Featured Editorial

  1. Implementing AI Solutions In GMP While Managing Risk 8/28/2026

    When using artificial intelligence in GMP settings, risk management extends far beyond  validation. This discussion explores moving AI solutions out of the pilot phase.

  2. Europe's ATMP Opportunity Still Requires Local Navigation 8/27/2026

    European nations offer a welcoming environment for clinical-phase cell and gene therapies. Don't assume the same flexibility carries through to commercialization.

  3. The Unspoken Truth About Cell Therapy Product Understanding 8/27/2026

    Developers often discover important attributes after it's too late to act on them. A well-designed program asks what's needed for commercialization and works backward.

  4. Overcoming Recovery Challenges In AAV Production 8/26/2026

    Siren Biotechnology's SVP of vector development, Nathalie Clément, Ph.D., explains the challenge of purifying AAV capsids and the ways developers are optimizing vector recovery.

  5. Enzyme Activity As A Surrogate Potency Marker In Cell Therapy 8/26/2026

    When measuring cell therapy potency, biochemical assays can provide a rapid alternative to the time- and material-consuming standard of cell-based assays.

  6. Implementing And Optimizing Your eQMS 8/25/2026

    This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained.

  7. Choosing Analytical Technologies At The Right Stage Of Development 8/24/2026

    Take a beat before investing in the latest analytical tools. Capability and sensitivity come at a cost. Depending on your phase, you might not need it just yet.

  8. CDMO Selection For Small Biotech: Amit Jain On Avoiding Costly Transfers 8/20/2026

    Make smarter outsourcing decisions early. Reduce the risk of costly tech transfers, evaluate capacity needs, speed development timelines, and strengthen manufacturing partnerships.

  9. The Complex Anatomy Of An ADC Tech Transfer 8/20/2026

    Unlike traditional biologics tech transfer, antibody-drug conjugates have many more moving parts. Here are some of the unique challenges that require close attention.

  10. Preserving Tacit Knowledge In ADC Tech Transfers 8/19/2026

    ADCs built on proprietary platforms risk losing process-specific knowledge during a tech transfer. See what advice panelists from the Bioprocess Online Live event "Ensuring Successful Technology Transfer In ADC Development" shared with the audience on preserving this implicit knowledge.