Expert Insights On Upstream Bioprocessing

  1. 11 Key Contributing Factors For Maintaining Sterility Assurance 1/6/2025

    Containers and closures, depyrogenation, equipment, materials, personnel, and 7 more major factors all contribute to sterility assurance.

  2. ASTM International Pharmaceutical Cleaning Standards: Current Status And Future Direction 1/2/2025

    This article provides an update on the progress of the science-, risk-, and statistics-based ASTM International Cleaning Standards: published standards, work currently underway, and how you can get involved.

  3. How Do We Best Meet Future AAV Production Challenges? 12/20/2024

    In the recent past, viral vector manufacturers feared a capacity crunch. Now, with vastly improved productivity, predicting demand is a challenge.

  4. Cell Culture Trends To Watch In 2025 12/12/2024

    Three upstream processing experts weigh in on advancements from the past year and what they're looking forward to in the year ahead.

  5. 5 Characteristics Of Forward-Thinking Microbiology Labs In 2025 12/6/2024

    Improving microbiology laboratory efficiency is a continuum. Here are five tech-forward trends that will impact cost and efficiency in 2025.

  6. 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?

  7. 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.

  8. 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.

  9. 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.

  10. 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.