Expert Insights On Upstream Bioprocessing

  1. A Risk-Based Approach To Filter Integrity Testing Annex 1 Requirements For Biologics DS 11/8/2024

    How do the principles of filter integrity testing described in EudraLex Annex 1 apply to low bioburden drug substance manufacturing? And how can using a risk-based approach help?

  2. Biopharmaceutical Fermentation Systems' Growing Role In Modern Medicine 11/6/2024

    Bioreactors, culture media, growth factors, and sensors are essential to foster microbial or cell growth in optimal conditions.

  3. How Ring's Single-Capsid Protein Approach Optimizes Viral Delivery 11/5/2024

    Complexity and manufacturability have an inverse relationship. Ring’s platform seeks to simplify highly complex gene therapy production by making the most of biology.

  4. How Elixirgen Manufactures Hematopoietic Stem Cells At The Bedside 10/9/2024

    The company uses a mobile manufacturing system to produce autologous stem cell therapy for patients with dyskeratosis congenita and other telomere biology disorders.

  5. Advanced, Cost-Saving Techniques Improving Cell Therapy Production 9/30/2024

    Low throughput and intense resource demand limit patient access to cell therapies. Automation and in vivo manufacturing are poised to lower those barriers.

  6. This Digital Twin Approach Aims To Optimize ATMP Production 9/25/2024

    Manufacturing therapeutic cells includes labor-intensive processes. These researchers are developing a way to increase yields through cost-effective expansion protocols.

  7. Upping Flow Of Advanced Technologies Into Commercial Biomanufacturing 9/12/2024

    A set of tools NASA developed assessing new, rapidly developed and deployed technology could help biopharmas adopt advanced tech post-commercialization.

  8. Wish SUS Cost Less? Survey Says Your Peers Do, Too 9/6/2024

    BioPlan Associates 21st Annual Report found biopharma companies want lower cost single-use system options over any other new product development area.

  9. Capacity, AI Driving Single-use Bioprocess Probe And Sensor Uptake 8/30/2024

    Disposable probes and sensors offer advantages over their reusable counterparts, especially as industry moves toward flexible, scalable production models.

  10. Luxturna Maker Spark Therapeutics' Flexible Platform Approach 8/28/2024

    The company proved the concept by bringing to market its AAV-based gene therapy for an inherited form of vision loss.