Opportunities for rapid methods discussions: where the experts are meeting!

This is the fourth paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2012. Over the past few years, a number of professional meetings have focused on strategies and case studies for the validation and application of rapid microbiological methods (RMM). If you were able to attend one of these meetings, you probably found it encouraging and worthwhile listening to and speaking with end-users, regulators and vendors of the technologies. This year and next are no exception; scheduled conferences and training sessions within Europe and the US will provide the industry with a comprehensive overview and guidance on how to successfully implement RMMs. To give you a feel for what’s in store, this edition of our RMM series will highlight upcoming PDA and ECA RMM sessions. In addition, the last section will provide more information about the overall October 2012 PDA Global Conference on Pharmaceutical Microbiology, of which a number of RMM presentations will be delivered.

European Compliance Academy (ECA) Annual RMM Conference (December 2012)

This two-day conference offers you a unique opportunity to evaluate the new developments in RMM systems, to extend the current experiences in validation, as well as implementation of these systems within the pharmaceutical industry. Attendees will also learn about the expectations of the regulatory authorities and new developments with regard to regulatory requirements.

This year, a number of sessions will involve an initial presentation by the technology vendor followed by end-user case studies on how their RMM was implemented. Speakers will discuss regulatory developments for both the EU and US, the latter discussion focusing on the FDA’s position when using RMMs as an alternative to the compendial sterility test for biologics. Relatively new technologies will be introduced for the detection, enumeration and identification of microorganisms. Additionally, an overview of rapid Mycoplasma techniques will be provided. The following agenda provides a snapshot of the presentation titles and the speakers for this annual event:

Current Developments in Europe. Dr. Sven M. Deutschmann, Roche Diagnostics

• CBER’s Expectations and Experience with for Use of RMM in Product Testing. Dr. Rajesh Gupta, CBER, FDA
• Update on WHO Project for Mollicutes NAT standardisation. Dr. Claudius Michael Nübling, Paul-Ehrlich-Institut
• Universal Strain Identifiers – a unique system of identifiers for Reference Strains. Barbara Gerten, Merck Millipore
• Short Presentation: Validation of a fluorescence based system for rapid microbiological enumeration: Milliflex Quantum.Dr. Mauro Anglana, Merck Millipore
• Validation and implementation of a new rapid microbiological enumeration method. Claudia Wever, Laboratory for pharmaceutical microbiology, Apotheek Haagse Ziekenhuizen
• Raman micro spectroscopy for detection of microorganisms. Dr. Steffen Koch, CellTool, Dr. Oliver Gordon, Novartis
• Molecular strategies for the determination of abundance and physiological status of microbial cells and spores encapsulated in spacecraft polymers. Dr. Christine Moissl- Eichinger, Institute for Microbiology, Regensburg University
• Sterility testing of pharmaceuticals and biologics using rapid microbiological method BACTEC FX & validation. Dr. Annet Ede Jantje van Merode, Bactimm B.V.
• Identification of fungi – Comparison of classic and modern methods. Prof. Dr. h.c. Rob A. Samson, CBS-KNAW Fungal Biodiversity Centre
• Short Presentation description and validation of a new application for the GD system. Anna Mills, Rapid Micro Biosystems
• Mycoplasma PCR Detection: the biggest challenge of Molecular Biology QC. Dr. Emiliano Toso, Merck Serono
• Detection of Mycoplasma with qPCR: Statistical Considerations. Pieta IJzermann- Boos, MSD
• Introduction to Azbil BioVigilant and Instantaneous Microbial Detection. Sergio Gazic, Biovigilant
• Real-Time Environmental Monitoring using Optical Spectroscopy Rapid Methods. Dr. Michael J. Miller, Microbiological Consultants, LLC

The conference will be held on 11 – 12 December 2012 at the Holiday Inn Munich City Centre. On 13 December, there will be an additional workshop with an emphasis on the use of statistics when validating these new technologies. For the validation of rapid microbiological test methods, several experi – ments must be performed to demonstrate that the new method is capable of detecting and counting organisms in test samples and be at least as effective as the compendial method. To quantify the performance, statistical methods form an indispensable tool. This workshop will provide information on the types of experi ments and the statistical analyses that may be performed to estimate the validation parameters of the new rapid methods. The methods will be illustrated with real cases on the validation of RMMs.

Additional information about the conference, and a link to the meeting brochure, may be found on our featured event page: http://rapidmicromethods.com/events/events_ eca_rmm_2012.html.

