GUEST COLUMNISTS

• Building Enterprise Resilience From QRM Signals

  Turn enterprise resource management (ERM) from a checklist into a true decision system — so risk informs everyday choices before quality events become supply disruptions, delays, or regulatory exposure.

• Single-Use Standards Are Maturing, But The Process Remains King

  The food industry inspired single-use in biopharma, but the regulatory landscape is far more complex. If you're worried about compliance, this discussion can help.

• Mind The Potent Compounds When Retrofitting Facilities For ADCs

  Antibody-drug conjugate manufacturing introduces significantly more risk to employees. Likewise, facility safety requirements are especially intense.

• New USP Research Shows MAM As Alternative To Conventional Methods

  Results show the multi-attribute method provided superior specificity and detected molecular modifications far better than the status quo.

• Metrics, Not Audits, Should Lead Vendor Accountability

  Episodic vendor audits are better suited for high-risk areas. An oversight system, based on a hierarchy of metrics, provides greater value.

• Ask The Pros — The Latest In Upstream HCP Mitigation

  We asked leading experts how upstream interventions can reshape HCP control. Here’s what they shared. Answers have been edited for clarity.

• 2026 CDMO Forecast: The 7 Shifts Sponsors Need To Prepare For

  2026 is shaping up to be a year in which operational discipline, strategic alignment, and regulatory preparedness will differentiate high-performing sponsors from those facing avoidable delays.