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

• Process Considerations For Closed Connected Processing

  By giving examples for the implementation of closed, connected processing in large-scale manufacturing, this paper will help you explore and assess options that work for your objectives.

• Registry And Natural History Studies: Vital, Contrasting Roles In Rare Disease Clinical Research

  Both registry studies and natural history studies play important roles in rare disease research. Understanding the differences between the two types of studies and how they can be used to inform clinical development can help sponsors plan for success.

• Using Single-Use Connectors To Increase The Integrity Of Closed Systems

  It is critical the single-use sterile connectors you select meet the sterility and reliability needs of your application, as minimizing the threat of contamination using a closed system is essential.

• Downstream Process Intensification With Novel Chromatography Resins For Enhanced mAb Purification

  Using its PROchievA protein A affinity resin with select additives, Avantor has designed an integrated mAbs downstream purification process to enable significant throughput improvement while removing critical impurities.

• CRISPR/Cas9-mediated PD-1 Knock-out In Human Primary T Cells Shows Enhanced Cytotoxicity Against Cancer Cells

  The existence of an adaptive immune system in single-cell organisms was debated for a long time until the CRISPR/Cas9 mechanism had been identified. In this study, the CRISPR/Cas9 system was used to knock-out PD-1 gene expression in human primary T cells.

• AAV Production Using Microcarriers

  Scientists have successfully adapted an adherent HEK293 cell line to grow in animal component-free and serum-free suspension conditions in shaker flasks. After comparing adherent, suspension, and microcarrier culture for AAV production, they believe that microcarrier culture is suitable for large-scale production of viral vectors to support future gene therapy manufacturing processes.

• Recombinant Collagen Via Fermentation: Safety, Sustainability, Acceptability

  The production of recombinant collagen made via fermentation-based processes addresses the market need for collagen that is safe, sustainable, reproducible, and acceptable to consumers.

• Vaccine Production Process Development: 4 Best Practices For Scaling Up

  The vaccine production process is continually refreshed by new tools and technologies which imposes challenges on process development scientists: They're the ones who have to align and optimize new methods and means with legacy products and systems. By carefully crafting a customized modular process from end to end, process development scientists can glean the benefits of new technologies without starting from scratch with each new iteration. How can researchers working on vaccine production optimize their process with customization in mind?

• Bioprocess Media Pooling Case Study

  How a sterile, closed system created process efficiency by removing the need for a biosafety cabinet, and enabling the manipulation of pre-sterilized assemblies in a more comfortable, ergonomic setting.

• Security Of Supply In Cell And Gene Therapy Manufacturing

  With so many challenges in cell and gene therapy manufacturing, building an adequate supply chain with the necessary equipment and protocols is critical for companies pursuing these life-saving drugs.