Industry Insights

  1. What You Should Expect From A High-Functioning CDMO 5/18/2023

    In part one of a two-part series, the authors detail whether to make or buy and how to work effectively with a CDMO.

  2. Improve Scalability And Manufacturability Of A Cytotoxic ADC

    Learn about the process conditions and protocols that were chosen as optimization targets and the resulting improvements to ADC production and purification that assessing these parameters provided.

  3. Market Tumult And The Need For Creative Funding For Life Sciences 6/29/2022

    Life sciences companies have not been immune to the upheaval in the financial markets, casting a pall over equity financing in the sector. Your company will need to be creative in raising capital. This article also covers M&A, synthetic royalty agreements, convertible debt, and covenants. Will there be a reckoning?

  4. Critical Considerations In Outsourcing Nanotechnology Drugs 3/27/2019

    If the mission statement of nanotechnology is “to perform precise interventions at the cellular or molecular level to improve health and promote quality of life,” then the contract manufacturer might seek a mission statement such as, “to enable novel therapy in a safe, effective way, advancing medical science one medicine at a time.”

  5. Using Simple Spreadsheet DoE To Optimize The Protein Pipeline 1/21/2025

    Let's demystify the design of experiments approach with simple tools for implementing 2-level factorial experiments, including workbooks free to download.

  6. MSCs “Versus” Or MSCs “Via” T Cells For Cell & Gene Therapy? 6/23/2022

    We explore how T cells and MSCs don’t have to compete for program time and resources—but can instead work together quite nicely!

  7. The Relationship Between GMP And CMC - And The Team That Ties It Together 9/16/2020

    While GMP adherence might seem like a prescriptive series of boxes that biopharmaceutical producers are responsible for checking off, there’s a bit more strategy involved as it relates to a company’s overarching CMC (chemistry, manufacturing, and controls) strategy.

  8. How Software-Enabled Manual Visual Inspection Can Boost Your ROI 7/14/2025

    Unlock hidden cost savings in pharma manufacturing. Learn how software-enabled manual visual inspection enhances efficiency, data integrity, and regulatory readiness without full automation's capital expense.

  9. Why Cell Washing Is The Hidden Bottleneck In Gene-Edited Cell Therapy 4/29/2025

    Scaling up life-saving gene-edited cell therapies means tackling production inefficiencies. Overcoming the time-consuming and risky cell washing step is crucial for clinical and commercial success.

  10. Mapping The Biosimilar Regulatory Landscape In The Middle East 12/13/2023

    Countries in the Middle East and North Africa are promising markets for biosimilar drugs, but inconsistent regulations pose a challenge. Here's an overview of regulatory structures across the region.