BIO From The Editor and Guest Columns

1. 9 Key Contributing Factors For Maintaining Sterility Assurance 10/15/2024

   The author continues his article series on sterility assurance by discussing nine key contributing factors for maintaining sterility assurance, such as decontamination, materials, and personnel.

2. 3 AI Breakthroughs Revolutionizing Pharma Tech Ops At Roche 10/11/2024

   Roche has pushed through so-called "pilot purgatory" and rolled out artificial intelligence solutions in the real world. Two of its data leaders describe three case studies.

3. What's In The Leukopak Matters For Cell Therapy Manufacturing 10/11/2024

   Advanced cell-based therapies are impossible without high-quality leukopaks from high-quality donors.

4. Survey Says Downstream Biomanufacturing Bottleneck Is Over 10/11/2024

   BioPlan's 21st annual survey finds that downstream processing capacity constraints are at their lowest reported in years.

5. The Regulatory Affairs Function Is Evolving. Are You Evolving With It? 10/10/2024

   The regulatory affairs function is no longer a "one size fits all" function, the decision to outsource or insource the function is growing more complex, and specific AI tools can help regulatory processes.

6. Computer Systems Validation Pitfalls, Part 1: Methodology Violations 10/9/2024

   When computer systems validation work is not performed according to protocol instructions — by cutting corners on quality outputs with the focus on profit as the main driver — this can result in drug and device companies losing profits and efficiencies.

7. 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.

8. The Latest Strategies For Quantifying AAV Capsid Titer 10/8/2024

   Let's take a look at the most commonly used methodologies, including established and emerging techniques, and evaluate the pros and cons of each.

9. Sterility Assurance: The Fundamentals 10/8/2024

   Sterility assurance is a critical aspect of the production of drugs and medical devices. This article covers the fundamentals, including the key components of an effective sterility assurance program.

10. Discovery vs. Hypothesis-Driven Cell Line Development 10/8/2024

    Susan Sharfstein, Ph.D., explains how discovery-driven research can further our understanding of cellular biology and ultimately inform cell line development.