Microbial colonies have traditionally been observed on agar media. This is sometimes aided with various forms of magnification and often uses an electronic colony-counting pen to mark colonies. As we know, human counting is subject to error, which can be costly and undermine confidence in lab operations, whilst reported values may also contain human errors during transcription. Health authorities may see these issues as signs of data integrity...
Viewing related articles
Microbial Control: Detection of Cutibacterium acnes, a high-risk aerotolerant anaerobe recovered in the biopharmaceutical industry
This peer-reviewed paper outlines the risk of aerotolerant anaerobic bacterial contamination during the manufacture of biologic drug substance and the challenges of detection. It examines the issues that manufacturers may consider regarding anaerobic bioburden testing during mammalian cell culture biologics processing, focusing on the detection of aerotolerant anaerobes. It also contains case studies from multiple biopharmaceutical companies, which detected Cutibacterium acnes (C. acnes), the primary anaerobe of concern.
A survey of the BioPhorum Microbial Control Workstream found that more than half of the participants reported contamination events with C. acnes. This survey reported variability in the ability of the compendial microbial enumeration tests to detect C. acnes, thus presenting a challenge for bulk biologics manufacturers. This paper recommends testing conditions designed to increase the likelihood of detecting aerotolerant anaerobe contaminations.
Cleaning and disinfection are crucial during the drug manufacturing process. However, while these tasks support the control of microbial contamination through preventive and corrective actions, specific compendia methods do not exist – yet cleaning and disinfection is now a regulatory requirement. This is why BioPhorum’s Microbial Control Workstream has published Disinfectant Efficacy: Understanding the Expectations and How to Design Effective...
Microbial control: Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program
May 2020 | Drug Substance
This paper provides general guidance on how to perform disinfectant efficacy validation and implementation. It includes how to ensure the concepts of disinfectant efficacy are understood, how to interpret facility data and use it to demonstrate control awareness for your facilities, and how to leverage the data to reduce redundancies in validation or verification. It also details an efficient way to qualify disinfectants without impacting the quality of the study. The recommended program could be more robust than any individual approach developed in any one site.
As regulators now require thorough validation studies, the paper is not about why you need to do disinfectant efficacy, but how you do it so you can meet that regulatory challenge for study data and will help build a business case for change.
Ensuring the integrity of microbiological test data is fundamental to drug product quality and patient safety. The FDA is particularly focused on the data integrity of microbial tests as these often use manual methods that could be open to error or fraud. At present, the soundness of traditional culture-based microbiological test data is largely determined by factors such as effective sampling, valid testing and the interpretation of results. A...
Microbial control: Risk assessment of traditional culture-based microbiological tests requiring contemporaneous verification
Mar 2020 | Drug Substance
Unlike most analytical chemistry tests relying on validated automatic instrument systems from which the test is automatically performed, data are electronically recorded and archived; traditional microbiological tests are performed manually, and the results are generally obtained by visual examination and transcribed by hand. Ensuring data integrity in microbiological test data is fundamental and significant to drug product quality and patient safety. The soundness of traditional culture-based microbiological test data is largely determined by multiple factors including effective sampling, valid testing and appropriate result reading and interpretation. In this paper, the fundamentals ensuring microbiological test data integrity are discussed and qualitative risk assessment is performed for the traditional culture-based quality control (QC) microbiological tests requiring contemporaneous verification by the second person.
The Microbial Control team is working on a series of related challenges and driving towards a goal to help all member companies have contamination event free environments as soon as possible. Two detailed areas have been moved forward in the last year, low endotoxin recovery and mold monitoring. Both have been subjects of concern for regulators in recent years and so the group has developed science-based harmonized industry protocols that will...
Microbial control: Microbiological control for affinity capture chromatography processing: an industry perspective
May 2018 | Drug Substance
Due to the potential for microbial colonization, affinity capture chromatography requires robust microbiological control. In this paper the BioPhorum Microbial Control team addresses the microbial risks and controls associated with affinity capture chromatography. Further the paper sets out an approach to improve understanding of the risks for bioburden, and manage these risks through effective controls during the chromatography process so that bioburden issues will be reduced.
Microbial control: Mold control and detection in biological drug substance facilities: an industry perspective
Oct 2017 | Drug Substance
Mold impacts every biopharma company and the prevalence of mold events can be costly. This guidance recommends how biological manufacturers can refine their mold control strategy and develop control strategies for new facilities, processes and products. By putting the paper into practise, companies can be assured they are following best practice in isolating mold events, monitoring mold, and will see a reduction in the instances of mold and ultimately save significant drug substance costs.
Microbial control: Microbial monitoring for biological drug substance manufacturing: an industry perspective
May 2015 | Drug Substance
The purpose of this paper is to provide guidance and drive consistency in regards to microbial control for manufacturers of low-bioburden bulk biologics. This paper provides recommendations based on biologics produced using cell cultures such as monoclonal antibody(mAb)-based products and recombinant protein manufacturing process. These recommendations, from the members of the BioPhorum Bioburden Working Group, are intended to assist biopharmaceutical manufacturers develop microbial monitor-ing strategies and product safety assessments. Each manufacturer is unique, therefore, alternative strategies maybe justified and/or qualified.