Guest Columns

41. 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.

42. 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.

43. 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.

44. 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?

45. 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.

46. 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.

47. Generic Drug Approvals In Canada: Use Of A Foreign-Sourced Reference Product As A Canadian Reference Product 3/10/2025

    Brush up on guidance on how to demonstrate that a foreign-sourced reference drug is acceptable to the Minister of Health as a Canadian reference product for an Abbreviated New Drug Submission and Abbreviated Extraordinary Use New Drug Submission.

48. 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.

49. Trends In FDA FY 2024 Inspection-Based Warning Letters 3/7/2025

    Of the 190 warning letters that the FDA issued to drug and biopharma manufacturers in fiscal year 2024, this article provides a deep dive on trends pertinent to the 111 inspection-based letters. You may be surprised at some of them.

50. AI Performance Management In Biologic And Drug Development 3/7/2025

    Life cycle maintenance is essential in AI-driven drug development. Regulators recommend continuous updates to AI models to monitor and adjust for data pattern changes.