Host Cell Contaminant Testing Market Trends and Key Developments

The efficiency of a pharmaceutical purification process defines drug quality including which specific type of host cell contaminants may remain. Analytical methods and commercial reagents are available to determine these contaminants. Host cell proteins are immunogenic and may alter the efficiency of a drug and affect the patient safety. Host cell proteins contain the major contaminants related to biopharmaceuticals. Protein recovery is required to reduce the content of host cell proteins in the final product. Host cell DNA level is another contaminant in biopharmaceuticals. Such contaminants are undesirable.

If these contaminants are vaccinated into patients, they may cause allergic reaction or transfection of cells. The regulatory authorities have released some guidance documents about the accepted level of impurities. The EU, the WHO and the FDA set a definite level of host cell DNA that is tolerable in biopharmaceutical products. Several methods are present for quantifying the level of host cell DNA in biopharmaceutical products. These are hybridization techniques, the Threshold assay, qPCR, and PicoGreen analysis. The wider applications of these molecular biological methods require high assurance of reliability, accuracy, and comparability of the techniques.

The global host cell contaminant testing market is anticipated to register a significant CAGR over the forecast period. The host cell contaminant testing market is being majorly driven by the determination to fulfill safety and legal requirements among manufacturers is anticipated to propel the demand for host cell contaminant testing and drives the global market of host cell contaminant testing. Increasing patient health concern also enhancing the growth of host cell contaminant testing market over the forecast period.

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The need in industries for detail information on performance characteristics of host cell protein and host cell DNA also boost the demand for host cell contaminant testing. However, the lack of variety of existing technologies and platforms may hamper the growth of host cell contaminant testing market. The slow pace of technological innovations in the development of standardized approaches also restraining the growth of the host cell contaminant testing market. The lack of certified standard methods is a significant challenge to ensure the comparability of measurement which may hinder the growth of the host cell contaminant testing market globally.

Geographically, the host cell contaminant testing market is segmented into five key regions such as North America, Latin America, Europe, Asia Pacific (APAC), and Middle East & Africa (MEA). The North America has become the lucrative market for host cell contaminant testing and is anticipated to emerge as the fastest growing market due to several initiatives like measurement of biotechnology programs that support the United Kingdom’s National Measurement System. APAC region is expected to register a significant growth over a forecast period sustainable development in the biopharmaceutical industry. The Europe is also expected to register a significant growth in the host cell contaminant testing market over a forecast period.

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Some of the players operating in the global host cell contaminant testing market are BioGenes GmbH, Bio-Rad Laboratories, Inc., Cisbio Bioassays, Cygnus Technologies LLC (A Maravai Lifesciences Company), Enzo Life Sciences, Inc., ForteBio (A Pall Company), GE Healthcare Life Sciences, Molecular Devices LLC, ProteinSimple (a Biotech Brand), Thermo Fisher Scientific, Inc.and others.These companies are highly focused and further contributing to the growth of host cell contaminant testing market globally.

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