MANUFACTURING ARTICLES

MANUFACTURING VIDEOS

In this Bioprocess Online Live panel discussion, we talk about where the greatest sources of variability are in our downstream processes and how companies should be approaching the question of “how pure is pure enough?"

In this segment from the Surge Manufacturing for Biopharma Resilience live event, University of Sheffield’s Dr. Zoltán Kis shares the work he’s doing on the Wellcome Leap RNA R3 program.

Nutcracker Therapeutics is a preclinical biopharma company developing multimodal RNA-based therapeutics for HPV-driven tumors, T-cell lymphoma, and Genitourinary tumors. On this episode of the Business of Biotech, Chief Business Officer Geoff Nosrati, Ph.D. offers a comprehensive view of the RNA-based therapeutics landscape and sheds light on what he perceives as an advantageous position at Nutcracker — the capacity to manufacture RNA in-house. If you're curious about the expanding science behind RNA-based therapeutics and their application in biotech, this conversation with a scientist-turned-chief business officer (Nosrati earned his Ph.D. in Biochemistry and Molecular Biology) is a can't-miss episode.

The clinical promise of mRNA therapeutics and vaccines is clear, but compared to monoclonal antibodies or viral vectors, their novelty also brings new challenges to the manufacturing process.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

  • Precise enzyme selection in IVT reduces dsRNA byproducts and boosts capping efficiency. This ensures high-quality mRNA production while easing the burden of complex downstream purification processes.

  • Explore how Difco™ TC Yeastolate ultra-filtered (TCY UF) enabled over 100% improvement in titer for CHO cell culture through feed optimization and bioreactor scalability in a real-world application.

  • As the demand for plasmid DNA (pDNA) based gene therapy and vaccines increases, large-scale, cost-effective, and reproducible pDNA production is required. The key to success is a real-time in-process control method that ensures a high percentage of supercoiled pDNA in the final product. Read how the CIMac™ pDNA Analytical Column allows the monitoring of degradation products (open circular and linear pDNA), the removal of impurities (RNA), and ensures that each production step yields the amount of supercoiled pDNA anticipated.

  • Batch processing platforms for LNPs lack efficiency, appropriate controls, and yield optimization. Continuous manufacturing platforms may address some of those issues.

  • Learn how a single cell dispenser was used to isolate single DNA-labeled nuclei to demonstrate compatibility with snRNA-seq workflows.

  • Choosing the right mRNA manufacturing model can define your success. Learn how to weigh control, cost, and flexibility to build a strategy that supports innovation and long-term growth.

  • Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.