PHARMIG ANNUAL CONFERENCE 2019

PharMIG held their 27th annual conference at the Nottingham Belfry over the 13th & 14th November 2019. In attendance were Andrew Barrow, Thomas Parkhill, Andy Whittard and myself. The conference boasted great attendance by delegates and exhibitors. Lead microbiology experts from across the pharma industry presented a range of interesting topics. Pharmig also introduced an interactive app through Glasgow’s events to encourage event participation and providing aspects such as: • An interactive conference agenda linked to speaker biographies • The ability to download speaker presentations in advance or during sessions • The facility to post questions to the panel prior to the event and during live sessions • Interactive voting and polling • A searchable delegate list with messaging facility • Exhibition floorplan with links to the contributors’ websites • Venue details and travel information • Social Wall to post comments, questions and ideas to all delegates • An option to create a personal profile And more, all leading towards a digitally accessible conference. They also set a passport challenge to the delegates, where they had to engage with exhibitors and receive a sticker with the aim of filling the passport. The added twist was that we, the exhibitors, had to ask a question, which made for a lively interactive atmosphere. And it was nice being able to ask the questions I really wanted. Current activities of the USP Microbiology Expert Committee The presentations were broad across the industry, but all stemmed from a microbiology theme. I sat in on a presentation by Donald C. Singer, Member of the USP General Chapters - Microbiology Expert Committee (USA), providing an update on current activities. For me the most interesting components of his presentation is that they actively obtain feedback to aid with the continuous review of the USP. The document is free and can be downloaded online and any burning questions can be submitted to a liaison, who will get back to you on any USP guidance or interpretation. Another component that stuck out for me was the new Chapter 60 on Burkholderia cepacia, which was general information originally, but now is a part of regulation components. There was trepidation on putting in this specific regulation, but it comes from data on deaths in cystic fibrosis patients and infections obtained from ventilators, tracing back to contaminated water systems that may be related to pharma products. The FDA needed the chapter and it helps inform manufacturers. The biggest consideration for Cherwell Laboratories is if manufacturers will start testing water with the suggested Burholderia Cepacia Selective Media, but this is all based on the customer performing risk assessment and suitability for their process rather than say R2A. Open discussion sessions PharMIG also held open discussions for delegates to ask questions and debate amongst industry colleagues on their own practices, the topics were: Measurement of disinfection residues Environmental Monitoring Microbial Identification Microbiology general Q&A surgery I sat in on the EM open discussion and it was great to get an insight in to the challenges companies face and solutions they put forward. I was interested to know that of the delegates attending this discussion: 50% used two types of media for bacteria and fungi; 20% used one media and incubated at two temperatures (usually starting from low to high) and 30% had one media at one incubation temperature and time. Interestingly very few had qualified or had qualification data on their process. One group was asked why they used their method of one agar and two incubation temperatures, as they had changed in the past year. They explained that they had assessed historical data and performed risk assessment and a comparison study over one year before changing. Having enough validation data to explain the change. Desiccation of agar always rears its head as a challenge, and most found it will depend on exposure to higher air flows. To solve the problem of agar desiccation, some will reduce 4-hour exposure of plates to 2 hours or use deep fill plates. Cherwell can provide a variation on fill volumes to help with desiccation. Second checking of colonies seemed to split the room and remained a continuing discussion, putting the question forward, when should you apply second checking? Standardising the process, whether it be an operator, assisted or automated, was an agreed component to the subject. Contact plate pressure and time was debated and whether to use equipment or not? Acceptable practice was to have a SOP, with training for staff and annual retraining. A novel training method was shared, where a delegate used scales to identify how much pressure an individual was applying to get similar pressures. Lunch allowed for a rush of delegates to fill in their passports and gave an opportunity for conversation and discussion with delegates on our product range from the SAS Pinocchio for compressed gas sampling to potentially manufacturing USP standard BSCA. Microbiological considerations for ATMPs The following presentation, Microbiological Considerations for ATMPs, was given by Robert Smith – Director, Smiro Qualitas Ltd which was interesting, as this area is growing considerably. The areas of consideration are different from the normal pharma manufacturer, as looking at testing your starting materials includes not only what is being introduced to the process but also screening of donor product. The question then is, are you testing for everything or only looking for the absence of certain microorganisms? because the donor will have their own micro flora specific to them and it is classed as a non-sterile product. The presence of antibiotics and ensuring that the final product is antibiotic free. Assessing aseptic processing and sterile technique the same as ATP’s maintaining a sterile environment preventing cross contamination or introduction of unwanted organisms. It all eluded to risk assessment of facility and process and that EM programming is still a vital component of ATMP sterility. We have written as short piece on rapidmicrobiology’s website focusing on how Cherwell can aid in microbial testing of ATMPs/ Gene or Cellular Therapies: https://www.rapidmicrobiology.com/news/managing-microbial-contamination-risk-in-atmps-manufacture. Then came the evening Gala for PharMIG which did not disappoint. We were sat on a table with members from both NHS and industry and when microbiologists have a drink, they liven up considerably, even me. David Keen was a great host, presenting the quiz through the first half of the evening. Our table was competitive and hungry to win. Part of the quiz was a number of dance competitions and Anna from Pfizer has some serious moves! I was thrown on to the dance floor to demonstrate my ‘Kung Fu fighting’ and pretended to pull a hamstring, gaining the team 2 additional points (worth the pretend pain!). Our table was pushing for the win, which unfortunately didn’t happen. The evening consisted of a few more drinks, incriminating video’s and some bad photos of which will NOT be attached to this blog!! The new Annex 1 and its impact on environmental monitoring activities The following morning saw a slow attendance in the exhibitor’s area with some sore heads. There was still great involvement and I attended one further presentation provided by Erin Patton on Annex 1 and its impact on environmental monitoring activities – the changes to the annex 1 can be applied towards non-sterile, but we will see how much it will apply. The majority of the language was assessed from Annex 1 and the top terms provide an insight to the focus of the new draft: • Risk • Qualification • Validation • Environmental • Monitoring • Pyrogen • Trend The annex pushes for more appropriate technologies and regulators do want this to happen and have previously stated this attitude at other conferences and that they will assist with the application of innovations. There was an emphasis on continuous routine monitoring and classification/qualification of facilities and processes, leading to question what is normal in your facility from viable and non-viable particles, aseptic prep simulations and knowledge of normal flora of your facility, even seasonal variation? This eludes to trending your EM data and applying the information, that includes not only counts but the ID of organisms to species level. Raising the questions, where is ID useful in C and D grade facilities and where control may be lost? Utilising the EM results as part of your batch release, ensuring sterility of facility and final product. Erin provided a case study, which was one of Charles River Laboratories’ clients, where the lesson learned was that not only the number of colonies was required, but that ID of organisms was needed. It demonstrated the need to establish a base line flora, so you know organisms of concern not only pathogenic before serious action is needed; in this case a facility shutdown that cost millions. Being able to control all spaces is key. The Annex 1 does not have much on C and D grade areas, but you can go beyond the letter of the law to ensure best practice for EM. PharMIG was eventful and positive, in relation to addressing areas of concern in the industry, including being quite fun as well.

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