Bioprocess Pharmaceutical Filtration

Can Process Control Impact the Effectiveness of Mycoplasma Filtration?

Mycoplasma contamination events, although infrequent, can have an enormous and immediate negative impact in terms of lost product batches, in addition to longer-term restrictions upon operations during the process of decontaminating effected areas of the facility. This can lead to reduced productivity and delays in products reaching patients.

When Genentech shared their experience with mammalian cell culture bioreactor contaminations by the bacterium Leptospira1, it highlighted the dangers of complacency with regard to novel contaminating organisms which could potentially be pathogenic. Leptospira and Mycoplasma organisms are difficult to detect and have been shown to penetrate 0.1 micron membrane filters. 

According to Bioplan Associates Inc., 130 of the 240 biopharmaceuticals of cultured US and EU marketed biopharmaceuticals are produced using mammalian expression systems of non-human or human origin. While often more slow growing, and arguably less productive than bacterial, fungal or insect expression systems, the great advantage of mammalian cells is they produce more human-like proteins which can have safety and efficacy benefits for patients.

Mammalian cell cultures can be vulnerable to contamination because they are performed over a protracted period of time and slow growth rates reduce competitive pressures against the contaminating species. In addition, mammalian cells typically require more complex media supplements of which some components can be derived from plants and animals and are potential sources of contaminations.

To support biomanufacturers, industry bodies - most notably the Parenteral Drug Association (PDA) - are working on guidelines with suppliers such as Parker domnick hunter on standards for evaluating Mycoplasma control methods. Wishing to dig deeper into the reasons that Mycoplasma contaminations can occur, Parker domnick hunter has drawn on our experience in filtration and combined it with our knowledge of bioprocess control to ask the question “What more can be done to prevent a catastrophic cell culture contamination event?”

We will be presenting our ideas on how filter performance can be impacted by process control in a webinar, Implementing a risk management based approach to the prevention of Mycoplasma contaminations, on November 20th, 2014 at 10am EST/3pm GMT. The webinar will discuss the potential threat of Mycoplasma, current guidance from industry bodies on managing the risk of Mycoplasma contaminations, and technologies that can be applied to prevent contaminations with a particular focus on how process control can increase the effectiveness of Mycoplasma removal filtration. We hope you can join us.

References:

  1. PDA J Pharm Sci Technol. 2012 Nov-Dec;66(6):580-91. doi: 10.5731/pdajpst.2012., Case Study: A Novel Bacterial Contamination in Cell Culture Production--Leptospira licerasiae, Chen J, Bergevin J, Kiss R, Walker G, Battistoni T, Lufburrow P, Lam H, Vinther A.
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