Featured Pharma Online Editorial

31. Scale And Sustainability In Single-Use Systems 6/13/2024

    I had the opportunity to cover a lot of ground on considerations for single-use technologies in biopharmaceutical manufacturing with Mark Petrich, Ph.D. when he joined me as a guest expert on the Bioprocess Online Live event Single Use Technologies For Bioprocessing: An Essential Update. Here are some of his insights on single-use scale and lifecycle management.

32. Where's The Case For Generative AI In Biopharmaceutical Manufacturing? 6/12/2024

    The early use cases for AI in the biopharmaceutical industry—at least, the early public use cases—have largely come from R&D, and more specifically, target identification and molecular design. Where are the use cases in biologics manufacturing, supply chain management, QMS, and operations, and what’s holding us back?

33. Beware AI Hallucinations 6/7/2024

    As the use of AI increases and expands to new functional areas within biopharmaceutical companies, leaders must understand the risks and mitigate the impact of hallucinations in AI model outputs.

34. Defining And Overcoming Batch Release Deviations 5/31/2024

    Agencies lack a specific definition for deviations, so it’s up to each company to clearly define what they are, and then build systems to prevent and react to them.

35. EMA Updates Guidance On Inhalation And Nasal Product Quality 5/29/2024

    The EMA has issued a new draft guideline, “Guideline On The Pharmaceutical Quality Of Inhalation And Nasal Medicinal Products.” The public comment period ends Oct. 31.

36. 7 Steps To Accelerate Biopharma Manufacturing Processes 5/21/2024

    Now more than ever, manufacturing capability can make or break success. To navigate the challenges, small biopharma companies must adopt these strategic approaches.

37. A Holistic Approach To Container Closure Integrity 5/20/2024

    Regulations are pushing for an approach to container closure integrity that builds quality into the design and processes rather than testing/inspecting the manufactured item.

38. How To Unlock Efficiency In MES Integrations 5/16/2024

    This article outlines the significant benefits and framework for manufacturing execution system (MES) integration with systems such as enterprise resource planning.

39. Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations 5/6/2024

    Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more.

40. Single Use In Biopharma: Beyond Savings & Sustainability 4/17/2024

    SUT continues to trend in biopharmaceutical applications, driven largely by environmental and economic considerations. But there’s a lot more to the SUT story, including supply chain and standardization advantages. We dove headlong into those issues and more with independent SUT expert Paul Priebe and Krystal Biotech VP of Technical Operations Mark Petrich.