Growth Direct Systems for Sterility and Environmental Monitoring -- The Video

By now you have seen or heard the news regarding our 2013 release of the Growth Direct^TM Systems for Environmental Monitoring and Sterility Testing.  We are extremely pleased with the positive responses since we made our official announcement at the PDA Annual Meeting last week. 

We had solid attendance at our impromptu booth presentations during the breaks.  We will be sharing the presentation we delivered on the website in the next few weeks.  Right now I am pleased to announce that we have uploaded the video that ran at our booth onto YouTube.  This video gives a clear presentation of what is coming in 2013 as the Growth Direct^TM Systems for Environmental Monitoring and Sterility.  I will also post this video on the Rapid Library.  The video is about 4 minutes. Happy Viewing!

Exciting News to be Announced at PDA Annual Meeting

The Rapid Micro Biosystems blog has been quiet since last year.  That is about to change.  We have been hard at work and will have some major announcements over the next few weeks.   Expect to see more activity on the Rapid Micro Blog in the upcoming months.  Our experts are eager to share their thoughts on automated rapid detection.  

 

Our next event is the PDA Annual Meeting on April 16th.  If Rapid Microbial Detection is an area of interest for you or part of your job, I highly recommend a visit our booth number 801.  We have some exciting news that we will be sharing for the first time during the show.  If you are looking for our booth, reference the map below.

 

We look forward to seeing you in the next few weeks.

Rapid Micro Detection and Patent Expiration

I was recently reading an article on Bloomberg about the expiration of the Lipitor patent and Pfizer’s new strategy of targeting mini blockbusters in the future.  Some of the numbers were staggering.  According to the article, nearly a fifth of the company’s revenue came from Lipitor, the world’s top selling medicine.  With the product now off patent, the expectation, according to the article, is that sales will now drop by as much as 70% in its first year off of patent. 

Lipitor is an example of how important the patent window is to the pharmaceutical manufacturer, and why the strategies to optimize that time window are so important.  Businesses invest millions in research and development to bring pharmaceuticals to market.  For the time that the drug is patented, the manufacturer has the opportunity to maximize its revenue while the clock ticks.  Delays in production or manufacturing could delay getting the product to consumers and creating revenue.  Given how drastic the drop in market share and price is when a patent expires, the manufacturer must have processes in place to ensure efficiency and quality.

Most pharmaceutical manufacturers have embraced lean and six sigma principals in production for just this reason.  Only now are more and more businesses taking on the idea of lean in the lab environments.

The introduction of lean into the lab environment includes processes and improvements such as just in time ordering for lab supplies, creating workstations at lab benches, and kitting materials for QC tests.  As important as process changes are, automation also plays a role in the lab, much like it does in manufacturing.  Automation allows the QC lab to reduce turn around time on tests and maximize the value of the time of the QC personnel.  Add to this the shortened time to result from rapid microbial detection, and the streamlined lab becomes integral to maximizing the patent window. 

Rapid micro detection sure to be a topic at conferences this fall

The leaves are starting to change here in Boston, and we are getting ready to start the fall and winter conference season. 

The pharmaceutical industry continues to be dynamic, struggling with supply issues as well as adapting to the regulatory changes in healthcare here in the US and abroad.  As we met with companies early this year, they sharee their struggles bringing new drugs to market and maximizing the opportunities those drugs create in revenue and further research and development.  They have expressed their frustrations with the manual processes that still remain in production, specifically in Microbial Quality Control, and are looking for technologies to improve throughput and reduce time to results.

We have a full plate for this conference season.  With events both here in the United States and in Europe, Rapid Micro Biosystems will not be hard to find.  Feel free to visit our events page for more details.

There is a lot happening in across the Pharmaceutical industry.  We expect Rapid Microbial Methods to be a popular topic along with Lean labs and other efficiency programs.  We look forward to the one-on-one conversations and networking opportunities that come with the conference setting. 

We will see you there!

More than Microbial Growth at Rapid MIcro Biosystems

It doesn’t take much web surfing to find articles about the tough employment market. From large to small companies, businesses are either reducing staff or simply not hiring.   There are bright spots; however, and Rapid Micro Biosystems is one of them.

Since the beginning of the year we have almost doubled our headcount.  The additions have been in key customer-focused areas of the Rapid Micro team, including Research and Development and Technical Services.  We see these increases as a means to enhance the Growth Direct™ System and expand service offerings to our customers.  Our expanding team will help us provide exemplary service to our current and future customers.

While it has become far more difficult to find a place in the refrigerator to put my lunch, I’m encouraged that at a time when many businesses are reducing staff, we are increasing our investment in human resources and bringing in top talent.  It has been exciting to meet the new team members and gain a fresh perspective based on their expertise. 

