Mycoplasma contamination in biopharmaceutical manufacturing remains a critical, yet controllable, risk to product quality, supply reliability and patient safety. Parker has developed a series of technical whitepapers that together provide a comprehensive view of how to characterize, control and prevent mycoplasma in cell culture media and related processes.
WHITE PAPER 1
Validating a Mycoplasma Retention Test to ANSI/PDA 03-2021- Optimizing Conditions for Test Organism Growth
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This whitepaper focuses on the test method itself. It details Parker’s work to confirm and optimize the growth conditions for Acholeplasma laidlawii specified in ANSI/PDA 05 2021, ensuring consistent organism concentration, size and monodispersity. The study also highlights the critical role of Diene’s stain and microscopy in accurate enumeration, providing a robust framework for reliable mycoplasma retention testing of 0.1 µm filters.
WHITE PAPER 2
Demonstrating a Filter's Mycoplasma Retention Efficiency Using ANSI/PDA 05-2021
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Building on the foundation of paper 1, this paper applies the validated procedure to evaluate Parker's PROPOR MR Mycoplasma retention filter. It demonstrates the excellent Mycoplasma retention performance, compares the performance to alternative prefilter configurations, and shows how tighter structures can enhance log reduction value (LRV) and throughput without compromising key flow characteristics. Reporting in-line with ANSI 05-2021 gives manufacturers clear, standardized performance data to support filter selection and risk assessments.
WHITE PAPER 3
Rapid Product Development of high Capacity Mycoplasma Filters to Meet Customer Large Media Batch Requirements
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This paper translates validated retention performance into scalable capacity. It presents a collaborative case study in which Parker rapidly developed a high area PROPOR MR variant to support an increase in media batch size from 18,000 L to 30,000 L, within strict constraints on hardware, materials and processing time. By optimizing pleat design and the inbuilt prefiltration layer, Parker enabled higher throughput and robust sterilization performance, all while minimizing re-validation burden.
WHITE PAPER 4
Preventing Mycoplasma Contamination - A holistic Approach to the Prevention of Mycoplasma Contamination in Bioprocessing
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The final whitepaper steps back to the broader contamination control strategy. It outlines a layered, risk based approach combining supplier and cell bank controls, quarantine and testing, aseptic practices, validated filtration barriers such as PROPOR MR, and modern detection methods including qPCR. The paper emphasizes the value of process automation and sensing (e.g. Parker SciLog platforms) to maintain a filtration process within validated limits, support compliance, and reduce operational risk.
Together, these four whitepapers provide an integrated perspective: from standardized test method validation, through filter retention and capacity optimization, to plant wide risk mitigation strategies. They are intended to support biopharmaceutical manufacturers in designing and operating robust, compliant mycoplasma control programs that protect both production and patients.
