Expert Insights On Fill/Finish

51. Strategies For Minimizing The Impact Of Bioburden And Sterility Testing On Gene Therapy Batch Yield 1/2/2024

    It is widely recognized that gene therapy manufacturing processes result in low yields. This article outlines strategies for reducing the volumes required for bioburden and sterility testing and, therefore, conserving product for patients while remaining compliant and delivering process information on the microbiological status. 

52. Introduction To The New ASTM E3418, Standard Practice For Calculating Scientifically Justifiable Limits Of Residues For Cleaning Of Pharmaceutical And Medical Device Manufacturing Equipment And For Medical Devices 12/11/2023

    The ASTM E55 Cleaning Team has developed and balloted a new standard practice for calculating safe and scientifically justifiable limits for residues found after cleaning processes. This is the first comprehensive guide to setting limits for use in cleaning validation that includes all types of chemical residues, bioburden residues, endotoxin residues, and visual residues.

53. 6 PEG Alternatives You Should Be Thinking About 11/22/2023

    PEGylation is a common way to minimize off-target effects and general toxicity, but it also poses life-threatening risks because it prolongs the drug's time in the bloodstream. Scientists are exploring these alternatives to combat the risk.

54. Understanding The Importance Of Real-Time Monitoring For Protein Aggregation 10/30/2023

    This article breaks down the advantages of real-time monitoring for protein therapeutics, including how it can accelerate timelines, produce better data, and smooth regulatory compliance.

55. Proposed Best Practices For Cell & Gene Therapy Aseptic Process Simulation 10/25/2023

    Aseptic process simulation (APS) plays a critical role in demonstrating that the processes, equipment, and materials involved in sterile manufacturing work in synergy to maintain sterility. Applying existing APS guidelines to cell and gene therapies/ATMPs can be challenging, so BioPhorum proposes a best practice approach in alignment with regulatory guidance.

56. FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities 10/25/2023

    The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.

57. Preformulation Of Excipients In Biologics Development 9/28/2023

    Most of the instability problems of a drug product come from excipients, in particular, they come from impurities in excipients. Those issues are best cleaned up in the preformulation period to determine excipient compatability.

58. How To Implement Size Exclusion Chromatography And Mitigate HCP Risk 9/13/2023

    Research shows size-exclusion chromatography improves the host cell protein detection capabilities of liquid chromatography-tandem mass spectrometry. This guest article explores the strategy of using both to better understand HCP persistence in the purification process.

59. New ISO 14644-21:2023 Addresses Reducing Sampling Errors With Airborne Particle Counters 9/11/2023

    The new ISO 14644 Part 21 addresses optimizing particle counter accuracy in cleanrooms, focusing on reducing sampling error and particle loss. Discussion includes the use of airborne particle counters, tubing, and isokinetic probes.

60. CGMP Requirements For Automated Facility Monitoring Systems 8/15/2023

    To assess facility control, most organizations use facility monitoring systems to monitor the manufacturing workspaces continuously. Let's take a deeper look at current good manufacturing practice (CGMP) requirements for the design and operation of such automated systems, including a look at total particle counting.