INSIGHTS ON REGULATORY COMPLIANCE

• Take Action Faster: Using The Alarm List In TSI FMS Web Client

  Monitoring critical events and maintaining process compliance doesn't have to be a challenge. You can gain real-time visibility and control over your operations with a robust alarm management system.

• Tackling Residual DNA Testing In Biotherapy Manufacturing

  Controlling residual host cell DNA is critical for the safety and efficacy of biotherapeutics. Learn about robust, highly sensitive analytical methods for effective DNA clearance and process control.

• Time To Intensify: Taking mAb Manufacturing To The Next Level

  Explore how process intensification can revolutionize monoclonal antibody manufacturing to boost productivity, cut costs, and enhance sustainability with scalable strategies and real-world results.

• ICH Q9 Revision 1: Enhancing Quality Risk Management

  ICH Q9 Revision 1 advances the framework of Quality Risk Management (QRM) in the pharmaceutical industry, by addressing technological advancements and evolving regulatory expectations.

• Visualizing Airflow With Smoke Studies For Aseptic Manufacturing Excellence

  7/7/2025

  JHS uses smoke studies to visualize airflow in cleanrooms, ensuring aseptic conditions and regulatory compliance for sterile pharmaceutical production, especially on new aseptic filling lines.

• Validation Of A Sterilization Process: Part 3

  9/9/2025

  Explore the full scope of sterilization activities and gain key insights into cycle development and validation using BI and BB methods to ensure product sterility and regulatory compliance.

• Advancing Cell Therapy Manufacturing: Rapid Sterility Testing

  5/7/2024

  The rapid sterility test kit used in the study was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71>.

• Comprehensive Regulatory Support

  8/29/2024

  Review our expertise across a wide range of global markets. Our experience in securing regulatory approvals and navigating market challenges positions us as a trusted partner.

• Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements

  4/8/2025

  Achieving compliance and safety through Disinfectant Efficacy Studies (DES) is about adhering to regulations and committing to high standards of safety and quality of manufacturing operations.