Wednesday, June 30, 2010

PDA 2011 Annual Meeting Call for Papers/Abstracts

The 2011 PDA Annual Meeting Program Planning Committee is inviting you to submit a scientific abstract for presentation at this conference. The theme of the 2011 meeting is Harnessing the Power of Knowledge to Drive World Class Science and Technology.
 This is a great opportunity to present your rapid micro method case studies on validation and implementation! Abstracts must be noncommercial, describe developments, strategies or work and significantly contribute to the body of knowledge relating to pharmaceutical manufacturing, process knowledge, quality management and technology. Abstracts must be received by the PDA ( by July 30, 2010 for consideration.

Just Released: Rapid Micro Method Presentations at the PDA 5th Annual Global Conference on Pharmaceutical Microbiology

The PDA has just released the proposed agenda for their 5th Annual Global Conference on Pharmaceutical Microbiology. The conference will be held in Washington, DC on October 25-28, 2010. Below you will find an overview of sessions that will focus on rapid microbiological methods.

Monday, October 25, 2010

Monday Poster Session

Validation of Ruggedness and Robustness of the Automated RMM BacT/ALERT Dual-T Sterility Testing System per USP 1223 / EP 5.1.6 / PDA TR 33. Carolyn Beres, Scientist, BioMerieux, Inc

Milliflex Quantum: A Fluorescence-based Platform for the Rapid Detection of Contaminants in Filterable Products. Wayne Miller, Regional Marketing Manager, Millipore

Tuesday, October 26, 2010

Session B3 – New Technologies 1

Validation of the Bactiflow ALS for Sterility Testing of an Emulsion Product. Michele Brown, Associate Scientist, Alcon Laboratories (Invited)

Using a Novel qPCR Platform To Accelerate Pharmaceutical Microbiology Testing. Amelia G. Trait-Kamradt, Pfizer (Invited)

Implementation of a Rapid Endotoxin Detection System in a Manufacturing Environment. Geert Verdonk, PhD, Senior Research Scientist, Merck Sharp & Dohme Oss

Session B4 - New Technologies 2

MALDI-TOF for the Identification of Environmental Isolates. Sara Polson, Staff Scientist, R&D Department, Accugenix, Inc.

Evaluation of the Millipore Milliflex Quantum Rapid Detection System: An Internal Study of a Novel Rapid Method for Microbial Detection in Traditional Membrane Filtration Bioburden Assays. Kevin Luongo, QC Scientist II, Specialty/Biotechnology, Pfizer Inc.

Celsis Advance and Limit of Detection. Kathleen Alford, Senior Scientist, Alcon Laboratories (Invited)

Tuesday Poster Session

In Process Bioreactor Monitoring Implementing and Validation of Novel Rapid Methods for the Detection of Bacteria and Mycoplasma in Mamallian Cell Cultures. Wayne Miller, Regional Marketing Manager, Millipore

MALDI-TOF for the Identification of Environmental Isolates. Melissa Ruch, Sales Support Leader, Accugenix, Inc.

Wednesday, October 27, 2010

Session P6 - Global Regulatory Perspective on RMM

Speakers from the FDA, TGA and PMDA are invited.

Session P7 – Compendial Challenges with RMM

Open discussion session on the role of the compendia in facilitating the implementation of these alternate technologies.

Thursday, October 28, 2010

The PDA Training and Research Institute (PDA TRI) will host a new course on rapid micro methods that will complement the topics presented at this conference:

Rapid Microbiological Methods: Overview of Technologies, Validation Strategies, Regulatory Opportunities and Return on Investment. Michael J. Miller, Ph.D., President, Microbiology Consultants, LLC.

New microbial ID technology based on light scattering

A new RMM player is about to make its entrance into the microbial identification field. Micro Identification Technologies, Inc. (MIT) and OSI Optoelectronics (OSIO), will manufacture a new microbial rapid identification system, the MIT 1000. The MIT 1000 is a laser-based, microbial rapid identification system capable of identifying 23 different species of pathogenic bacteria just minutes after culturing. The device uses the principles of light scattering to discriminate various bacteria cells that are suspended in filtered water. Incident laser light both reflects off the bacteria’s outer surface and penetrates the body of the bacterium, the light interacts with any structural features and eventually emerges from inside the cell. These light patterns are unique for each species and thereby create a signature that is captured and stored in a computer data base. The MIT 1000 features 35 photo detectors that surround the sample vial and collect light scattering intensities that are generated when a cell intersects the laser beam. Identification occurs when 10-50 organisms are analyzed, and typically takes less than 10 minutes. This is an interesting technology worth following.

Agar agar in my dessert

I recently had dinner at an Asian fusion restaurant in the Research Triangle Park area called "An." My guests and I enjoyed a special tasting menu of their most popular dishes paired with a different cold sake. To my surprise, memories of Fanny Angelina Hesse came to mind when I read the menu and glanced at the description of my dessert. It was called "The Paradise." Here is a description: coconut ice cream served in a young coconut, topped with candied corn, tropical fruit, and Agar Agar. I had spent the day discussing rapid micro methods and how the industry must move away from 19th Century agar-based methods and embrace 21st Century technologies. I just never imagined I would be eating my own words!