Frequently Asked Questions
Why should I choose to work with TPS?
TPS has the neuropathology, neurohistology and stereology/morphometry experience and expertise to investigate neuroactive therapies and devices in a manner that will speed up your development program and help you avoid the need to do repeat studies. In any given year, we evaluate dozens of new and existing drugs, biologics and devices. Our collective body of knowledge will help you anticipate and satisfy impending scientific and regulatory issues. Whether you need a pathology consultation, necropsy support, specialized histology, stereology, or other research involving the precinical development of neuractive therapies, TPS is fully capable. Dr. Mark Butt, DVM, DACVP (curriculum vitae can be downloaded here), President of Tox Path Specialists, has 20+ years of neuropathology experience. Dr. Butt is a frequent consultant and pathologist for the world's largest pharmaceutical firms, a frequent speaker at national and international meetings on topics related to the nervous system, and has acquired extensive experience interacting with the FDA and other regulatory agencies.
What regulatory guidelines is TPS capable of working under?
TPS works in compliance of Food and Drug Administration (FDA) Good Laboratory Practices (GLP), Organization for Economic Cooperation and Development Principles of Good Laboratory Practice (OECD) and Japanese Ministry of Health, Labor and Welfare (MHLW) Good Laboratory Standards.
What types of tissue staining and processing can be performed at TPS?
Please visit our Neurohistology page for additional stains and more detailed descriptions of each.
I need a quantitative analysis (stereology, morphometry) to supplement the qualitative aspects of my study... can TPS help?
Stereologic and morphometric investigations can be of immense value to studies where a quantitative analysis is needed. Quantitative analyses of peripheral nerves, neurons and intraepidermal nerve fiber densities (IENF) are commonly performed at TPS. Although no quantitative investigations are usually as quick as standard qualitative examination, TPS maintains three full stereology/morphometry units to increase throughput and keep your development on schedule. Please visit our Stereology/Morphometry page for more information on additional investigations performed at TPS.
Does TPS provide necropsy support?
Yes, TPS has an experienced necropsy support staff for any animal model. Because necropsy support is very specific to each study, we ask that you please contact our Director of Laboratory Services, Dave Hodge, for additional information. Typically, TPS is able to provide specialized necropsy support for studies with some aspect specific to the nervous system where the tissues will be processed and/or evaluated by our personnel.
My study materials (both physical and electronic) are very sensitive. What type of safe-guards does TPS provide to ensure my materials are kept safe?
TPS' facilities are monitored by a professional security firm 24 hours a day. Entry into the TPS facility requires codes provided only to TPS personnel; the codes change on a regular basis to provide added security.
Electronic data is stored locally on secure TPS servers, accessible only to TPS employees. All servers are on electronic generator backup. All client data are doubly backed up locally. Secure, encrypted daily backups are also maintained offsite.
I have study materials that must kept frozen... can TPS provide this service?
Yes - TPS maintains freezers which have active temperature-monitoring and are on continuous generator backup.
Does TPS provide long-term archiving?
TPS does not provide long-term archiving services. Study materials are kept on site in our secure facility as long as as the study is active at TPS. If you need archiving services, please contact our Director of Laboratory Services, Dave Hodge, who can refer you to businesses who can help.
I need to ship materials to TPS... where should I send them?
We are located at 8420 Gas House Pike, Suite G, Frederick, MD 21701. All study related materials can be sent to the attention of our Director of Laboratory Services, Dave Hodge. If you are sending strictly documentation, it can be sent to the attention of Beth Taylor.
Please visit our Contact page for more information.
How should I package materials sent to TPS?
Due to the sensitive/fragile nature of some study materials, it is very important to package items properly to ensure safe shipment. Below are some of the methods TPS uses when shipping materials, and it is recommended that similar processes are followed when shipping material to TPS.
For all materials sent to TPS, inventory forms are essential to ensure proper chain of custody.
Documentation: Documents should be shipped in either folders or binders to protect from damage during shipping. If documentation is being shipped with other study materials (like slides), the documentation should be placed in folders/binders on top of the other study materials.
Slides: Placed in boxes specifically made to hold slides, facing the same direction and in some logical order. Boxes should have a minimum of the study number visible. A piece of thin bubble wrap or other suitable padding material should be placed between the top of the slides and the lid of the slide box. Individual slide boxes should be taped shut to prevent accidental opening during shipping.
Blocks: Placed into a box in logical order with proper study number identification. Boxes containing blocks should be sealed with tape and bubble wrapped. Resin blocks may be placed in small bags or boxes.
Wet Tissues: Shipped in a secured container (TPS generally uses 6mm heat-sealed bags, sealed into a second bag to prevent leakage) with proper identification information (including a warning label if a hazardous material, such as formaldehyde, is present). Containers should be securely placed within their shipping carton, which should be lined with bubble wrap or other protective material. If the tissues are being shipped frozen, they should be on dry ice with the appropriate safeguards taken. If the tissues are to be shipped cold (but not frozen), then the container should contain commercial cold packs. NOTE: The cold packs should not be in direct contact with the tissue containers as this can lead to freezing of the tissue samples.
Who should I contact for a quote/cost estimate of potential projects?
Due to the highly customized needs of each individual project, a brief consultation with Dr. Butt is recommended for all projects performed at TPS. Please email Dr. Butt with information regarding the goals of your project and a general outline of desired work. Please visit out Contact page for general contact information.
Who should I contact in regards to master services agreements, billing questions, etc?
Any questions regarding service agreements or billing should be directed to Susan Butt.
I am a client and would like to request a visit to the TPS facilities... how should I schedule a site visit?
Please contact our Director of Quality Assurance, Laura Caccese, with any questions regarding site visits. We welcome all clients to see first-hand the capabilities of TPS.