Biosimilar Manufacturing solution center

  1. Are Biopharma Companies Outsourcing Their Ability To Think? 8/5/2026

    Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.

  2. Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring 7/22/2026

    Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.

  3. What Is Pre-Use, Post-Sterilization Integrity Testing (PUPSIT)? 7/20/2026

    Sterile filter integrity testing helps confirm performance, reduce risk, and support stronger processing controls as global regulatory guidance increasingly emphasizes PUPSIT where feasible.

  4. Filtration: The Overlooked Enabler Of Process Intensification 7/20/2026

    Process intensification depends on more than facility changes. Smarter choices can help improve yield, throughput, and sustainability, turning an often-overlooked step into a meaningful contributor.

  5. Process Intensification And Other Ways To Adapt To Changing Needs 7/20/2026

    As biologics manufacturing evolves, gain insight into why productivity depends on smarter investments, flexible production strategies, and supplier support that can address shifting modalities.

  6. Exploring Takeda's Template For Sustainable Steam Generation 7/17/2026

    Takeda designed a model for delivering steam at 11 bar and up to 184 degrees using natural refrigerant and waste heat at one of its largest production sites.

  7. Transforming Computer System Validation In The Life Sciences Industry 7/10/2026

    Regulators acknowledge how traditional CSV methods fail to meet modern demands for speed and flexibility. The scene is changing in favor of smarter, leaner validation.

  8. Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis 7/8/2026

    Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.

  9. A Sterilizing-Grade Membrane For Efficient Filtration Of Biologics 7/7/2026

    Higher flow rates and a smaller process footprint can create meaningful gains across sterile filtration steps. Explore the performance data and where efficiency improvements may be possible.

  10. An Open-Source Modeling Tool For Suspended Continuous Lyophilization 7/7/2026

    Building on a continuous suspended-vial lyophilization workflow, process developers can model critical variables before doing physical experiments.