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Adventitious agent detection methods in bio-pharmaceutical applications with a focus on viruses, bacteria, and
Caitlin Morris1, Yong Suk Lee1, Seongkyu Yoon2
1Pharmaceutical Sciences, University of Massachusetts Lowell, Lowell, MA 01854, USA.
Abstract:
Adventitious agents present significant complications to biopharmaceutical manufacturing. Adventitious agents include numerous lifeforms such as bacteria, fungi, viruses, mycoplasma, and others that are inadvertently introduced into biological systems. They present significant problems to the stability of cell cultures and the sterility of manufacturing products. In this review, detection methods for bacteria, viruses, and mycoplasma are comprehensively addressed. Detection methods for viruses include traditional culture-based methods, electron microscopy studies, in vitro molecular and antibody assays, sequencing methods (massive parallel or next generation sequencing), and degenerate PCR (polymerase chain reaction). Bacteria, on the other hand, can be detected with culture-based approaches, PCR, and biosensor-based methods. Mycoplasma can be detected via PCR (including specific kits), microbiological culture methods, and enzyme-linked immunosorbent assays (ELISA). This review highlights the advantages and weaknesses of current detection methods while exploring potential avenues for further development and improvement of novel detection methods. Additionally, a brief evaluation of the transition of these methods into the gene therapy production realm with a focus on viral titer monitoring will be presented.
Insights
This review details methods for detecting adventitious agents like bacteria, viruses, and mycoplasma in biopharmaceutical manufacturing. It evaluates current techniques and explores future improvements for ensuring product safety and sterility.
Area of Science:
- Biopharmaceutical Manufacturing
- Microbiology
- Molecular Biology
Background:
- Adventitious agents (bacteria, viruses, mycoplasma) pose significant risks to biopharmaceutical production.
- Contamination can compromise cell culture stability and product sterility.
- Effective detection is crucial for maintaining product quality and patient safety.
Purpose of the Study:
- To comprehensively review current detection methods for bacteria, viruses, and mycoplasma.
- To analyze the advantages and limitations of existing detection technologies.
- To explore future directions for developing novel detection strategies.
Main Methods:
- Review of established and emerging detection techniques.
- Analysis of methods including culture-based assays, microscopy, PCR, sequencing, biosensors, and ELISA.
- Evaluation of applicability in gene therapy production, focusing on viral titer monitoring.
Main Results:
- Viruses detected via culture, electron microscopy, molecular assays, sequencing, and PCR.
- Bacteria identified using culture, PCR, and biosensors.
- Mycoplasma detected by PCR, culture, and ELISA.
- Current methods have distinct strengths and weaknesses.
Conclusions:
- Ongoing development is needed to enhance sensitivity, specificity, and speed of detection methods.
- Adaptation of these methods for gene therapy production, particularly viral quantification, is essential.
- Improved detection strategies will bolster biopharmaceutical safety and manufacturing robustness.
