In general, what are some current issues or problems pharm/biopharma companies are dealing with in regards to microbiology testing, analysis and identification?
- Two of the “problem” areas for the QC micro lab concern:
- Data integrity, how to implement the requirement for a secondary read of test media plates and remain compliant
- Meeting the safety testing timelines for the new generation of ATMP (Advanced Therapy Medicinal Products) products with shelf lives less than 3 days. Current incubations of 3-5, 5-7 and 14 days will not meet the requirements for these new drugs. This will drive new testing paradigms.
- Given these new concerns, the QC micro labs now also have the additional problem of trying to decide what on-market RMM technologies can help them adapt and improve their quality release processes in the new age.
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Looking at the latest in technology, can you tell us about some new technologies and/or processes that are available now that you are excited about? Do any of these new technologies have the potential to have a noticeable impact on pharma/biopharma company’s microbiology testing and analyzing operations?
I’m very excited about the new technologies and/or processes that are available now and what is to come. There are 5 available and newly-updated technologies that we believe will progress all Micro
QC methods. These are:
- Endotoxin testing has progressed to at line use of individual test cassettes with results in <15 mins and automation of the routine test in the QC lab to help address data integrity concerns
- Automated media plate reading can now utilize colony count systems that reduce resource requirements and add the benefit of improved compliance to CFR requirements for data integrity and security.
- MALDI-TOF ID; Implementation of MALDI-TOF ID technology facilitates faster and cheaper processing of samples and allows broader testing of EM isolates to give a better picture of the status of the manufacturing facility
- Real-time environmental testing –Through use of recent and innovative technologies to produce real time water and air sample testing.
- Environmental monitoring SW in conjunction with on line analytical systems allows a more responsive quality system for troubleshooting and corrective actions.
In the past few years have regulatory expectations from the FDA and other global agencies resulted in more scrutiny placed on microbiology processes? Do inconsistent or different global regulations place a regulatory strain on pharmaceutical companies?
One of the most significant changes in recent years is the increased agency focus on accurate recording and data integrity in microbiology. This has led to a significant number of citations ranging from warning letters to 483s.
Differences in global perspectives are also a concern for our industry. One example of global differences is in defining the ideal incubation conditions for EM testing. Multiple interpretations of the definitions have led to 3 key concerns: 1) uncertainty within the industry about interpretation of regulatory expectations; 2) differing audit results auditor-auditor; and 3) the inability to harmonize across manufacturing sites.
Various PDA and other working groups are seeking to harmonize regulations, but the interpretation will remain a source of concern until we can gain additional clarity as we work with agency partners.
What advice would you give to a pharmaceutical company struggling with their microbiology processes/applications? Is there list of items you would suggest to these companies to help them?
My top 6 suggestions for focus areas would be:
- Hire sufficient qualified microbiologists. It’s a challenge to find the right people with appropriate backgrounds, especially fungal experts (mycologists) who seem to be in short supply.
- Embrace data integrity with both arms.
- Complete investigations, and react to contamination excursions with a solid root cause analysis.
- Ensure the “Preventative Action” part of a CAPA is implemented effectively.
- Implement automated solutions for routine repetitive tasks. Ideally, this would involve suitable RMM’s to the QC micro lab, which also frees up scarce resources. See #1.
- Continue to align QC Micro with the changing needs of manufacturing. Bring back the “C” in CGMP. Microbiology was not frozen with the invention of the petri dish. We have new tools and capabilities, and should use them.
What do you see as the major industry critical issues over the next five years in regard to microbiology?
- Low numbers of graduating Traditional microbiologists. This will probably follow the issues companies have to find specialists in the field of mycology now.
- Supporting ATMPs, to determine how to safely release sterile products with very short shelf lives of 1-3 days.
- Industry 4.0 and the impact on the lab in general