Line Development For Commercial Production

  Explore the challenges associated with cell line development in the production of biologics, and solutions that can help biotech developers evade the pitfalls of misinformed decision-making.

• Developing Advanced Therapies: Considerations For Internal Versus External Manufacturing

  Due to their complexity and cost, developers of cell and gene therapies face unique manufacturing hurdles. Determining the right approach to manufacturing is crucial when bringing these advanced therapeutics from clinical to commercialization. This paper provides a distinct perspective on how to approach manufacturing and other roadblocks at every stage of development.

• A Five-Point Strategy For Building A CMC Dossier

  By adopting strategies to build a robust CMC package to help streamline the path to FIH trials, innovators can establish a quality foundation to support the development phases toward commercialization.

• Gene Therapies: Building Facilities, Commercializing Product And Industrializing The Footprint

  A clinical-stage company was focused on bringing their gene therapy from the lab into a clinical setting for patients and families devastated by rare neurological genetic diseases. They needed a partner to help them pioneer the industrialization of gene therapies and build a cutting-edge manufacturing facility using modular cleanrooms, emerging bioreactors and single-use technologies for the clinical and commercial manufacture of a life-saving gene therapy for a rare neurological disease.

• Upstream Platform For Continuous Lentiviral Vector Production

  Here, we demonstrate a high-yield LV production process, using animal-derived component-free media and reagents, where multiple or continuous vector harvests could be obtained from a single batch.