As a result of our influx of new talent, you should expect to see some new contributors to the Rapid Blog in the upcoming months.  Everyone here is energized by the growing acceptance of Rapid Micro Methods and specifically the Growth Direct™ System.  We look forward to an successful second half of 2011.

Mark Severns
Marketing Manager
Rapid Micro Biosystems

Rapid Micro Detection: Quarterly Microbe Spotlight

As I am sure is the same for many of us in the field, my first exposure to general microbiology occurred in college. In one of the first lab sessions for the microbiology course we were instructed to swab a surface and transfer its contents onto a nutrient agar plate. Being curious college students, we sampled everything from lab bench top surfaces, to plant leaves and clothing. I was more interested in what critters were growing on me, so I swabbed my hands.

Several days later as we were checking our plates, I heard one girl say that she should do her laundry more often because of the mold that grew on her plate. Looking at my plate, I had a mixture of golden yellow and white colonies growing. After a battery of phenotypic tests, I identified these colonies as Staphylococcus aureus and Staphylococcus epidermidis, respectively. These bacteria, as I later learned, are just two of the many microorganisms that are part of the natural human skin flora.

Hmmm. Where else have I heard of Staph? Reruns of House, M.D. or Grey’s Anatomy, maybe? Who hasn’t heard of a Staph infection?

S. aureus is not only a regular resident on our skin, but in certain conditions will sneak through open wounds and cause infections, sometimes serious, especially to immuno-compromised individuals.

Not a week goes by that we don’t hear about superbugs.  Staph, or a certain strain of it, are one of these responsible bugs. There is an increase in nosocomial infections worldwide in community and healthcare settings. Formally, this superbug is known as methicillin-resistant Staphylococcus aureus (MRSA) and as its name suggests these strains of S. aureus are resistant to beta-lactam antibiotics, such as penicillin. As a microbiologist, I’m amazed at the ability of these bugs to adapt.  As a human, I’m concerned as it is becoming increasingly difficult to treat Staph-related infections. In a study by Klein et al. (2007), between 1995 and 2005, the number of S. aureus-related hospitalizations increased from 295,000 to 478,000 and the number of MRSA-related hospitalizations doubled from 127,000 to 278,000. Initial symptoms of MRSA infections include bumps and blisters at the site of infection. These later become pus-filled boils, which provide a vehicle for transmission, as contact with the pus can cause infection. If untreated, the infection can further advance to widespread infection and toxic shock syndrome (induced by bacterial toxin secretion).

Should you be swabbing your hands and arms everyday to catch Staph? Nah, in most cases, S. aureus, like many microorganisms, are just part of the natural ecosystem that is the human body. 

The traditional test for S. aureus includes general incubation of around 2-5 days. The Growth Direct^TM System for rapid automated microbial detection visualizes this microbe in 9-12 hours.

Jessica Tse
Research Assistant
Rapid Micro Biosystems

Klein E., Smith D.L., Laxminarayan R. (2007) Hospitalizations and deaths caused by methicillin-resistant Staphylococcus aureus, United States, 1999-2005. Emerg Infect Dis: 13(12): 1840-1846.

Take a Peep at the Safest Food Around

How many organisms do you know that can survive being born into scalding hot temperatures that would fry lesser beings into charcoal?  How many of those can also handle osmolarities that would cause E. coli to shrivel up like a raisin and die?  And how many of those could stand the indignity of being covered in pink sugar glitter and shaped into a quasi-amorphous chicken-esque blob?  I’m not talking about thermophiles.  I’m not talking about spores.  I’m talking about Peeps; those “delicious” (as an objective blogger, I’ll refrain from judgment about the culinary qualities of the subject at hand) marshmallow treats so often seen around this time of the year.

Now you may be thinking, “What on Earth do Peeps have to do with Microbiology?!”  Let me tell you.  With the season of barbecues, picnics and seasonal food poisoning upon us, you may be starting to see the obligate news blurbs about proper food handling and storage popping up here and there across the internet.  As a Microbiologist trained in infectious disease and deeply involved in microbial testing, you won’t see me complaining about educational articles on food safety!  However, with all these rules about internal temperatures of turkey breasts and keeping potato salad on ice, I thought it might be nice to take a minute and appreciate those special foods (I use the term “food” loosely) that require no refrigeration and no cooking, yet still manage to maintain an enviable shelf life of up to two years!

With 7 grams of sugar out of a total weight of 8.4 grams, it’s no wonder that these fluffy chicks can last almost indefinitely.  According to a 1999 research study at Emory University, these mysterious confections are resistant to being dissolved in cold water, hot water, alcohol, acetone, sulfuric acid and sodium hydroxide!  These scientists did determine one weakness in the chemical makeup of Peeps: phenol.  Phenol melted the peeps down to a gooey primordial Peep-stew, leaving only two sad wax Peep eyes staring up from the bottom of the test beaker.  (For more information on this fascinating study, see www.peepresearch.org). 