PDA Europe 4th Annual Conference on Pharmaceutical Microbiology (February 2013)

On 26 – 27 February 2013, the European PDA (Parenteral Drug Association) will host their yearly microbiology conference, with plenty of discussions on RMMs to go around. Although the agenda is still being finalised, a number of speakers have already confirmed their participation. For example, Gustavo Marco, MHRA, will explore RMM issues and opportunities from a regulatory perspective. I will talk about the current trends in RMM validation, and another speaker will focus on the use of RMMs to release a virus vaccine. In addition to a vendor’s exhibition, RMM suppliers will have an opportunity to provide short presentations on their latest technologies and products. And following the conference, I will present an intensive two-day RMM training program. This comprehensive course is designed to provide an introductory review of currently available rapid microbiological method (RMM) technologies, validation strategies, applications, regulatory expectations, financial justification models and imple – mentation plans. Attendees will be immersed in discussions that will provide a comprehensive roadmap for how to evaluate RMMs and employ them in their own laboratory and manufacturing areas.

The conference and training program will be held at the Berlin Marriott Hotel. Additional information may be found on our conference webpage: http://rapidmicromethods.com/ events/pda_berlin_micro_2013.html and on the RMM training course web page at http://rapidmicromethods.com/events/pda_be rlin_RMM_2013.html. I expect the agenda will be finalised over the next month.

PDA 7th Annual Global Conference on Pharmaceutical Microbiology (October 2012)

The next US-based microbiology meeting of the PDA will be held on 22 – 24 October 2012 in Bethesda, Maryland. In terms of pharmaceutical microbiology, the PDA’s Annual Microbiology conference is arguably the premier global event. If you are a pharmaceutical microbiologist in the lab or on the production floor, are entering the field or have any level of interest in the craft of microbiology associated with the manu – facture, control and testing of drugs, devices and biologics, there is no better venue to attend. This conference is renowned for offering a unique forum for pharmaceutical microbiology experts from both industry and regulatory agencies to introduce best practices and innovations that can improve product and process quality.

The three day event offers opportunities for attendees to receive the most up-todate information on issues surrounding pharmaceutical microbiology and associated technologies through presentations, panel discussions, poster sessions, training courses and product vendor displays, coupled with the opportunity to network with leading scientists and engineers.

The theme of the 2012 conference is ‘Everyday Microbiology – It’s All About Control’. The theme reflects two of the basic concepts of the Quality by Design approach to pharmaceutical microbiology: control of the microbiological aspects of the manufacturing process and control of the microbiological attributes of the product. These are not merely aspects to focus upon at a moment in time, but are vital to the lifecycle of the product. To reinforce these concepts, the conference agenda will include sessions dedicated to pyrogen control (including endotoxins), combating biofilms, requirements in main – taining sterility of products and services, strategies for maintaining a non-sterile manufacturing environment and, as always, rapid microbiology technologies.

The popular Urban Myths, Future Leaders sessions and USP Updates will also be on the programme. Two new unique sessions this year address education and training of future pharmaceutical microbiologists and offer a hands-on tutorial of how to ‘do the math’ as it relates to applying the appropriate math – ematical principles to the compendial testing methods. In addition, we are working on a number of other sessions that will bring a unique selection of presentations to the conference. Finally, an excellent selection of poster abstracts has been received and will make for compelling viewing during our poster sessions in the Exhibit Area.

On the final day of the conference, we have expanded your opportunity to listen to and interact with the FDA by including a presentation about the Agency’s Office of Compliance perspectives on microbiological control, risk management and modernisation expectations. Our concluding session will incorporate the annual Ask the Regulators roundtable composed of invited Center reviewers, compliance experts and field investigators who will be available to answer your questions and engage in a cross-panel discussion. This is a unique opportunity to interact with a diverse group of microbiological experts who regulate products from the Center for Drug Evaluation and Research, the Center for Biologics Evaluation & Research and the Center for Veterinary Medicine. This session is guaranteed to be a thought-provoking and educational experience.

In addition, the PDA Training and Research Institute will be hosting five courses from 25 – 26 October to complement topics presented at this conference, which includes a one-day overview of rapid microbiological methods and the upcoming revised Technical Report #33.

Podium presentations that will focus on rapid methods include the following:

• Application of Rapid Microbial Detection and Endotoxin Testing in the Quality Control Laboratory. Thuy Bui, QC Microbiology Senior Supervisor, Pfizer, Inc.
• The Technological and Regulatory Challenges of Implementing an Alternative Mycoplasma Assay and a Perspective on Why It’s Worth It. Brandye Michaels, PhD, Principal Scientist, Biotherapeutic Research, Pfizer, Inc.
• Current Activities of the USP General Chapters Microbiology Expert Committee II: Bioburden Control in Nonsterile Compendial Articles and New Chapter Draft and Revisions to <1223> Validation of Alternative Microbiological Methods. Anthony M. Cundell, PhD, Director, Analytical Sciences Microbiology, Merck Research Laboratories and Vice-Chair, USP General Chapters- Microbiology Expert Committee
• Real Time Environmental Moitoring and the Quest for Parametric Release of Aseptically Filled Product. Michael J. Miller, PhD, President, Microbiology Consultants, LLC
• IMD-A Systems for Instantaneous, Data- Rich Detection. Scott Morris, Applications Engineering Manager, BioVigilant
• Real Time Viable Particle Detection: Key Capability and Application Con – siderations. Darrick Niccum, Global Product Manager-Biotechnology, TSI l Application of Real-Time Microbial Monitoring in an Environmental Monitoring Program. Paul Hartigan, Aerosol Product Line Manager, Particle Measuring Systems l Development of a Rapid and Highly Sensitive Detection System for Bacterial Monitoring in Pharmaceutical Manufacturing. Noe Miyashita, Researcher, Technologies and Bio Clean Rooms, Hitachi, Ltd.
• Rapid Microbiology: Nucleic Acid Amplification Applied to Microbiological Quality Control. Claudio Denoya, PhD, Senior Director, R&D Biopharm Group, Pall Corporation

