Cell and Gene Outsourcing

  1. xRNA Production: The Economic Case For Continuous Manufacturing 10/31/2025

    See how a continuous manufacturing platform streamlines production to days, uses real-time quality control, and dramatically cuts costs to accelerate access to new therapies.

  2. Screening T7 Polymerases To Optimize xRNA Yield And Quality 10/31/2025

    Discover how the evolution of T7 polymerase is optimizing in vitro transcription for RNA therapeutics. Learn to balance performance, cost, and supply to make smart choices for your xRNA manufacturing.

  3. Method Optimization For Quantification Of Retroviral-Like Particles 10/30/2025

    Optimizing TEM for viral testing of high-protein unprocessed bulk material requires tackling sample preparation challenges. Using a smaller sample volume and long centrifugation can improve accuracy.

  4. Resistance And Chemical Inactivation Efficacy Of AAV, Other Parvoviruses 10/30/2025

    Minute Virus of Mice (MVM) is a more accurate surrogate for AAV2 inactivation. The high susceptibility of Porcine Parvovirus (PPV) may lead to an overestimation of disinfectant efficacy.

  5. Serotype Expansion Of GMP Platform Replication Competent AAV Method 10/30/2025

    Exploring the challenge of rcAAV testing for AAV serotypes beyond AAV2 is crucial for gene therapy safety. Serotype-specific factors impact infectivity, necessitating method refinement for reliable results.

  6. Highly Sensitive ddPCR Method For Detection Of Replication-Competent LVVs 10/30/2025

    A highly sensitive ddPCR assay targeting the VSV-g sequence allows for absolute quantitation and robust monitoring without product-specific qualification.

  7. The Power Of Next Gen Sequencing, Bioinformatics To Propel Viral Safety 10/30/2025

    NGS is a powerful, rapid method for comprehensive viral detection in biopharmaceuticals. Regulatory acceptance for non-targeted NGS is gaining momentum as an alternative to traditional testing.

  8. Evaluating Viral Clearance Trends In Biologics 10/30/2025

    AEX, Low pH, and viral filtration are the most robust viral clearance mechanisms. Low pH provides the highest overall LRV, while viral filtration is most effective when considering non-enveloped viruses. Future improvements will focus on process efficiency.

  9. Minimizing Volume Requirements, Turnaround Time For Compendial Testing 10/30/2025

    Effectively applying compendial testing to cell and gene therapy products requires strategic test ordering and specialized micro-equipment to manage limited volume and accelerate turnaround time.

  10. Trends Shaping The Future Of Cell And Gene Therapy Manufacturing 10/30/2025

    Discover how automation and digitalization are transforming cell and gene therapy with scalable, decentralized manufacturing and smarter market navigation.