Insights On Polish & Viral Filtration

41. GMP-Validated Adventitious Virus Testing By Next Generation Sequencing 6/6/2022

    Gain required knowledge related to the involved regulatory authorities and scientific technologies and disciplines: Next Generation Sequencing (NGS), Bioinformatics and Computer System Validation (CSV).

42. Get USP Equivalent Data 5/18/2022

    Adopting analytical techniques that follow compendial guidelines and meeting their criteria doesn’t have to be difficult, even if you’re using different platforms.

43. A Multifaceted Strategy For Viral Safety In AAV Processes 3/10/2022

    Assurance of viral clearance can be difficult, however, during production of vectors such as adeno-associated viruses (AAV) used for the purpose of gene delivery. The need to define and deploy an appropriate and robust viral clearance strategy can be particularly challenging without an overarching strategy in place.

44. Regulatory Considerations For Alternative Microbial Methods 2/28/2022

    We discuss regulatory expectations for the incorporation of alternative methods to prevent, remove, and detect contaminants focusing on comparability and strategies for easier substitution of current methods.

45. Predicting Viral Clearance In Downstream Process Development 2/8/2022

    Optimize purification steps and determine with confidence whether process steps and parameters are effective before investing resources in regulatory supporting validation studies using live virus.

46. Designing Successful Viral Clearance Studies 12/23/2021

    Review studies that involve scaling down individual process steps, and for each step, spiking virus into the specific process intermediate, performing the process step, and measuring the remaining virus.

47. Scale From Cell Factory Systems To A Bioreactor Without Affecting CQAs 12/20/2021

    The challenge was to identify an effective, replicable, and large-scale LVV manufacturing process to meet the growing manufacturing demand without affecting critical quality attributes.

48. Virus Clearance Conquers mAb Solutions 11/11/2021

    Being able to demonstrate robust viral clearance under a wide range of process conditions provides flexibility for process development and avoids unwelcome surprises during validation.

49. Replacing Column Performance Across All Process Conditions 11/10/2021

    Replacement of reusable AEX columns by single-use solutions has proven to be challenging, mainly due to scalability constraints and sensitivity of current technologies to subsets of the typical process conditions. 

50. Quality by Design (QbD) for Adeno-Associated Virus (AAV) 10/14/2021

    CMC is but one obstacle to gene therapy regulatory approval. Here we review a framework for QbD assessment of AAV products within the Chemistry Manufacturing and Controls documentation.