Industry Insights

  1. Applying Industry Benchmarks To Dictate Your CDMO Choice 2/23/2023

    Commonly utilized as a market research tool, learn how performance benchmarking is helping to make CDMO selection less arduous.

  2. A New Guide For Promotional Labeling And Advertising Of Biosimilar Products 5/26/2020

    This article will outline the central components of new FDA guidance on promotional labeling and advertising considerations for biological reference and biosimilar products. While such materials are overseen by the FDA, the article also explores an alternative method of challenging claims of misinformation and other forms of unfair competition that may impact the biosimilar space moving forward.

  3. How Reshoring, GLP-1s, And Supply Chain Security Are Transforming CDMOs 1/23/2026

    Explore how reshoring, GLP-1 capacity demands, and integrated U.S.-based manufacturing models are reshaping CDMO partnerships in a rapidly evolving pharmaceutical market.

  4. Selecting Drug Delivery Systems For Higher Doses, Viscosities And Lower Risk 1/18/2022

    Discover how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.

  5. 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter 1/18/2021

    In Part 1 of this two-part article, we evaluated the U.K. Medicines and Healthcare products Regulatory Agency’s GMP inspection data for 2019 and addressed the critical and major deficiencies. In this part, we take the 10 chapters and annexes with the highest numbers of deficiencies and do a deeper dive into the specifics of each.

  6. Design Of Experiments Approach To Enabling Studies For Process Validation

    A recent project applied process improvement methodology to the process validation step that ultimately provided not only an optimized, robust process but also an economic advantage.

  7. Multi-Attribute Method Analysis: Moving Toward Mainstream 11/1/2022

    Employing the Multi-Attribute Method based on liquid chromatography-mass spectrometry analysis represents a critical advancement in evaluating the complexity of biotherapeutic molecules.

  8. Apple Watch Approval Marks Shift In Device Development And Approvals 10/24/2018

    Getting to this point has been a multi-year progression of technological development and regulatory evolution by both the market and government.

  9. Biotech's Plastic Problem Meets Its Match 8/8/2025

    Explore how a partnership with UW–Madison and Genentech developed a breakthrough recycling technology that is poised to reshape single-use bioprocessing sustainability.

  10. Collaboration For Clinical To Commercial Manufacturing Success

    Begin your ADC manufacturing journey by finding a partner who can provide support through every phase of the conjugate life cycle, including process optimization, scale-up, and validation.