BIO From The Editor and Guest Columns

31. Strengthening Shop-Floor QA From The Ground Up 2/24/2025

    Quality is created where and when manufacturing happens, not later through inspection. This approach integrates the QA function into daily production operations.

32. 9 Reasons Why You Should Consider AI In Analytical Instrument Qualification 2/21/2025

    AI is about to completely change the analytical instrument qualification (AIQ) landscape in the pharma/biopharma and medical device industries.

33. 10 Ways To Speed Up CMC In Early-Stage Drug Product Development 2/21/2025

    The inherent complexity of living cell-based products, vector-based gene therapies, and highly sensitive analytical methods demands robust change management strategies.

34. ADC Manufacturing's Biggest CMC Challenges And Ways To Approach Them 2/19/2025

    Manufacturing ADCs is inherently more complex than other biologic drug products. Let's explore some of the key issues, including aggregation, solubility, and thermal instability.

35. Challenges And Opportunities Of Outsourcing Biopharma Development 2/19/2025

    Oversight, knowledge management, and operational/compliance risk make up the three key challenge classifications to consider when approaching a new outsourcing agreement.

36. Which Of These 6 Outsourcing Models Best Suits Your Program? 2/19/2025

    Outsourcing used to be a cost-cutting exercise. Now drug developers use it to add expertise and manufacturing efficiencies to their production teams.

37. Consumables Are Leading The Cleanroom Market — Here's Why 2/19/2025

    As the industry expands, so, too does demand for PPE. This market analysis looks at the trends in consumables and other cleanroom technology used to make medicine.

38. Comparison Of WFI Production Methods: Multi-Effect Distillation Vs. Vapor Compression 2/18/2025

    The two most common hot water for injection (WFI) generation methods are multi-effect distillation (MED) and vapor compression (VC). There are significant differences in terms of operational principles and energy efficiency.

39. Managing Contamination Risks In The Pharmaceutical And Medical Device Industries Using Relational Risk Analysis 2/18/2025

    Of all the risks associated with pharmaceuticals and medical devices, controlling contamination is one of the most important and difficult challenges. Relational risk analysis (ReRA) can help.

40. For Gilead, Sustainability Is More Than A PR Effort 2/14/2025

    Gilead's chief sustainability officer and SVP of operations, Joydeep Ganguly, explains the company's cultural focus on sustainability and how it influences everything from R&D to manufacturing.