Guest Columns

51. Is Your Pharma Facility Ready For The Next Public Health Crisis? 7/17/2025

    Preventive measures wane as a sense of security resumes. Follow these tips to protect business continuity in the next global health crisis.

52. A Flexible Mindset For Bridging Between Cell-Based Assay Groups 7/16/2025

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

53. Advanced Manufacturing And CDMOs Are Rewriting The CGT Cost Equation 7/16/2025

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

54. Exploring Outsourcing's Role In CGT Scalability And Affordability 7/16/2025

    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.

55. 4 Centralized Comparator Sourcing Models To Fortify Supply Chains 7/15/2025

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

56. Essential Steps For A Successful Analytical Tech Transfer 7/14/2025

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

57. Preparing For FDA's Expanded Use Of Unannounced Inspections At Foreign Manufacturing Facilities 7/10/2025

    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.

58. Pharma Enterprise Resource Planning: From Automation To AI-Driven Insights 7/10/2025

    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.

59. Managing Extractables And Leachables In HPAPI Manufacturing 7/10/2025

    These contaminants can compromise the quality, stability, and safety of a drug product, and regulatory bodies mandate assessment to protect patients.

60. Unlocking Value In Biopharma Operations: A C-Suite Call To Action 7/9/2025

    Operational readiness will separate the leaders from the laggards, whether you lead a pharma/biotech innovator, CDMO, or a combination of both.