Poster sessions that will focus on rapid methods include the following:

• Determination of Threshold Values for Rapid Microbiological Tests that Use Measurement Units Other than Colony Forming Units. Daniel Eshete, PhD, Staff Scientist, Pall Corporation
• The Microproof® Water Screening Kit: A new GMP-conforming Molecular Biological Tool for the Quantification and Identification of Bacteria, Yeasts and Molds in all Pharmaceutical Waters. Christina Harzman, PhD, Director of Marketing, Biotecon Diagnostics
• Ring Trial for Evaluation of the MycoTOOL Test with Mycosafe Mycoplasma Culture Reference Standards. Markus Klinkicht, Marketing Manager, Roche Diagnostics
• Validation of the EndoSafe PTS for Final Product Endotoxin Testing and the Impact of Color on Assay Performance. Jeffrey W. Weber, PAT Project Manager, Process Analytical Sciences Group, Pfizer, Inc.
• Validation of a Rapid Method for Qualitative Detection of Microbial Contamination in a Suspension Product using an Adenylate Kinase-enhanced Bioluminescence assay. Ron Smith, PhD, Principal Consultant, Wavefront Consulting
• Use of a Real-Time Microbiological Method to Support Failure Mode Effects Analysis (FMEA). Peter Noverini, Field Applications Scientist, Azbil BioVigilant, Inc
• Case Study: Evaluation of Alternative Rapid Microbiological Methods to Support Microbiological Quality in a Pharma – ceutical Manufacturing Environment. Michelle Luebke, Research Scientist, Baxter Healthcare
• Introduction of iFA Plus and iFN Plus Neutralising Media for BacT/ALERT® 3D Systems. Carolyn Beres, Scientist, Clinical and Industry Applications, bioMerieux
• Multiple Applications and Business Impact of a Novel Rapid PCR-Based Bacterial Identification Technology. Hilary Chan, Quality Scientist, Pfizer Specialty Care

The conference and training programs will be held at the Bethesda North Marriott Hotel and Conference Center. Additional information may be found on our conference webpage: http://rapidmicromethods.com/events/pda_mi cro_2012.html.

Summary

There are a number of upcoming rapid method professional meetings geared toward supporting our industry, and those of you who are considering implementing rapid methods or are in the middle of validating new technologies should make every effort to attend at least one of these comprehensive scientific conferences and/or training sessions. This is your opportunity to meet and interact with fellow microbiologists, regulatory repre – sentatives, key product vendors and other global leaders in pharmaceutical microbiology and rapid microbiological methods. I hope to see you there!

About the author 

Dr. Michael J. Miller is an internationally recognised microbiologist and subject matter expert in pharmaceutical microbiology and the design, validation and implementation of rapid micro – biological methods. He is currently the President of Microbiology Consultants, LLC (http://microbiologyconsultants.com). Over the course of approximately 25 years, he has held numerous R&D, manufacturing, quality, and consulting and business development leadership roles at Johnson & Johnson, Eli Lilly and Company, Bausch & Lomb, and Pharmaceutical Systems, Inc. In his current role, Dr. Miller consults with multinational companies in providing technical, quality and regulatory solutions in support of RMMs, sterile and non-sterile pharmaceutical manufacturing, contamination control, isolator technology, validation and microbiological PAT. He also provides comprehensive training for his clients in the areas of rapid method validation and implementation.

Dr. Miller has authored more than 100 technical publications and presentations in the areas of rapid microbiological methods, PAT, ophthalmics, disinfection and sterilisation, is the editor of PDA’s Encyclopaedia of Rapid Microbiological Methods, and is the owner of http://rapidmicromethods.com, a website dedicated to the advancement of rapid methods. He currently serves on the editorial board for European Pharmaceutical Review, is co-chairing the revision of PDA Technical Report #33: Evaluation, Validation and Implementation of New Microbiological Testing Methods, and routinely provides RMM training programs for the industry and professional organisations worldwide.

Dr. Miller holds a PhD in Microbiology and Biochemistry from Georgia State University (GSU), a B.A. in Anthropology and Sociology from Hobart College, and is currently an adjunct professor at GSU. He was appointed the John Henry Hobart Fellow in Residence for Ethics and Social Justice, awarded PDA’s Distinguished Service Award and was named Microbiologist of the Year by the Institute of Validation Technology (IVT).