Our consulting services are available to aid start-up, and small-to-large companies. Over 30 years of combined academic, industry and contract research experience developing and testing drugs, biologics, medical devices and combination products for a variety of applications (including rheumatological, orthopedic, neurological, cardiovascular, vaccine and cancer therapeutic applications) uniquely positions us to aid our clients in their product development process. Years of experience working with and developing large and small preclinical models and designing both preclinical and clinical studies to evaluate product candidates, positions us well to advise our clients on product-driven designs necessary to appropriately test the safety and efficacy of their product candidates. We welcome the opportunity to assist you with your product development needs.
In our GLP-compliant histopathology laboratory, experienced technicians produce routine and specialty histology slides. Our facilities are fully equipped and include a cryostat for frozen sections, microtomes for cutting paraffin and plastic sections, x-ray and digital imaging systems for high quality explant radiographs of both large (including spines) and small specimens, precision trimming, and cutting systems, as well as automated tissue processors and staining equipment to ensure high quality, reproducible results.
Our experience-based knowledge of comparative anatomy and temporal changes associated with disease models, enables us to ensure clear identification of the region of interest .
H&E stain as well as any specialty stain you may require for visualization of cells and tissue at the region of interest can be completed.
In addition to routine histology, Histion specializes in histology for the Medical Device Industry. Our state-of-the-art equipment enables precision cutting and grinding of both hard and soft tissues containing medical devices, ensuring accurate visualization of the region of interest. Our experience is broad and spans a variety of species and implant materials including, but not limited to, PMMA, PEEK, PLA, PLG, Delrin, Nitinol, CoCr, TiAlV, SS, ceramic and metal/polymer, polymer/biologic, and metal/ceramic combination devices. Even with biomaterials that are “difficult” or considered “impossible” to process, our extensive knowledge of materials chemistry enables preservation of intact tissue/material interfaces and even recovery from poorly processed specimens.
Our experience-based knowledge of comparative anatomy and temporal changes associated with surgical and injection models, enables us to accurately capture the region of interest.
Stains for specialty histology include Toluidine blue, Stevenel’s blue/van Gieson and others, modified in-house, specifically for plastic-embedded specimens.
Microscopic analysis is completed by highly qualified, experienced Anatomic Pathologists. Both qualitative and semi-quantitative microscopic analyses are offered.
Quantitative analysis can also be completed using a state-of-the-art imaging system and calibrated images. Both hard and soft tissue section analysis can be completed for any select region of interest identified microscopically, as a function of length or area. Our scientists are highly trained in histomorphometric techniques on validated systems to enable routine or specialty analysis designed to accurately measure product performance.
Some typical measurements include:
Immunohistochemistry (IHC) labeling using routine, published and novel methods are also offered to our clients. Our extensive experience has enabled us to successfully develop new immunolabeling methods for paraffin and plastic-embedded sections that ensure clean results, even when using species-mismatched antibodies on tissue that contains implants. Our developed methods include immunolabeling of ground sections taken from methyl-methacrylate-embedded tissues containing medical devices.
Radiographs enable visualization of new bone and implants and can be taken of small or large specimens (e.g., spines and femurs containing total hip replacements) with our state-of-the-art x-ray and digital processing equipment. Digital processing can also provide a powerful analytical tool for our clients who have a need to evaluate bone density.
Study data is compiled and analyzed, then comprehensive study reports that include photomicrographs for illustrative purposes, are written by professionals with FDA and other regulatory body submission experience. Flexible formats enable short, concise reports for proof of concept work or fully comprehensive reports that are required for regulatory submissions. Our continuing success has been achieved with a broad range of currently marketed medical devices, drugs, biologics and combination products.
Histion partners with well-known, reputable laboratories that have unique knowledge and experience to provide quality 3-dimensional images and analysis that provide added value to preclinical studies. Our partners have over 20 years-experience in the field.
Histion partners with well-known, reputable laboratories that have unique knowledge and experience to provide mechanical testing of implants, pre-implantation and post-implantation, as well as soft (e.g., cartilage) and hard (bone) tissues; adding value to your pre-clinical studies. Our partners have over 30 years-experience in the field.
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