Applications of Molecular Biology in Enhancing Biopharmaceutical Product Safety

@article{1722824,
      author = {Mohammed Fahad, Bibi Ayesa, Tamanna Akter, Aditta Das, Sayema Afroz Eva},
      title = {Applications of Molecular Biology in Enhancing Biopharmaceutical Product Safety},
      journal = {Iconic Research And Engineering Journals},
      year = {2022},
      volume = {6},
      number = {5},
      pages = {333-342},
      issn = {2456-8880},
      url = {https://www.irejournals.com/formatedpaper/1722824.pdf},
      abstract = {There is a safety risk inherent in the manufacture of biopharmaceuticals from living cell systems that has no direct counterpart in small-molecule production, namely adventitious contaminants and process-related impurities. Controlling and detecting these requires the use of molecular biology. In this paper we look at how such applications can be put to work for the betterment of product safety. Our review is informed by an industry survey on the control of host cell protein impurities as well as the international expert consensus on the use of next-generation sequencing (NGS) to find adventitious viruses. What the analysis reveals are two safety mechanisms of a complementary nature. On one hand there is NGS, which offers an unbiased, sequence-based means of turning up unknown viral contaminants; on the other, a more targeted and quantitative approach to the immunological and molecular control of host cell DNA and protein impurities that are known to come from the process. The case is made here that neither of these can replace the other’s particular function in covering risk, so a thorough assurance of biopharmaceutical safety calls for their joint deployment. The one outstanding obstacle to the full regulatory embrace of NGS is the matter of standardization.},
      keywords = {molecular biology; biopharmaceutical safety; next-generation sequencing; adventitious agents; host cell protein; host cell DNA},
      month = {November},
  }