Insights On Upstream Manufacturing

  1. Viral Vector Production Series
    8/16/2019

    In our tutorial series on viral vector production, GE scientists share their insights on virus production and how to tackle viral vector manufacturing challenges. In one episode a scalable production process for adenovirus is presented.

  2. Tips For Viral Vector Production
    8/7/2019

    The viral vector market is highly active, and the interest in production technologies is driven by recent approvals in cell and gene therapy. Here, insights around the challenges in viral vector manufacturing are shared so that a scalable and cost-efficient process suitable for GMP manufacturing environments can be obtained.

  3. How To Adapt Your Existing Biomanufacturing Process To Maximize Production
    7/26/2019

    Achieving “smarter”, more flexible workflows requires a complete understanding of today’s novel solutions and technologies, which, when applied appropriately, can push the boundaries of drug development and offer critical advantages in an increasingly competitive industry. 

  4. Intensified Chromatography Strategies
    7/26/2019

    With a newer toolbox of options to intensify downstream manufacturing operations, it is important to understand what factors should impact your decisions regarding the implementation of these innovative solutions.

  5. Achieving Operational Efficiency In Today’s Fragmented Market
    7/26/2019

    Meeting the goals of today’s industry requires a deeper look at how to continuously achieve maximum utilization and reduce waste without sacrificing quality in the race to be first to market. 

  6. Pharmacokinetic Strategies In CNS Drug Discovery
    7/25/2019

    The failure rate for new drugs targeting important CNS diseases in general have higher failure rates than the other diseases, both preclinically and clinically. Pharmacokinetics of the drug along with the drug delivery mechanisms play an important role in determining the success of new CNS drug because blood-brain barriers (BBB) limit the entry of molecules into the CNS. This paper discusses some successful PK approaches that we have employed in the recent past and may help in CNS targeted drug discovery and development efforts.

  7. In Vivo Models And In Vitro Assays For Human RSV Infection - Pre-Clinical Antibody, Small Molecule And Vaccine Development
    7/25/2019

    Despite over 50 years of research, there remains no licensed vaccine product and disease due to RSV infection remains an unmet medical need. In vitro & in vivo models for RSV vaccine development can provide a critical component in development of anti-RSV antibodies, small molecules and vaccines. Learn how customized and high quality pre-clinical animal models and ex vivo readouts can support your anti-RSV biologics development from concept all the way to IND.

  8. 4 Steps Toward End-To-End Connected Manufacturing
    7/25/2019

    Breaking down the implementation of continuous manufacturing into the following four steps may provide some much-needed guidance as you prepare your network for the future of biomanufacturing.

  9. A Highly Reproducible In Vivo Model For Bleomycin-Induced Lung Fibrosis In Mice To Evaluate Drugs For The Treatment Of IPF
    7/25/2019

    Bleomycin-induced pulmonary fibrosis has been a useful pre-clinical model in several species and is most prevalent in rodent models to evaluate potential prophylactic and therapeutic drugs for IPF. The induction and progression of the disease in rodents is of a short duration, making it a practical model for evaluating test compounds in preclinical research. Major drawbacks for this model have been its mortality rate and inconsistency in the induction of the disease. Access to a large portfolio of in vivo fibrosis models allowed for successful drug testing.

  10. Transient Lentiviral Vector Production In HEK 293T Cells Using The BioFlo 320 Control Station With A BioBLU 5p Single-Use Packed-Bed Vessel
    7/11/2019

    Lentiviral vectors (LVs), which are especially applicable to gene therapy, are promising vector types for the clinical trials of such treatments. Current bottlenecks in the production of LVs are caused mainly by the disadvantages of classical two-dimensional culture forms. Switching to bioreactors can eliminate those disadvantages and offer the benefits of process automation, tight regulation of production conditions, and reduced labor input. This application note describes the first successful experimental setup to cultivate LVs in HEK 293T cells adherently grown on Fibra-Cel® disks in a BioBLU 5p Single-Use Vessel.