Wednesday, August 25, 2010

Upcoming SEQ™ Rapid Molecular Methods Seminar

Applied Biosystems will be hosting another FREE SEQ™ Seminar on September 9, 2010 in Cambridge, Massachusetts. The seminar will provide an overview of rapid molecular methods for pharmaceutical manufacturing with a focus on microbiology and Real-Time PCR based analytics. Applications in industry will be presented by users from both traditional pharmaceutical as well as biopharmaceutical companies, testing labs, and R&D facilities. A summary of the agenda is provided below and you can view the entire program and register for the FREE event by visiting

Rapid Molecular and Microbiological Methods: The Link Between Pharmaceutical Manufacturing and Quality by Design Principles
Chair: Dr. Michael Miller, President, Microbiology Consultants, LLC

Cell Culture Surveillance Panel: Safeguarding Your Cell Culture Processes from Key Bacterial and Viral Contaminants
Rapid sample preparation and sensitive detection of Mycoplasma, MMV and Vesivirus. Applied Biosystems.

In Process Testing for Mycoplasma Contamination: Benefits for Biopharmaceutical Manufacturing
Lia Jeffrey, Pfizer

Sample Prep Automation: Maximizing Your Residual DNA Testing Throughput
Tested workflow using the resDNASEQ™ CHO Residual DNA Quantitation System. Applied Biosystems.

Accurate Identification of Bacterial and Fungal Contamination in Your Product and Environment
Highly accurate identification of bacterial and fungal contaminants in less than 5 hours with the MicroSEQ® Microbial Identification System. Applied Biosystems.

Implementation of the MicroSEQ® Microbial Identification System in a Quality Control Lab
Kenny Chan, Biogen Idec

Panel Discussion – Ask the Experts
Moderated by Chair - Open Q&A with all speakers, subject matter experts and Applied Biosystems representatives.

Optional Sessions
MicroSEQ® Software demo.

Tuesday, August 17, 2010

New article on using RMMs for swab analysis

Dawn McIver, President of Microworks, Inc., has just published a new paper on making a case for rapid methods for environmental monitoring. She states that as rapid microbiological methods evolve, their use to perform environmental monitoring could provide a path of less resistance from a regulatory standpoint. Additionally, many of the technologies that have been developed for product testing may have significant merit for performing environmental monitoring. Dawn provides an overview of a case study to determine if it is feasible to utilize an alternative technology to analyze swab samples. In her study, two different test methodologies were utilized. A link to her full paper may be found on our References Page ( under the Applications section. The full reference is as follows:

2010. McIver, D. Using RMM for Environmental Monitoring. Pharmaceutical Manufacturing. 9(7): 37-38.

Friday, August 13, 2010

Automating the Micro QC Lab. An interview with Steve Delity (Part 2)

Last week, I shared part of my conversation with Steve Delity, President and CEO of Rapid Micro Biosystems, on the benefits of automation in the pharmaceutical microbiology lab. The first topic focused on his take around the value of an automated lab. Next, we talked about the future of the Micro-QC lab.

Michael - You described a number of benefits for automation. In a perfect world, what would an automated Micro-QC lab look like?

Steve –
In a perfect world, automation for the QC Microbiology lab actually involves moving QC activities out of the lab and redeploying functions at or near the manufacturing line. This aligns with PAT (Process Analytical Technology) and lean operations paradigms. As an example, QC microbiologists would quickly review data, recognize the issues and be more proactive…essentially getting the information and turning the data into actions much faster than they have been able to in the past.

I recently spoke with a major pharmaceutical company that painted a vision of what is possible for the QC Microbiology lab. They talked about automated rapid detection as a “Kiosk” function, where the point of collection (sample acquisition) is consolidated with point of sampling (e.g., the central testing lab). Labor is streamlined with seamless integration to their LIMS system. It is a value-added process that frees microbiologists from taking samples and reading plates. By automating these activities we can realize improved reproducibility, a decrease in data entry errors and time spent on investigations.

The collection procedures are not yet automated, but automation exists today for the steps after collection, opening time for the QC microbiologists to work on other activities while the automation handles the repetitive actions of pulling and reading samples, and communicating results to data management systems, such as LIMS for other, non-QC stakeholders. In essence, the QC microbiologist is able to “walk away” after taking the sample, letting automation handle the rest.

Automated sample collection has started to catch on with products like Biovigilant in environmental monitoring; however taking an environmental sample is less complex than the other types of Micro QC sampling. Because microbiology sampling is a different animal than some automated sampling systems for analytical and conventional PAT systems, there is still work to do. The good news is that the success of lean micro lab operations will spark continued automation of microbiology processes. It is only a matter of time.

Wednesday, August 4, 2010

Automate the Micro QC Lab? An interview with Steve Delity (Part 1)

I recently had the opportunity to speak with Steve Delity, President and CEO of Rapid Micro Biosystems, on the benefits of automation in the pharmaceutical microbiology lab. During our conversation, I asked Steve four questions to frame our discussion on this topic. This is the first of four excerpts that I will be presenting in my blog. In Part 1, I asked Steve to give his perspective on the value of an automated lab.

Michael -- I think everyone would agree that micro labs need to move to the future and take advantage of rapid microbiological methods. The benefits associated with faster results are well known. Why do you think that automation of the rapid method is important?

Steve -- The traditional model for pharmaceuticals has been to spend significant time and money to develop a drug, and while the clock counts down on the IP, they drive billions of dollars per year from the protected revenue stream. When the patent expires there is still a nice gentle trail off of revenue. This environment has changed. Today, there is tremendous pressure on the traditional model from all sides, including pricing, competing medicines, payouts, and generics. Over the last decade, big pharma has found religion in terms of lean manufacturing, 6-Sigma and driving efficiencies in manufacturing. Quality Control (QC) lab activities have generally gone un-recognized as a contributor to these efficiency challenges, but that perspective is changing. This is especially true of the microbiology lab where manual methods are slow, error prone, labor intensive and not cost effective. Today we are seeing companies apply lean development and manufacturing principles to the labs. I was recently listening to a webcast where Tom Reynolds of BSM noted that Lean is not just about the elimination of waste but also the elimination of wasteful practices. This is where we find opportunities for automation, and why I think automation of rapid methods is important.

What HPLC brought to the analytical lab can be brought to the micro lab through automated microbiological methods. HPLC replaced manual wet chemistry and multiple process steps, resulting in an improved quality of data management with less error rates and greater reproducibility. Additionally, they are now realizing a single point of data entry automatically from these systems, improved efficiency and enhanced access to data distributed throughout a network. This means greater access to information and more efficient decision making. I see the same opportunities for automation to bring benefits to the micro lab. Pharma can realize faster time to market, reduced manufacturing cycle times and the reduction of a common theme among QC microbiologists: a workload that is tremendous, chaotic, and not all that fun. Automation is about improving the work-life balance, and the micro lab is the next wave of focus. Pharma is starting to understand the benefits of operational improvements in the lab and is being proactive.

More from my conversation with Steve in future posts.