INSIGHTS ON CRITICAL ENVIRONMENTS

• Tips For Successfully Scaling Your cGMP Manufacturing

  What are the specific obstacles to expanding manufacturing capacity? Cell therapy industry leaders share what to look for in a solutions provider and recommendations for navigating your road ahead.

• Germfree's bioGO® Mobile cGMP Cleanroom Walkthrough

  Watch an in-depth product presentation of a flexible, process-ready Mobile cGMP Cleanroom that is revolutionizes the industry by offering a cutting-edge, flexible solution for aseptic processing needs.

• Water Activity Is A Critical Parameter For Microbial Stability

  Learn about USP <1112> Application of Water Activity Determination to Non-sterile Pharmaceutical Products and USP <922> Water Activity, and why water activity is a critical parameter for microbial stability.

• Global EPCMV Firm And Cleanroom Vendor Deliver cGMP Virotherapy Facility

  A global EPCMV firm worked closely with a cleanroom vendor to deliver a manufacturing facility that meets guidelines for BSL2–Large Scale. Learn about the facility, the companies involved, and more.

• Environmental Monitoring Vs. Good Aseptic Technique

  4/23/2024

  Review the standards and regulations promoting a cohesive environmental program, and explore manual compounding in laminar flow hoods, through to filling lines, in both open and closed systems.

• Single-Use Microbial Impactor On A Filling Line

  3/6/2024

  Discover the advantages of a single-use microbial impactor through a demonstration of its ease of use in an isolator and an explanation of its ability to eliminate false positives.

• Modular Cleanroom Overview

  7/14/2023

  Gain insight into AES' projects and experience in cleanroom design innovation, manufacturing, and construction. In this overview, Avid Bioservices, INCOG BioPharma, Theragent, and Charles River share the value of partnering with AES.

• Design–Build Cleanroom Projects: A Proven Risk Mitigating Methodology

  11/17/2023

  Learn about the rising demand for cleanrooms in the biopharmaceutical industry, factors driving cleanroom design, building in flexibility, the role of critical path assessments, and more.

• Contamination Control Considerations For Cell And Gene Therapy Facilities

  4/17/2023

  Gain a thorough understanding of active HEPA purging pass-throughs along with the numerous benefits associated with their use in cell and gene therapy facilities for material control.