Expert Insights On Fill/Finish

51. Transitioning From Monoclonal Antibody To AAV Separation Science 3/16/2023

    Separation scientists jumping from mAbs to AAV inherently have advantages, but familiarity can also present roadblocks. Here are a few tips on leveraging past experience with mAbs when developing AAV gene therapy products.

52. After Decades Of Biomanufacturing Workforce Development, What's Next? 2/1/2023

    We have seen exponential growth of the biotech industry in recent decades. Companies have struggled to find qualified workers. To close that workforce gap, we need to leverage the lessons from successful biomanufacturing training programs and consider new approaches.

53. Considerations For Microbial Enumeration Methods When Working With CDMOs 1/23/2023

    In microbial enumeration testing, the product-specific interferences are addressed during method development. The execution can vary between laboratories. This article examines general considerations, membrane filtration, and the pour plate method.

54. EMA's Revised GMP Annex 1 Addresses Common Global Challenges For Sterile Products 1/18/2023

    The new EMA GMP Annex 1, “Manufacture of Sterile Medicinal Products," is in line with other international regulations, e.g., ICH and PIC/S. FDA involvement in its writing is a clear indication that the contents will be the FDA position in general terms. Fortunately, the annex contains many checklists to help you assess and remedy your systems.

55. Considerations For Sterility Test Methods When Working With CDMOs 1/13/2023

    Confirmation of microbial quality of drug products manufactured by CDMOs is a key component of product release. It is important to ensure that laboratory-specific method suitability testing is performed to ensure appropriate recovery of the presence of potential contaminants.

56. CDMOs And Contamination Control Strategy: The Span Of Oversight In EU GMP Annex 1 Compliance 12/21/2022

    While the concept of contamination control is not new, the EU's revised GMP Annex 1 requires a formally documented strategy specific to a facility. Under the new set of requirements, the “span of oversight” has shifted, and CDMOs are finding their sterility assurance programs in a position that will require a new level of transparency with sponsors.

57. Cleanroom Gowning Programs Compliant With EU GMP Annex 1 12/15/2022

    Part 1 of this article series provided an overview of cleanroom gowning per the revised EU GMP Annex 1. This article focuses on establishing an aseptic personnel gowning program compliant with the Annex.

58. 4 Key Takeaways For Combination Products As We Move Into 2023 12/13/2022

    The AFDO/RAPS Combination Product Summit brought together industry leaders along with representatives of the FDA's Office of Combination Products. Of the four key takeaways covered in this article, one of them is an update on upcoming FDA guidances on this segment of the industry.

59. Help! The Particle Count Is Overwhelming Us! 12/12/2022

    Contamination issues can challenge any facility, especially legacy facilities and those with intense operational demands, financial pressure. Let's look at some of the most common particle origins and some solutions.  

60. Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview 12/1/2022

    This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.