The season for Easter candy has come and gone, but if you’ve still got a basket sitting around filled with cellophane grass and a few lonely, leftover Peeps, feel free to indulge in a bite. Provided your Easter basket isn’t filled with Phenol (and with scientists, you never really know), those leftover Peeps should still be safe to eat until well into 2013! I’ve had cars that didn’t last that long.

Kate Stefani
Scientist
Rapid Micro Biosystems

Rapid Micro Detection: Quarterly Microbe Spotlight

We decided it would be fun to spotlight a different microbe each quarter for both our microbiologist and non-microbiologist readers; Eric Binder, one of our R&D microbiologists, has “volunteered” to kick us off with a microbe of particular interest.
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I remember, as a child, dropping whatever I was eating at the time on the ground, most likely chips, and saying aloud, “ten second rule”.  This “ten second rule” was generally accepted by my friends and seemed to get longer as we got older.  For instance, I would see a chip on the ground from yesterday, and still eat it, all the while muttering, “ten second rule”; college can be a despite time.  Well, my microbiology degree changed all that. 

I now know as a microbiologist by the time I picked up that chip, a host of microorganisms had already started colonizing that chip. Most of them are harmless; however, a couple could, under the right circumstances, be harmful. Pseudomonas aeruginosa, found in soil, water, skin flora and on most manmade environments, especially hospital equipment, which definitely makes the harmful list.  Avoiding P. aeruginosa is futile. It is all around you in high numbers, especially when you venture outside.  Eating that dropped chip at the family picnic becomes all that more thought provoking. 

Have no fear, not too much at least; P. aeruginosa is an opportunistic pathogen, which targets victims with underlying conditions such as Cystic Fibrosis, extreme burns across most of the body or chronic lung disease.  In healthy individuals, the body’s immune system, a wonder itself, copes with many low level infections.  P. aeruginosa likes liquids, and increased levels of can be found in swimming pools that are not properly treated, leading to acute, chronic or life threatening ear infections

Interestingly, P. aeruginosa produces a characteristic pyocyanin pigment which is blue-green and contributes to distinctive blue-green pus associated with wound infections, commonly observed in burn patients.  In addition, to identifying phenotypes, P. aeruginosa exhibits a host of virulence factors, such as adhesins (adherence to epithelial cells), Polysaccharide capsule (formation of a biofilm), exotoxin A (blocks eukaryotic protein synthesis), elastase (destruction of elastic fiber) and phospholipase C (breaks down lipids).    

P. aeruginosa’s omnipresence and propensity to cause disease is the reason why we monitor it in the pharmaceutical industry.  P. aeruginosa may not cause as many infections world wide as Staphylococcus aureus; however, its presence in pharmaceuticals can be drastic.  For example, the colonization of P. aeruginosa in a person with Cystic Fibrosis will exacerbate the disease.  The chances of a Cystic Fibrosis patient picking up an antibiotic resistant strain in a hospital setting is considerable to begin with; however, to contract an infection through contaminated pharmaceutical products taken for the treatment of the disease would be unthinkable.

The typical test for P. aeruginosa using USP defined incubation times for traditional culture method takes about 24 hours.   The  Growth Direct^TM  System for rapid automated microbial detection visualizes this bug in 9-12 hours. 

Eric Binder
Microbiologist Research Associate
Rapid Micro Biosystems

Sterility and the Micro QC lab – is Zero really Zero?

I was recently speaking to one of my colleagues about an interesting presentation given at the PDA Global Conference on Microbiology in October 2009. The presentation, given by Dr James E Akers, was titled Urban Myths in Pharmaceutical Microbiology – The 0 and 1 myth.  Dr. Akers also wrote a more in-depth article on the subject called, “The Myth of Sterility”. I was theorizing with my colleague about what it would have been like to have been part of the audience during the presentation.  Given the topic, I would have expected facial expressions of the audience to range from bewilderment to frustration to understanding.  It is indeed a complex discussion  that I’m sure, when delivered to a room full of industry minds probably drove a mixed reaction. I know my facial expressions ran the gamut, but I’ll keep my computer monitor the only thing privy to that.  I think the topic of sterility, and proving the absence of anythingis intriguing, and Dr. Akers gave me a lot to chew on.

Defining sterility

The term sterility, I admit, waxes philosophical in nature before entering the battling worlds of quality assurance and microbiological testing. Anyone that goes to a hospital, or watches hospital dramas has a very specific view of what sterile is. We microbiologists though take the general public’s concept to a much deeper level, although with a grain of salt. Akers makes the point that sterility in Pharma quality is the “complete absence of microorganisms”, and by extension, an “absolute” that is seemingly impossible to prove scientifically. How do you prove the presence of nothing, as though this “Nothing” is actually a physically defined state (Although well envisioned in The NeverEnding Story)?  This is where it gets interesting.

