INSIGHTS ON ENTERPRISE SOLUTIONS

• The Interoperability Challenge In Single-Use

  In this segment from the Bioprocess Online Live event, “Single-Use Harmonization Needs A Tune Up,” our panelists define the main challenge plaguing single-use users: a lack of standards across systems and components. This absence of standardization creates a demand for deep, system-specific expertise that complicates interoperability across the industry and even within an organization. They discuss the many layers of nuance and complexity that make large-scale standardization difficult.

• Supplier Standards And Building Hybrid Single-Use Models

  In this segment from the Bioprocess Online Live event, “Single-Use Harmonization Needs A Tune Up,” the panelists advise taking a unit operations approach to standardization. They also emphasize the growing trend of the plug-and-play hybrid models in single-use.

• How End Users Can Drive Single-Use Harmonization

  Though progress has been made in supplier-created standards, broader harmonization is difficult to balance in a competitive supplier market. In this segment from the Bioprocess Online Live event, “Single-Use Harmonization Needs A Tune Up,” the panelists encourage self-regulation for the industry. This bottom-up approach, where standardization begins with end users, will ultimately put competitive pressure on suppliers.

• Addressing Mismatched Connectors And Overcoming Validation Hurdles

  During the Bioprocess Online Live event, “Single-Use Harmonization Needs A Tune Up,” audience members indicated mismatched connectors and validation challenges as their biggest pain points. In this segment, our panelists respond to the audience and weigh in on how to mitigate these difficulties.

• Taking A Risk-Based Approach To Harmonization

  9/12/2025

  In this segment from the Bioprocess Online Live event, “Single-Use Harmonization Needs A Tune Up,” our panelists a risk-based approach to standardizing SUS. They agree that a flexible strategy requires up-front pre-validation and pre-qualification, but it’s worth the initial investment.

• Planning For Flexibility And Supply Chain Resilience

  9/12/2025

  In this segment from the Bioprocess Online Live event, “Single-Use Harmonization Needs A Tune Up,” our panelists discuss the importance of working with your quality team to plan for flexibility, a lesson the industry learned the hard way during the COVID-19 supply chain disruptions.

• Single-Use Standardization Starts Internally

  9/12/2025

  We've all heard the expression: If you want to change the world, start at home. Single-use standardization is no different. In this segment from the Bioprocess Online Live event, “Single-Use Harmonization Needs A Tune Up,” our panelists Mark Petrich, Ph.D., and Frank Gillam, Ph.D., reflect on their success and struggles standardizing single-use systems within their respective organizations.

• How Single-Use Technologies Are Simplifying Contamination Control

  9/10/2025

  Learn how single-use technologies help reduce contamination risks and support compliance with updated EU GMP Annex 1 guidelines for aseptic processing and sterile drug manufacturing.