Industry Insights

  1. Improving Therapeutic Protein Efficacy Through Charge Profile Adjustment 9/10/2024

    By adequately measuring charge variants early in development and implementing effective control strategies, developers can mitigate risks and ensure the safety and efficacy of their mAb products.

  2. A Precision Purification Technology For Microbial Biologics 5/14/2026

    A streamlined purification strategy is reshaping how microbial biologics move from expression to manufacturing. Learn how to reduce downstream complexity while preserving native protein integrity.

  3. An Analysis Of MHRA's Latest Annual GMP Inspection Deficiencies Report 1/11/2021

    The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) recently published its GMP deficiencies data for drug product issued during inspections in 2019. This article provides a high-level overview of that data, including trends from the four most recent MHRA reports (2015, 2016, 2018, and 2019), and identifies and evaluates the critical and major deficiencies from 2019. 

  4. 5 Key Considerations To Biopharma Supplier Risk Evaluation 12/28/2021

    How should engineers and supply chain managers evaluate the assurance of supply programs of their current or potential suppliers? We outline five key areas for consideration and risk evaluation factors.

  5. Analytics: A Referee For The Tug-Of-War Between MSC-EVs' Nature And Nurture 2/25/2025

    Like a referee in a contest, advanced analytical methods are essential to mediate the push and pull of different factors influencing therapeutic efficacy.

  6. Validating Candel's BLA-Ready Analytics Profile 4/22/2026

    The adenovirus/prodrug company discusses in-house assay development and the validation work to confirm CQAs like potency and cell line integrity.

  7. Liberating Intelligence: The Industrial AI Orchestration Layer 1/15/2026

    Unlock predictive manufacturing by bridging IT and OT. The Industrial AI Orchestration Layer delivers real-time insights, compliance, and scalability, turning fragmented data into actionable intelligence.

  8. Rethinking Capital Efficiency In Cell Processing 8/7/2025

    In cell processing, rigid, single-function equipment can lead to inefficiencies, wasted space, and scheduling conflicts. A versatile approach can help teams do more with less.

  9. The New Economics Of Cell Therapy Manufacturing 2/24/2026

    Cell therapy’s future hinges not just on scientific progress but on scalable manufacturing. Explore why reliability and productivity now shape viability and how modernizing operations can support growth.

  10. Safely Navigating The Transition From MDD To MDR 7/25/2025

    If devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory compliance is achieved in the most effective way.