Insights On Upstream Manufacturing

  1. Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective

    There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.

  2. Benefits And Challenges Of Driving Modernization In Vaccine Development

    Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.

  3. A Beginner’s Guide To Bioprocess Modes – Batch, Fed-Batch, And Continuous Fermentation

    In this application note, we explain the differences between batch, fed-batch, and continuous fermentation and how these influence culture growth. In our examples we studied E. coli fermentation at bench scale. The principles may also apply to bioprocesses using other microbes or mammalian cells, at both smaller and larger scales.

  4. Controlled, Large-Scale Manufacturing Of hiPSC-Derived Cardiomyocytes In Stirred-Tank Bioreactors

    Effective drug discovery and development relies in large part on the availability of predictive preclinical model systems. Application of human cellular models from tissues which are difficult to access, such as cardiomyocytes and neurons, is still challenging. Researchers from Ncardia® developed a bioprocess for the large-scale manufacturing of cardiomyocytes derived from a variety of healthy and diseased hiPSC lines for implementation into their DiscoverHIT platform.

  5. ICP-MS Analysis Of Multiple Trace Elements In Industrial Cell Lines

    Characterization of trace elements is important for upstream process development and batch quality control. In this poster, Catalent Biologics outlines a strategy using inductively coupled plasma-mass spectrometry (ICP-MS) to conduct trace-level multiple analysis.

  6. Achieving Unique Synergies In Antibody Expression

    Combining Catalent’s GPEx cell line development technology with Berkeley Lights, Inc.’s Beacon platform for clonal cell line selection resulted in stable, higher-expressing clones in a shortened time frame.

  7. Robust Alternative To Cryobags For Large Volume Cryopreservation

    Cryopreservation of small sample volumes is common in many scientific applications. However, there is increasing demand for large-volume cryopreservation, especially in cell and gene therapies, where treatments require large cell numbers. This study demonstrates an optimized cooling protocol for cryopreserving large-volume cryovials in a VIA Freeze Quad controlled-rate freezer, avoiding the need for liquid nitrogen.

  8. Large Volume Cryopreservation – A Liquid Nitrogen Free Proof-Of-Concept Study

    This study demonstrates a cell freezing protocol that uses the LN2-free VIA Freeze Quad controlled-rate freezer for the cryopreservation of up to eight cryobags and up to 560 mL total volume.

  9. The Parameters That Matter In Cryopreservation And Cell Thawing Process Development

    Which parameters really matter for cell therapy process development? G. John Morris, CEO Asymptote, part of GE Healthcare Life Sciences discusses the evidence in this blog post.

  10. CMC Strategies For The Development Of A Bispecific Antibody Platform for Cancer Immunotherapy

    Bispecific antibody development presents many challenges in product expression, bispecific purification, product stability, and scale up of the manufacturing process; therefore, CMC strategies are critical for developing and marketing bispecific drugs.