Industry Insights

  1. 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.

  2. Trends And Benefits Of Lean Manufacturing In Pharmaceutical Injectable Facilities 8/4/2025

    The pharmaceutical injectable manufacturing sector is experiencing unprecedented transformation through lean manufacturing adoption. This analysis examines current implementation trends, productivity impacts, and quality integration strategies based on data from leading pharmaceutical organizations.

  3. 2023's Market Outlook For Cell And Gene Therapies 2/14/2023

    This article discusses quantifiable market trends, clinical developments, regulatory landscape analysis, and investment trends for cell and gene therapy companies in 2023.

  4. Building A GMP-Ready Cell Line Development Strategy From Day One 9/11/2026

    Embedding manufacturing and regulatory readiness early streamlines development, reduces delays, and supports successful scale-up.

  5. Advancing Formulation Strategies for Complex Drug Products 4/30/2026

    An event-focused overview examining how formulation development and stability strategies support robust, scalable drug products discussed at the DDF Summit Berlin.

  6. Survey Results Show What Could Finally Make Sustainability Stick 9/8/2023

    Results from BioPlan's "20th Annual Report of Biopharmaceutical Manufacturing and Production" show that lasting sustainability strategies should focus on profitability aspects. That's because, even more than a spirit of stewardship, financial advantages provide a powerful incentive to stick to the plan.

  7. In-house Or Outsource? 3/18/2020

    This paper addresses five considerations that should be carefully explored when pre-clinical and clinical drug development companies make their manufacturing decision. These considerations are control, cost/available capital, time to market, leverage, and business/monetization strategy.

  8. Power Tools Or Power Skills? 12/20/2023

    Power skills extend beyond technical expertise and enable managers to effectively communicate, collaborate, and lead. Find out which skills are proven to be exceptionally valuable for managers.

  9. Rethinking Manufacturing Processes To Identify Green Opportunities

    Reducing the carbon footprint of your pharmaceutical fine chemicals manufacturing process requires a shift from the traditional process development approach. Sustainability requires revolutionary changes.

  10. 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.