Senior Scientific Officer, Biologics Section, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Ghaziabad, India

Publications

  • Reviews   
    Current Regulatory and Pharmacopoeial Status of Mycoplasma Testing in Concern with Vaccines Safety for Human Use
    Author(s): Muthusamy Kalaivani*, Priyanka Chaudhary, Anubhuti Goyal and Jai Prakash

    Abstract

    Mycoplasma contamination is well known serious microbial contamination that encountered during the production of biopharmaceutical products produced from cell culture. Contamination to this biopharmaceuticals represents potential risk for the health of patients. To minimize this risk monitoring of mycoplasma contamination is preferred during the manufacturing process in cell culture substrates. The current methods recommended by United States Pharmacopoeia, European Pharmacopoeia, British Pharmacopoeia and Indian Pharmacopoeia for mycoplasma testing of biologics involve cell culture methods and indicator cell culture method. The conventional methods require long time period assays (minimum 28 days) and skill for interpretation of the results which limits the use of these assays. The use of Nucleic Acid Amplification Test (NAT) technique provides advantages over c.. Read More»