Below is the list of our upcoming conferences for 2010 and 2011.

If you plan on attending or would like to know more, contact Leslie Maas at 570.586.2411 or leslie.maas@calvertlabs.com. We would love to schedule a time to meet with you!
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Safety Pharmacology Society Meeting 2010
Boston, MA
September 20-23, 2010
Booth #203
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ACT 31st Annual Meeting
Baltimore Marriott Waterfront Hotel
Baltimore, MD
November 7 – 10, 2010
(Booth # will be posted soon)

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AAPS 2010
New Orleans Morial Convention Center, New Orleans, LA
November 14–18, 2010
Booth #821
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ToxExpo 2011
Walter E. Washington Convention Center
1207 9th Street Northwest Washington, DC
March 7–9, 2011
Booth #301
(Calvert will also be sponsoring the Golf Putting Station on Tuesday evening during the ToxExpo 50th Anniversary Celebration)

In 1999, the U.S. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) recommended the mouse LLNA as a valid test method to assess the skin sensitization potential of most types of substances.  Regulatory agencies around the world now commonly accept the LLNA.

It has several advantages over the traditional guinea pig assays (the Buehler assay and the Guinea Pig Maximization Test).  First of all, the LLNA is run in mice which are lower on the phylogenetic ladder than guinea pigs and it uses fewer animals, which fulfill two of the animal welfare requirements (refinement and reduction).  Also adjuvant is not required which reduces the pain and distress for the animals, colored products do not mask the results, and the results are quantitative and are obtained within a week.

In 2007 concern was raised about the use of the LLNA with formulated products (mixtures) which had not been considered in the original evaluation.  ICCVAM convened an independent scientific peer review panel to review the use of the LLNA with mixtures and aqueous solution.  In June of 2009 the panel made the recommendation that the LLNA was suitable for use with these types of materials.

The use of radioactivity in some cases can be an issue.  Therefore, the peer review panel also evaluated 3 non-radioactive modified versions of the LLNA.  Two of the assays, the LLNA:DA and the LLNA:BrdU-ELISA were found to be acceptable with certain limitations.  The committee, however, concluded that the third assay, the LLNA:BrdU-FC, needed further evaluation since the results that were presented were only from one lab.  An interlaboratory validation study is needed.

The committee also evaluated a reduced local lymph node assay (rLLNA).  When appropriate, this method can reduce the number of animals used for each test by 40% compared to the traditional LLNA.  The rLLNA was found acceptable for use in hazard identification of skin-sensitizing materials if dose-response information is not needed.  It can also be used as an initial screen to determine the sensitizing potential of a material before conducting the traditional LLNA.  The only difference between the rLLNA and the traditional LLNA is that for the rLLNA only 1 dose of the test material is used.  The concentration should be the highest achievable concentration that does not cause overt systemic toxicity and/or excessive local irritation.  When used as a screen, if the results are negative, no further testing is required.  However, if the results are positive, the traditional LLNA should be conducted.

Calvert Laboratories has over 15 years of experience with the LLNA.  Our standard protocol follows the ICCVAM recommendation and all regulatory guidelines.  Contact Dr. Joan M. Chapdelaine at joan.chapdelaine@calvertlabs.com to discuss your next sensitization study.

We’ve grown accustomed to receiving real-time information. Many of us get breaking news stories instantaneously on our phones.

When we need to know our bank balances and which items have cleared or want to transfer funds–we go to our phones or computers for instantaneous information.

We expect access to information.  We expect effective, timely communication. That’s our normal lives today. And at Calvert Labs, we’re working to make it normal in our communication with you.

Coming March 2010—We are in the process of building a secure, near real-time, info-on-demand area of our website which will provide each client private access to info such as study schedules, study progression notifications, lab certifications, inspection information, and more. In addition, clients will be able to download an iPhone application which provides 24/7, secure, mobile access to their data.

What if it’s 11PM—or the weekend—and you need access to the most recent information on your study?  What are you going to do?  With most companies you will wait until the next business day. If you are a client of Calvert, you’re going log in and find that information. You will be able to download the App from the Apple store for free, use our secure name/password protection to access your account, and view your current study information whenever/where ever it’s convenient for you. Your App’s icon will indicate that there have been updates to your study so you will know that new information is available.

