Industry Insights

  1. Pathway Towards Regulatory Approval: Chemistry, Challenges Behind AOCs 9/3/2025

    Explore the fundamental science behind antibody-oligonucleotide conjugates (AOCs), including oligonucleotide synthesis, bioconjugation strategies, and the challenges that arise from their properties.

  2. ADC Executive Roundtable — Perfecting The Payload And Navigating The Regulatory Landscape 7/28/2023

    In a roundtable Q&A, three ADC company executives, Philipp Spycher of Araris, Dan O'Connor of Ambrx, and Radek Špíšek of SOTIO Biotech, dig into the latest developments in drug-antibody ratios. They also discuss the challenges they face when working with regulators for this complex yet promising modality.

  3. Leveraging 505(b)(2): Real-World Evidence Rescues Program 8/8/2022

    Discover how a biotech company that couldn't afford the time and expense of conducting studies recommended by another consultant got assistance for FDA approval.

  4. Weighing The Potential Of Humira Biosimilars In The U.S. — Expected Winners And Losers 10/6/2020

    This is the second article in a two-part series exploring the anticipated competitive landscape for Humira (adalimumab) biosimilars following their U.S. launch in 2023. In this part, we evaluate the potential for individual adalimumab biosimilar products, comparing and contrasting the agents based on a number of important factors, including order of market entry, company resources and reputation, and product characteristics.

  5. 6 Common Root Cause Analysis Mistakes 2/7/2025

    Discover six common mistakes in root cause analysis (RCA), emphasizing thorough investigation, data collection, team involvement, and follow-up to ensure effective problem resolution in manufacturing.

  6. Pacesetters Are Product Innovators Who Embrace Digital Process Enhancement 12/12/2023

    The Josh Bersin Company recently underwent research examining pharma/biotech “pacesetters” in the field. We caught up with Jordan Schmitting, senior research analyst at The Josh Bersin Company, to discuss the trends illuminated by the research.

  7. Top 5 Things to Know for Successful Pichia Fermentation 8/8/2023

    How can your organization optimize the fermentation of pichia pastoris through advances hardware capabilities?

  8. Moving To Multi-Column Chromatography: A Beginner's Guide 2/21/2023

    This step-by-step guide can help you simplify and de-risk batch chromatography with recommendations for generating supporting experimental data, creating and optimizing a MCC process, and more.

  9. Microbial Manufacturing Platform For Non-Platform Proteins 9/26/2024

    Discover how CASPON® Technology can revolutionize your recombinant protein manufacturing processes and enhance efficiency.

  10. Customer Spotlight: Queen Mary University Of London's Centre For Predictive In Vitro Models 5/10/2024

    Discover the future of in vitro modeling at the Queen Mary+Emulate Organs-on-Chips Centre and unlock new possibilities in the field of predictive medicine.