Proving “Nothingness” where n approaches infinity

Imagine if I asked you to prove the presence of nothing in the air in the area between your nose the computer screen (If there is no space between the two, it may be time to visit the optometrist.) Take a moment to look cross-eyed at that space. (Not too long or your eyes will get stuck that way). How would you begin to design a test method to absolutely prove that there’s nothing there? How big of a sample would you need? At what sampling rate?

For the mathematicians reading, your n (number of samples) size almost instantly approaches infinity, as there are infinite possibilities for there to be 1 of “something” there over time. As your n increases to infinity, your sampling rate has gone running wildly off into infinity too. As the higher n to sample you create, the rate of sampling said nmust increase to accommodate an ever continuous amount. I hope you brought extra batteries for your air sampler! Such is the paradox introduced when trying to prove sterility (nothingness) in Pharma. Now, a statistician reading this may disagree with me in that there is a statistically feasible volume to sample to prove at X% confidence that the remaining volume is sterile. In the end, this still remains a statistical assumption, not a true claim of sterility. Quite simply, there is just too much space to cover to be sure you’ve covered everything.

Don’t cancel your sterility program yet

So, should we just throw out our air monitoring systems and do away with clean rooms all together? Dr. Akers and I agree; of course not. Pharma quality is looking at finite procedures on concrete products in defined areas, such as media fills for in-process batches in ISO rated clean rooms. However, the caveat still remains that to absolutely prove the presence of zero contaminants in an entire batch of product, whether bacterial, viral, or viable but not culturable, one must test and consume the entire product!  But where’s the business model in that? Nonetheless, the public demands safe products and regulatory and QA must still be able to claim sterility assurance based on a heaping compilation of in-process and environmental monitoring data for that specific batch. What is lost in translation is the philosophical impacts.

The solutions to this conundrum seem limitless, as does the amount of stuff to test in the air-in-front-of-nose model I so eloquently provided earlier. To test more volumes, more of the time, seems the only logical solution, given that an entire societal shift in perspective on sterility and consumer safety is out of the question.  

Can rapid micro methods help?

Dr. Akers and I disagree on the value of rapid methods to sterility.  Hey says, “…rapid microbiology, drawing increasing attention by industry, only provides the same imprecise information about the aseptic process we already have, albeit somewhat sooner.”  I think that rapid micro testing methods provide the best case solution to these issues, save for a cultural awakening to true “sterility”. It’s a very prudent response to deliver information sooner rather than later (assuming the RMM selected is as accurate as the current method). Unfortunately, philosophy must give way to practicalities.  Your manufacturing master scheduler likely won’t accept a 14 day sterility test reported result of: “Might be sterile, but who’s to say really?” for a batch of product that has already moved downstream and into holding.   

Akers goes on in his article to talk about approaches to improving sterility by increased scrutiny in manufacturing personnel, aseptic processing, and reduction of interventions based on sterility test failures. I think these are all excellent ways of passively improving production and lessening a sterility failure event.  But, I think everyone would agree that if a product, clean room area, or raw material is grossly contaminated, it’s better to know today than it is to know tomorrow. And RMM is the way of doing so.

Balancing philosophy with practicality

There’s no doubt that the idea of truly proving sterility is indeed an urban myth, and that to prove the presence of nothing is not the same as proving the presence of something. While you can’t test your way to absolute sterility, it’s frankly impossible both statistically and philosophically, as well as business-ally (yes I made that word up), Pharma has a responsibility to deliver on the expectations of consumers that their food, medicine, or product is safe. We can work on better methods improving aseptic technique but also faster detection at the same time. You be the judge.

Sahil Parikh
Senior Research Assistant, R&D Microbiology
Rapid Micro Biosystems

David Jones to speak about rapid micro methods at two upcoming events

Rapid micro methods are a popular topic during this conference season.  In fact in the next 2 months, our very own Dr. David Jones will be speaking on the subject in two different venues.

David will be speaking as part of a joint webinar with Life Technologies on the value of automated rapid microbial detection with automated microbial identification.  During this one-hour, online webinar, scheduled for 10am Eastern time, David will discuss the Growth Direct™ System in detail, focusing on the value it can bring to organizations struggling with manual microbial quality control processes.  You can register for this event here.

For those of you attending the PDA conference in Berlin, titled, “Pharmaceutical Microbiology/Mycoplasma - Enhancing Quality in Process and Product”, from March 15^th - 16^th, you will have  the opportunity to attend David's presentation on the subject of adaptation of direct rapid methods for environmental monitoring.  The agenda includes several other sessions on microbial quality control.

Make sure to attend one of these two events to understand the impact rapid micro methods can have on your micro QC processes.