These new additions will further enable us to improve communication and become more responsive to our clients’ needs. Contact us today to learn how your life can be better at Calvert.

Our new data collection system will provide our clients with a greater degree of flexibility in study design, defined measurements, and ultimately in reporting. Other benefits include: statistical analysis integrated into data reports, greater variety of report formats, and a reduction in time needed to complete study reports.

The Xybion Pristima™ system provides our clients with a greater degree of flexibility in study design, defined measurements, and ultimately in reporting.  Xybion provides continuous product and service improvements as well as excellent technical support.  There is also an independent User Group run by the client community which meets yearly to discuss the system, present issues and make recommendations about the the system to Xybion.  Quality Assurance auditors from the User Group perform independent audits of Xybion and the system for FDA GLP and Part 11 compliance and report their findings to Xybion.

There are several features which can improve overall study quality. Among the features:

• More efficient data entry such as manual entry with minimal screen changes, keystrokes and mouse clicks.
• Interfaced data collection for body weights, feeder weights, and any other type of data that could be recorded via an interfaced device such as a balance, barcode reader or clinical pathology instruments.
• Checks to minimize technical errors, including visual matches of an animals group assignment to a designated color, scanning of barcode on dosing vessel prior to start of each group to verify that the correct test article concentration is being used, and scanning of barcode on sample tubes to verify that the correct tube is being filled.
• Master and study lexicons result in consistent and accurate use of measurement terminology.
• Seamless tracking of clinical pathology samples from collection in the animal room, to receipt in the clinical pathology lab, to analysis by the clinical pathology instrumentation with direct data transfer from the instrumentation to the Pristima system.
• Statistical analysis integrated into data reports. If a statistical evaluation is requested that is outside our normal procedure, a specific statistical decision tree can be created from an existing dictionary of statistical tests and incorporated into each individual report.
• Data Reports are available in a variety of formats (PDF, Word, Excel, HTML, CSV, text)

We will also now have the ability to record data for teratology/reproductive toxicology studies on-line and easily generate data tables.  Previously, the majority of data we collected for these studies was generated on paper and then manually tabulated, followed by 100% QC check of all the data points to ensure the accuracy of the transcription. With online data collection and table generation, there will be a reduction in time needed to complete study reports.

About Xybion Medical Systems
Since 1977, Xybion has been the enterprise system partner of choice for life science product companies and scientific research organizations worldwide. In addition to Pristima, Xybion provides professional services, consulting, training, and validation activities to clients around the world.

Calvert’s commitment to quality, customer service, and flexibility is now extended even further with the addition of intravenous continuous infusion as part of our parenteral route of administration.

Intravenous continuous infusion is commonly used in the clinical administration of drugs such as chemotherapeutics, antibiotics, etc..  When a compound needs to be delivered by continuous infusion clinically, using intravenous continuous infusion as the preclinical route of administration is required to mimic future clinical trials.

To perform the procedure, animals are surgically implanted with in-dwelling catheters. Each animal on study requires an infusion setup consisting of a harness (which the animal wears to connect the catheter to the infusion setup), a tether that connects the infusion line to the harness and protects the infusion line from the animal, and a swivel which allows the animal to move relatively freely within the cage.  These items are all purchased for each individual animal on a study by study basis. Calibrated infusion pumps are then used to control the rate of dose administration to each animal over prolonged periods of time.

When Calvert first considered adopting the continuous infusion procedure, the technology with the catheter implantations, infusion pumps and infusion setups was not as advanced as it is today. The improvements in technology have lead to an overall reduction in the number of technicians required to perform each study.  This now allows us to focus more time on the individual study and communication with our clients.

By now offering continuous infusion, clients requiring this service can now have now get access to Calvert’s commitment to quality, customer service and excellent reputation in the industry, and to benefits that they may not get elsewhere.

Join the Calvert Labs team at our west coast conventions this fall:

30th Annual Meeting of the American College of Toxicology
Palm  Springs Convention Center
November 1-4, 2009
Booth #202

2009 AAPS Annual Meeting and Exposition
Los Angeles Convention Center
November 9-11, 2009
Booth #432

Planning to attend? Let us know. Contact Jeff Tippett at 919-854-4453 or jeff.tippett@calvertholdings.com. We would love to schedule a time to meet with you!

