Expert Insights On Fill/Finish

31. Bacterial Endotoxin Testing, Part 1: Overview 7/16/2024

    All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.

32. End-To-End mRNA DS And DP Manufacturing Processes 7/10/2024

    This article demystifies the manufacture of mRNA encapsulated in lipid nanoparticles across unit operations for plasmid linearization, drug substance (DS) manufacture, and drug product (DP) manufacture.

33. The Ins And Outs Of Modern Barrier Systems For Sterile Manufacturing 6/10/2024

    This article looks at key features of restricted access barrier systems and isolators and discusses some of their applications.

34. New Guide Tackles Best Practices For Making Allogeneic Cell Therapies 6/3/2024

    The ISPE sought to accelerate guideline development for allogeneic cell therapy. This discussion digs into some of the bigger themes in its recent guide.

35. 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.

36. Points To Consider For Assessing Lipid Quality For Lipid Nanoparticle Manufacturing 5/29/2024

    Lipid nanoparticles have generated a ton of buzz, but they pose risks that, perhaps, industry and regulators have not taken seriously enough so far.

37. Can ICH Q14 Ease Regulatory Risks Around Impurity And Potency Testing? 5/21/2024

    Variability is inherent to biologics manufacturing. The trick is to catch it quickly and prevent product quality drift. That’s where the new ICH Q14 comes in.

38. 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.

39. Evaluating, Validating, And Implementing NAT-Based Mycoplasma Detection Methods 5/3/2024

    Regulatory authorities advocate using alternative adventitious agent tests, but adoption has been slow. Here’s how to validate an alternative mycoplasma detection assay.

40. A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies 2/21/2024

    Establishing a robust contamination control strategy for advanced therapy medicinal products, also referred to as cellular and gene therapy products, is of utmost importance. We must employ risk assessments and risk-based approaches. In this article, the authors introduce the aseptic risk evaluation model (AREM), which is compliant with the evolving global regulatory landscape and best practices.