Molecular
Epidemiology, Inc.
Global Experts in
Genetic-Based
Microbial Identification
& Differentiation
Microbial Contaminant
Source Tracking
Molecular Epidemiology, Inc.
15300 Bothell Way NE
Lake Forest Park, WA 98155
main phone
fax
email
206-306-8882
206-306-8883
[email protected]
www.molecularepi.com
MOLECULAR EPIDEMIOLOGY,
INC.
About Us
WHO WE ARE
Molecular Epidemiology, Inc. (MEI) is a division of the Institute for Environmental Health,
Inc. (IEH). This center of excellence is one of the world’s largest microbial identification
and genetic-based fingerprinting laboratories. Our team of internationally recognized experts
includes microbiologists, virologists, mycologists, toxicologists, molecular biologists, and
forensic epidemiologists. With over 170 employees and 13 laboratories, MEI provides a full
range of cGMP and ISO-17025 validated analytical and consulting services for the
pharmaceutical, biopharmaceutical, personal care, and food industries.
With our expertise in genetic-based microbial identification, epidemiology, and risk
management, your environmental monitoring program can now accurately differentiate
microbes and pinpoint harborage areas of concern. Through sampling and monitoring,
forensic microbiology, consulting, and statistical process control, our clients can
proactively manage their production environment. We make it possible for you to
accurately monitor, identify, and rectify problems well before they reach a critical state.
OUR COMMITMENT
MEI is committed to providing our clients accurate data to support critical decisions
regarding the manufacturing environment and on product safety, to prevent and minimize
economic losses due to unnecessary quarantine. Our full range of services and technologies
enable our clients to thoroughly understand their environmental microbial populations and
make rapid decisions by definitively identifying the root source when contamination occurs.
In addition, our services meet and exceed the new FDA recommendations for the use of
genetic-based methods for microbial identification in the pharmaceutical industry in a rapid
and cost effective manner.
OUR EXPERTISE
The FDA has recently released new guidance documents for aseptic production of sterile
drugs. Within these documents, they have stressed the importance of environmental
monitoring programs for the pharmaceutical industry. An essential component of an
effective monitoring program is a means to accurately identify and characterize microbial
contamination. Practical, reproducible identification and tracking can only be achieved
through the use of molecular methods, which allow for genetic-based identification.
Our validated, polyphasic approach for microbial identification using traditional methods
and DNA sequencing, linked with sensitive DNA fingerprinting sub-typing techniques, is
the basis for our accurate and definitive epidemiological tracking system. This approach,
coupled to statistical process control, provides our clients with the most accurate means
to monitor and track microbes, where it matters most.
At MEI, we utilize an array of leading edge molecular based methods, combined with
microbiological and immunochemical techniques in order to ensure accurate, rapid
and comprehensive microbial characterization and identification. Although we view
accurate species identification as an essential first step in an effective environmental
monitoring program, the ability to track movement and identify the harborage site of
each sub-type within a given species is critical. Precise sub-typing, accurately defining
the intra-species diversity, is therefore of paramount importance to identify source
contamination and accurately monitor your microbial populations.
Molecular Epidemiology, Inc.
15300 Bothell Way NE
Lake Forest Park, WA 98155
phone 206-306-8882
fax
206-306-8883
email [email protected]
www.molecularepi.com
MOLECULAR EPIDEMIOLOGY,
INC.
Technical Expertise
MICROBIAL IDENTIFICATION
MEI ensures rapid identification of every microbial isolate with 100% accuracy. Our
polyphasic approach ensures rapid identification without compromising accuracy. We
also utilize supportive traditional methods, such as gram stain, colonial morphology, and
phenotypic characterization, along with genetic-based methods, such as ribosomal DNA
sequencing to achieve the highest quality of microbial identification.
GENETIC FINGERPRINTING
Molecular sub-typing at the genotypic level is the only accurate means to discriminate
among members of the same species. At MEI, we apply the most discriminatory DNA
fingerprinting methods such as manual Ribotyping, Micro-Restriction Fingerprinting (MRF),
and Pulsed-Field Gel Electrophoresis (PFGE) to differentiate closely related strains and
track their movement within your production environment. Not only is genotypic level
characterization essential to discriminate among resident versus transient strains in the
harborage areas, it enables precise tracking of microbial movement in your production
environment. DNA fingerprinting methods are the only definitive means to locate sources
of microbial contamination, enabling our clients to make rapid informed decisions that
ensure product quality and minimize unnecessary economic loss.
