This article is primarily about the Environmental Monitoring (EM) program that should be in place for biological products including bacterial and viral vaccines, although there is also mention of testing of raw materials and finished product as well. Biological products are derived from cells, tissues or microorganisms through cell culture growth/fermentation, extraction of substances of interest, isolation and purification leading to formulation and filling. Products include allergens, antigens, hormones, enzymes, monoclonal antibodies, immune animal sera, fermentation products and bacterial and viral vaccines.¹ Much of the article will apply to environmental monitoring during formulation and filling of aseptic biological products in general. Aseptic processing is principally what is employed to ensure assurance of sterility, because some vaccines are not filterable or cannot be sterilized by heat, gas or radiation.² Axenic products (sterile except for the organism of choice in the vaccine) must use aseptic processing as well as environmental controls/monitoring, in-situ cleaning/sterilization of tanks and other equipment, closed systems where possible and even disposable single use systems.¹ Therefore, there should be close collaboration between biosafety and cGMP systems to assure control of product contamination or cross contamination and to ensure acceptable environmental control levels. This would apply especially where there are live or spore forming organisms for vaccine preparation and especially for growth of organisms at Bio-safety levels 3 and 4 (negative pressure areas). Per World Health Organization (WHO) documents, no other infectious or live materials should be worked with in the same area during establishment of seed lots and cell banks. Consider the use of dedicated facilities for live or attenuated vaccines and different means of inactivation (chemicals, heat, etc.), while still maintaining antigenicity.¹ Click Here For Complete Article Text
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