Mycoplasma contamination events, although rare, can have an enormous and immediate negative impact on biomanufacturers leading to reduced productivity and delays in products reaching patients.
Parker Bioscience Filtration will be examining how to implement a holistic approach to the prevention of Mycoplasma contamination in an upcoming webinar entitled: The Prevention and Control of Mycoplasma Contamination in Bioprocessing which will take place on January 15, 2019, at 3 p.m. London time/10 a.m. New York time.
Here presenters Guy Matthews, global market development manager, and Dr. Carolyn Heslop, technical support group team leader, answer common questions on the threat posed by Mycoplasma contamination and how this can be tackled by biopharmaceutical manufacturers.
What are the potential consequences of Mycoplasma contamination?
“Short-term consequences for a biopharmaceutical manufacturer can include unplanned downtime and lost batches. This can result in the supply of pharmaceutical products to patients being affected. In the long term, there may be financial consequences through a loss of confidence in the manufacturer and a resulting decline in the company’s stock value.”
— Guy Matthews
Why does Mycoplasma contamination pose such a risk in biopharmaceutical manufacturing processes?
“As Mycoplasma can infect mammalian cell cultures through adhesion and subsequent fusion to cell membranes, this allows them to exploit the conditions and synthesized molecules provided by the host cell. This means that detection and quarantine procedures must also be implemented around cell lines. Mycoplasma can vary in size and shape from 0.2 microns upwards, have no peptidoglycan cell wall and exhibit pleomorphism (the ability to alter size and shape in relation to environmental conditions). This means that they are capable of penetrating sterilizing grade filtration systems.”
— Dr. Carolyn Heslop
What steps should biopharmaceutical manufacturers consider in combatting this threat?
“Start with the basics: employing the standards of Good Laboratory Practice. Considering factors such as the storage and packaging of media, and understanding the nature of the supply chain are all important factors in mitigating the risk of Mycoplasma contamination. Identifying where contamination is likely to originate from and mitigating the risk at the source can prevent problems further on in the process. Gamma irradiation or heat inactivation to eliminate Mycoplasma present on gamma or heat-stable incoming raw materials can be used to guard against contamination. However, not all media components can be heated or subjected to irradiation. Therefore, filtration has a vital role to play in combating contamination during the biopharmaceutical process. Biopharmaceutical manufacturers should consult with their filter suppliers on issues such as filter sizing to ensure that their filtration systems are optimized appropriately."
— Guy Matthews
What kind of filtration system is needed?
“In order to effectively control Mycoplasma, the use of a Mycoplasma retentive 0.1 micron filter – such as Parker's PROPOR MR – is recommended. However, as the filter is twice as tight as a standard 0.2 micron sterilizing grade filter, pressure levels in the process can be a major concern. Filters may not function effectively if the flow is too rapid – for instance when pressure peaks occur.”
— Dr Carolyn Heslop
Is there a solution to this challenge?
“Biopharmaceutical manufacturers could consider implementing an automated single-use system. This ensures that critical process parameters such as pressure levels can be constantly monitored, ensuring the process stays within the validated process limits. An automated single-use system will also remove the possibility of human error – and give manufacturers more control over the process.”
— Guy Matthews
Sign up for our webinar and learn how to mitigate the risk of Mycoplasma contamination
For more information on the advantages of single-use technology in mitigating the risk of Mycoplasma contamination and how to implement a holistic approach to the prevention of Mycoplasma contamination, register for Parker Bioscience Filtration’s forthcoming webinar: The Prevention and Control of Mycoplasma Contamination in Bioprocessing. The webinar will take place on January 15, 2019, at 3 p.m. London time/10 a.m. New York time.
This post was contributed by Guy Matthews, global market development manager, and Dr Carolyn Heslop, technical support group team leader, at Parker Bioscience Filtration, United Kingdom.
Parker Bioscience Filtration specializes in automating and controlling single-use processes. By integrating sensory and automation technology into a process, a biopharmaceutical manufacturer can control the fluid more effectively, ensuring the quality of the final product.