Editorial Perspectives On Upstream Bioprocessing

  1. Improving AAV Purity Upstream With PCL Manufacturing 3/21/2024

    The downstream separation of AAV capsids affects end-product purity and has been identified as a key pain point of the industry. Ultragenyx’s Dennis Huang advises starting with higher-quality yields upstream.

  2. Doubling Down On Biopharma's Growing Skills Drought 3/13/2024

    The biopharmaceutical industry is building manufacturing capacity at breakneck speed. According to PhRMA, there are 1,580-and-counting biopharma manufacturing facilities in the U.S. alone. Problem is, we're way short on filling those facilities with skilled labor. NIIMBL wants to change that. Here's how, and a great opportunity for big pharma, biotech sponsors, CDMOs, academics, and more to help.

  3. Turning "White Paper Ideas" Into Biomanufacturing Realities 10/19/2022

    NIIMBL Director Kelvin H. Lee, Ph.D. illustrated the power of consortia and public/private partnerships in advancing next-generation approaches to ATMP manufacturing, and demonstrated how the Institute isn’t just talking — it’s building.

  4. Biomanufacturing Capacity Crunch Part 2: Building Optionality 10/12/2022

    In conference event programming, in the trade press, and in water cooler conversation we’re making too many generalizations—which in turn create misperceptions—about the so-called biopharmaceutical manufacturing “capacity” crunch.

  5. Why It's Computational Biology's Time To Shine 8/17/2022

    Astronomical biologic development costs, contracting capital markets, painfully long timelines, and an increasingly stingy regulatory environment are just a few of the reasons computational biology solutions are moving from the “luxury” column to the “survival” column for biopharmaceutical companies. 

  6. Who Said mAbs Were Easy? 4/27/2022

    Under the leadership of CEO Mondher Mahjoubi, M.D., oncology-focused biotech Innate Pharma is developing therapeutic antibodies that harness the immune system to fight cancer. The company is making strides with some next-gen, complex tri- and tetra-specific antibodies—and Dr. Mahjoubi isn't afraid to face the CMC challenges that come with the job. 

  7. Regenerating The Vasculature With Bioengineered Human Tissue 2/23/2022

    With two phase 3 trials resuting in its bioengineered blood vessels being implanted in some 460 human patients, regenerative medicine pioneer Humacyte is finding its footing in the $150 billion vascular repair, reconstruction, and replacement market. Now it's preparing to reinvent treatment for Type 1 Diabetes.

  8. Vaccine Manufacturing: Chasing COVID's Long Tail 1/31/2022

    A host of biopharma companies continue to pour resources into coronavirus vaccine candidates. Among them, iBio stands out with a unique target region (hint: it’s not a spike protein) and an even more unique manufacturing paradigm (hint: it’s not mRNA). 

  9. Reengineering Biologics Manufacturing And Access With Spirulina 1/24/2022

    The “democratization” of biologics requires cost, time, and resource elimination from cell culture to administration and every step in between. Here’s how one innovative emerging biotech is leveraging one of the world’s oldest and most prolific organisms to that end.

  10. Developability: Making Better Bets On Biologic Winners 10/25/2021

    Developability assessments are objective analyses of a molecule’s therapeutic potential, but their execution is as much art as it is science. AltruBio VP of Technical Development Gene Lee, Ph.D. shares his insight into when, why, and how to go about assessing CMC developability.