INSIGHTS ON REGULATORY COMPLIANCE

• Little Patients, Big Challenges: Developing Pediatric Formulations

  Explore the development of high-quality, child-friendly oral formulations, as well as learn about new testing requirements for impurities and innovative approaches to creating age-appropriate medications.

• Shaping The Future Of Process Intensification With Digital Solutions

  Discover how automation, analytics, and AI are driving smarter process intensification and enabling a shift toward connected, continuous manufacturing.

• ISO Cleanroom Standards

  Explore how ISO 14644 and EU GMP Annex 1 shape cleanroom standards, with a focus on particle control, system accuracy, and the surprising impact of tubing length limitations.

• How Intelligent Automation Transforms CQV Workflows

  Discover how intelligent automation is revolutionizing CQV in life sciences to eliminate manual bottlenecks, accelerate timelines, and enhance compliance in an era of increasing regulatory scrutiny.

• A 5-Step Guide To Achieving Your Biosimilar Milestones On Time

  3/24/2025

  As the biologic patent cliff looms, biosimilar developers must strategically plot their approach to development and manufacturing to secure a corner of their market and reach their target patients.

• Accelerate Innovation With Compliant Software Solutions

  9/2/2025

  Accelerate your innovation with software solutions that are designed to streamline operations, reduce costs, and speed time-to-market while ensuring compliance and data integrity.

• Compressed Gas Contamination: Guidelines For Control In Aseptic Manufacturing

  10/18/2024

  Explore key guidelines for preserving the purity and quality of compressed gas, with an emphasis on contaminants, monitoring, and preventive maintenance practices.

• Managing Complex Data In Process Development And CMC

  11/12/2025

  Learn how automated platforms streamline data capture, integration, and analysis—enabling better decisions, improved consistency, and faster workflows across CMC and process development.

• 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>.