Calvert Laboratories, Inc. recently distributed three employee awards for exemplary merit in 2008. These awards are based upon recommendations by the Calvert staff, and each recipient is selected from these nominations.

The winners for 2008 are:
Study Director of the Year – Jay Pennell, Study Director, Toxicology
Technician of the Year – Carrie Olechna, Research Associate, Toxicology
Support Person of the Year – Dennis Roe, Team Leader, LAR

Calvert congratulates these employees and wishes them the best in their continued career.

Cesar Mujer, PhD, a study director in Calvert Laboratories toxicology department, recently collaborated with Dr. Vito DelVecchio on a chapter for the book, “Mass Spectrometry: Instrumentation, Interpretation, and Applications.” Dr. Mujer’s work can be found in Chapter 12 of the book and speaks of bioterrorism. As defined in this portion of the book, bioterrorism is the intentional use of pathogenic microorganisms or toxins to cause disease or death in plants, animals and humans.

The chapter deals with a short historical account of bioterrorism, the Geneva protocol of 1925, and the biological weapons convention of 1972. It also touches on the categories of biothreat agents and the use of mass spectrometry (e.g., MALDI-TOF MS, LC-MS/MS, SELDI-TOF-MS) in proteomics particularly in the rapid and accurate identification of biological threat agents. Identification of these threat agents using mass spectrometry is essential in confirming that a bioterrorism event has occurred and will determine appropriate countermeasures to protect public health.

Also discussed are the challenges in using biomarker proteins for bacterial strain identification, diagnosis, vaccine development, and therapeutic agent development. One specific area of interest is expression profiling of biological samples such as serum or plasma which can be used for early detection of infection. For instance, serum proteomics profiling assay has been used to distinguish patients with acute SARS from patients with fever and influenza with 100% accuracy.

The book, “Mass Spectrometry: Instrumentation, Interpretation and Applications” is currently available for purchase on Amazon.com as well as a number of other outlets. It was published this year (2009) by John Wiley and Sons, Inc., Hoboken, N.J. as part of Wiley-Interscience Series on Mass Spectrometry. The book was edited by Rolf Ekman, Jerzy Silberring, Ann M. Westman-Brinkmalm and Agnieszka Kraj.

Several members of the Calvert Laboratories staff recently authored a poster titled “A Percutaneous Intrasalivary Gland Dosing Technique in Rats”, and their work was presented November 9-13, 2008 at the 59th American Association for Laboratory Animal Science National Meeting in Indianapolis, IN. Employees who assisted with this authorship were Jaclyn G. Tontini, DVM, Laurie M. Serfilippi, VMD, DACLAM, Danielle R. Pallman, BS, LVT, Cesar V. Mujer, Ph.D., Charles B. Spainhour, VMD, Ph.D., DABT. Dr.Laurie Serfilippi had the honor of presenting the poster at the meeting.

This technique was developed as a result of one of Calvert Labs’ client requests to developing a non-invasive and consistently repeatable dosing technique to deliver test article to the submandibular salivary glands of rats. Since the company strives to personalize and optimizing client service, the Calvert team went to work to address this challenge and develop an appropriate technique.

The first consideration in the quest to solve this puzzle was to use surgery and ultrasound to aid us in locating and localizing the glands for injection. However, due to equipment costs, invasiveness, and the need to dose multiple times, everyone decided to look into other options. During the process, the team found that if they anesthetized Sprague Dawley rats, placed them in dorsal recumbency, and extended their necks (which were shaved and prepared with alcohol), the glands would be better visualized under the skin. The technicians could then use tissue forceps to isolate each individual submandibular salivary gland, and then they could easily inject test article percutaneously into the gland’s parenchyma.

To insure that this theory was something of value, the staff initially tried the procedure on training animals using Evan’s Blue dye to ensure that the glands themselves were actually being injecting. The success rate during the initial training process was around 90% but as the technicians became more proficient, the rate grew to around 95%.

To further study the effects of this dosing procedure, staff members dosed a couple of studies using the technique. The study animals did well post-injection and showed no obvious adverse effects to the injections or anesthesia. The staff members further confirmed that the test article injections were placed in the proper location through findings on histopathology. As a result, the members of Calvert Labs now feel reasonably confident that this technique could be considered along with surgical exposure or ultrasound guidance as another option to deliver test article to the salivary glands in the rat model.

Click here to download a PDF of the poster.