Building on the reputation of previous years, Pharmig, the pharmaceutical microbiology association, has delivered an insightful, educational and entertaining annual conference. With a two-day event held at the Nottingham Belfry Hotel on 28-29 November, Pharmig 2018 drew to a close on a high note, stressing that trained professionals are key to production process success.
The event attracted microbiologists from all corners of the UK and Ireland; and a handful of them from further afield including Europe and the USA. From young professionals working at well-known companies and startups to top-rank executives of global pharmaceutical giants and local authorities, everyone in attendance engaged with the wealth of knowledge displayed by the conference speakers and industry insight showcased all along the exhibition floor.
If there is something that is unique to Pharmig is that it has created the opportunity for its members, delegates and guests to share their experiences, challenges and achievements in a professional and friendly setting.
Conference overview
Latest updates and hot topics in microbiology, the tagline of the event, Pharmig 2018 delivered precisely that and beyond. Philip Rose, good manufacturing and distribution (GMDP) inspector at the UK's Medicine & Healthcare Products Regulatory Agency (MHRA) kicked off the conference with a comprehensive review of inspections findings.
From environmental monitoring to contamination control including investigations and the basics, the take-home message underlined the importance of understanding the process and that trained staff play a central role when it comes to compliance.
Picking up on the current trend in the market towards innovative cell and gene therapies (ATMPs), Seb Hodgkin, VP Quality at Cell Medica, presented an overview of the microbiological challenges in making these products. The main issues, he explained, are around sterility assurance and microbiological tests. This area is still in development hence other issues involve adapting the regulatory framework to the emerging technologies or vice-versa.
Presenting via video conference call, Tim Sandle revealed the findings of the Pharmig survey on the use and application if microbiological culture media. The outcome was summarised in eight best practice tips, including recommendations on storage, reading, transportation and tracking.
Tony Mayhall, QP & Quality Consultant at MQA Solutions, delivered a practical overview of hygienic design and bad practice. His presentation covered everything from understanding materials and equipment selection to tips for cleaning and maintenance.
Pharmig Chairman David Keen, Senior Global Microbiology Consultant at Ecolab Lifesciences, closed the first day addressing why people are the inherent flaw in critical operations in aseptic manufacturing. Dissecting the human psychology, Keen suggested that one way to effectively promote behaviour changes is by applying the nudge theory: the concept in behavioural science that proposes positive reinforcement and indirect suggestions.
Cases studies
The spotlight on the second day of the conference was directed to hands-on microbiology. Miriam Guest, Associate Principal Scientist at AstraZeneca, revealed the sterility strategy of the company by discussing a case study for a multi-site product. The analysis involved risk assessment, container selection, shelf life support and shipping. Simply put, process understanding is key and here, she said, microbiologists have a role to play in working in close collaboration with the production team.
Endotoxin detection expert Veronika Wills, Associates of Cape Cod, put the spotlight on the factors playing a part in any bacterial endotoxin test. Most importantly, she outlined that success is down to a well-supported, well-developed and well-performed analysis; yet another hint to training.
Industry veteran Teri C. Soli, an author, microbiology and immunology expert and consultant with industry bodies USP, PDA and ISPE, addressed the audience twice with topics about dealing with water. Understanding biofilm growth in water systems was the focus on his presentation on day one, which laid the foundation of his next-day presentation on what to make of the latest water for injection (WFI) harmonisation across pharmacopoeias in the US, Europe and beyond.
For some time now companies have been able to access cheaper non-distillation technologies to make WFI, most of which favour cool system over the traditional hot steam. Here, Soli suggested, is where the risk of biofilm growth comes to play. Soli recommended that understanding each process and implemented the best validation and inspection routine is the best practice.
Steris' Jim Polarine, Senior Technical Service Manager, brought to the conference case studies to exemplify fungal and bacterial spore excursions in cleanrooms. The main message of his presentation was on proactively preventing contamination. His lecture also provided a comprehensive overview of contamination sources and, most importantly, tips for preventing uninvited guests to the clean production environment.
In a joint presentation, AstraZeneca's Karen Capper and GSK's Paul Newby introduced the Microbiology Modernisation Cross-industry Consortium (MMCC), an initiative that has been in the making since June 2018.
The MMCC aims to catalyse transformational change in microbiology testing by establishing strategic partnerships to enable identification of new technologies and to develop best practices. An evolving group currently formed by pharmaceutical giants, the MMCC is also reaching out to other pharma companies and startups in the emerging cell and gene, and advanced therapy arena.
Online training
Closing the conference, Pharmig chairman described all the possible scenarios for risk assessments that can go wrong. Once again, Keen's address underscored the message delivered by all the speakers: effective training is key.
Known for driving microbiology excellence, Pharmig has created an online training platform and was officially presented to the public at the event. A new educational offering, it has been designed as an e-learning tool to make personal training easy, convenient and quantifiable Driven by high-quality demonstration footage, the Pharmig Training Portal delivers coaching to staff in the pharmaceutical and medical device cleanrooms.
Each training video is followed by detailed multiple-choice questions about the subject of individual modules. Upon completion, each user receives a personalised certificate for the successful completion of the module.
The Pharmig Training Portal is currently providing training on cleaning and disinfection of cleanrooms for both industry and healthcare environments and more details can be found on their website www.pharmig.org.uk
If Pharmig 2018 is anything to go by, businesses that take up the training opportunity now available are one step closer to ensuring their excellence in microbiology.