Guest Columns

31. Upskilling Your Quality Team For The AI Revolution In Pharma 4.0 3/21/2025

    While AI systems offer advanced capabilities for data analysis, process optimization, and quality assessments, your quality team must first be proficient in interacting with them.

32. 3 Strategies For mAb Manufacturing: How Do You Choose? 3/19/2025

    As cost and supply come under more scrutiny, there are primarily three scaling strategies for mAb manufacturing that can be leveraged, each with its own set of pros and cons.

33. A Practical Guide To Defining Priority Data In MES 3/17/2025

    Manufacturing execution systems (MES) play a crucial role in pharma/biotech, but MES platforms face the challenge of identifying the critical data that should be prioritized for supporting effective operations.

34. How Is The Market Responding To Brisk HPAPI Demand? 3/17/2025

    The rise of precision medicine like ADCs has created new markets for highly potent API. More suppliers are building out capacity to meet the demand.

35. Do Patient Needs Define Biologic Product Specifications? 3/14/2025

    Enhanced product understanding acknowledges the technology advancements of the last 25 years and substantially more complex drug modalities.

36. Are CDMO Partnerships The Answer To Manufacturing Capacity Issues? 3/13/2025

    The current manufacturing strain is exacerbated by factors such as the intensity of scaling up fill-finish and specialized manufacture of drug delivery devices. How can partnering with a CDMO help?

37. A Snapshot Of What Pfizer's Doing With Teleoperated Robots 3/12/2025

    A robotic arm controlled with a virtual reality headset and input devices could aid in complex interventions where automation isn't practical.

38. Retrofitting Facilities For Modern Bioprocessing And Pharma Production 3/11/2025

    The U.K. National Health Service is developing a former warehouse into a multi-modal aseptic manufacturing hub. The project's production head talks pros, cons, and strategy.

39. MHRA Issues New Regulation On Modular And Point Of Care Manufacture Of ATMPs 3/11/2025

    The U.K.'s MHRA has issued a new regulation to allow for decentralized manufacturing of cell and gene therapies (advanced therapeutic medicinal products), describing modular and point of care manufacturing. It becomes effective July 23, 2025.

40. Intensifying Downstream Processing With Magnetic Separation 3/10/2025

    A technique used widely in other industries like steel production and wastewater treatment has emerged as rising star within bioprocessing over the last 10 to 15 years.