OTHER SERVICES AVAILABLE
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Statistical analysis and environmental monitoring reports
Consulting services
Customized projects
Customized data reporting
Cataloging and storage of microbial collections
Training workshops in molecular methods in microbiology,
risk assessment, and many additional topics
Molecular Epidemiology, Inc.
15300 Bothell Way NE
Lake Forest Park, WA 98155
phone 206-306-8882
fax
206-306-8883
email [email protected]
www.molecularepi.com
MOLECULAR EPIDEMIOLOGY,
INC.
Special Services and Consulting
DESIGN AND IMPLEMENTATION
ENVIRONMENTAL MONITORING PROGRAMS
We work with our clients to ensure efficient environmental monitoring programs using
our proactive monitoring and data management approaches. Our program designs are
customized for each facility with statistical-based sampling plans, active data analysis,
trend analysis, and the application of statistical process control measurements for each
environment and segment of the process. Active monitoring and data analysis, combined
with our microbial source tracking methods, enables our clients access to the most
advanced environmental monitoring and control programs in the industry.
CUSTOM PROJECTS
We team with clients to design custom projects meeting their requirements while
operating in a cost-effective manner. Our consultants and laboratory services become
an extension of your internal services, providing the highest level of expertise within
a confidential environment. With expertise in Epidemiology, Microbiology, HACCP,
Chemistry, Engineering, validations, and product and environmental contamination,
we supply you with a highly comprehensive and efficient project design. We can bring
the expertise directly to your facility and provide the most accurate analytical methods.
Contact us today to learn more!
MODULAR ONSITE LABORATORIES
When your projects require extensive and timely on site services, MEI can also provide
fully equipped, staffed onsite laboratories, offering independent, third party laboratory
services including environmental monitoring and sterility testing. These onsite
laboratories operate under ISO-17025, cGMP and GLP guidelines. Each site-dedicated
laboratory is capable of operating around the clock to ensure rapid sample analysis
turnaround. Results are entered into your specific data base, analyzed, and trended;
SPC charts are generated, and data is reported. Onsite laboratories can handle any
number of samples or analyses types.
Mobile On Site Laboratory
Molecular Epidemiology, Inc.
15300 Bothell Way NE
Lake Forest Park, WA 98155
phone 206-306-8882
fax
206-306-8883
email [email protected]
www.molecularepi.com
MOLECULAR EPIDEMIOLOGY,
INC.
Ordering Services
MICROBIAL INDENTIFICATION & GENETIC TYPING
At MEI, we offer a range of services for single sample through bulk sample contracts,
as well as for extensive ongoing projects, that employ our dedicated consultants.
Our services are designed to give our clients flexibility for routine testing and consulting,
or for timely assistance in an emergency response.
Services are offered with results available on a Standard: 5 - 7 or 10 - 14 day; or Rush:
same day*, 1, 2, or 3 day basis. Microbial culture storage services are also available.
* Same day services require a pure isolate/culture. To guarantee that results will be available
on the same day, samples must be received by 10 am PST. Every effort is made to meet
client deadlines if samples are not received in a timely manner. Due to the inherent nature
of the technique, genetic typing requires a 2 to 3 day turnaround time.
Services include …
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Processing of primary samples
Microbial identification (polyphasic multiple supportive method approach)
Microbial subtyping and DNA fingerprinting (permitting interstrain differentiation)
Microbial quantification
BioPassport™ (extensive characterization of stock cultures)
Bioburden analysis
Microbial contaminant source tracking: tracking movement of microbial
contaminates to their sources and through the production environment
Maintaining validated genetic sequence and fingerprint databases
Microbial culture storage (cryogenic)
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Please call us at (206) 306-8882 or email at [email protected]
to request service quotations.
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OUR COMMITMENT TO QUALITY
MEI is committed to providing the highest quality data to our clients, and is in full
compliance with cGMPs. In addition, our laboratory is ISO-17025 accredited. From the
moment your samples arrive at our facilities, we ensure complete accountability and
traceability. Our QA/QC program includes the use of procedural blanks, replicates, blind
samples, standards, controls, and calibration checks on a routine basis. Each analysis
and all laboratory methods are validated using proficiency test panels, inter-laboratory
sample exchange, and standard reference materials. Contact us to schedule a visit
or audit of our facilities.
Molecular Epidemiology, Inc.
15300 Bothell Way NE
Lake Forest Park, WA 98155
phone 206-306-8882
fax
206-306-8883
email [email protected]
www.molecularepi.com