GUEST COLUMNISTS

• A Flexible Mindset For Bridging Between Cell-Based Assay Groups

  Transferring cell-based assays for biologics starts with defining operator and equipment parameters, positive and negative controls, and a sufficient dynamic range.

• Advanced Manufacturing And CDMOs Are Rewriting The CGT Cost Equation

  Without contract manufacturers, small biotechs often don't stand a chance of reaching commercial production scales, let alone global access for their drugs.

• Exploring Outsourcing's Role In CGT Scalability And Affordability

  CDMOs give therapy developers access to state-of-the-art production platforms and expertise without the massive up-front investment required for in-house manufacturing.

• 4 Centralized Comparator Sourcing Models To Fortify Supply Chains

  A team at Novartis developed models to address the often-overlooked challenge of clinical trial comparator sourcing, a weak link that can derail trials.

• Essential Steps For A Successful Analytical Tech Transfer

  Biologics tech transfer means sharing up to 20 assays. Miss a step, and you risk delays, bad data, and products stuck in limbo.

• The Evolving Landscape Of Drug Discovery Services

  Pharma and biotech companies are set to pursue partnerships with drug discovery service providers at an increased rate in the years ahead. And it’s not just small and emerging drug companies; it’s also Big Pharma.

• Preparing For FDA's Expanded Use Of Unannounced Inspections At Foreign Manufacturing Facilities

  The FDA announced on May 6, 2025, that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. Here are key considerations and actions to take in order to be prepared.

• Pharma Enterprise Resource Planning: From Automation To AI-Driven Insights

  Pharmaceutical firms are increasingly turning to enterprise resource planning (ERP) systems to modernize operations. These platforms unify core functions, including supply chain management, manufacturing, and financial planning and analysis.