In Vitro Validation
Microcomputed Tomography, University of Pittsburgh
Director: Konstantinos Verdelis, DDS, PhD
Equipment: Scanco VivaCT 40; Scanco µCT50
The CCR microCT Core suite occupies 300 square feet on the fourth floor of the Salk Pavilion building. This core uses an in vivo Scanco VivaCT 40, Scanco Medical, scanner based at the Bridge Side Point II building, just over a mile from Salk Pavillion. This equipment is capable of intermediate resolutions (10.5-40µm voxel resolution) imaging of live or harvested tissues. The microCT Core also includes a newly acquired Scanco µCT50, Scanco Medical high resolution (0.4-30µm voxel resolution) ex vivo scanner. The Scanco µCT50 scanner is capable of imaging wide objects (up to 10cm extended field of view) with a wide range of densities (up to 90Kvp beam energy range for implant imaging). It has a high throughput capability through the use of an autoloader and pre-programming of individual sample runs. Applications range from imaging of hard tissues to biomaterials and soft tissues (like vasculature, embryonic tissue and joints and ligaments). The CCR microCT Core facility employs a dedicated technical specialist and has processing and user-training areas for the use of Scanco, Bruker-Skyscan and Mimics 3D morphometry software on dedicated HP Raid tower and Dell workstations.
Histology, University of Pittsburgh
Director: Charles S. Sfeir, DDS, PhD
Equipment: Automatic Tissue Processor; Embedder; Stainer; Microtomes; Microscopes including: diffraction, brightfield, dissecting and fluorescent micropes
The CCR histology suite occupies 450 square feet on the fifth floor of the Salk Pavilion building. It is dedicated to the histology of soft tissues, decalcified and undecalcified hard tissues, interfaces of tissues with biomaterials such as implanted metal devices, histomorphometry, as well as immunohistochemistry and in situ hybridization analysis. A dedicated technical specialist is responsible for the operation of this core, including training and supervision of users. A range of microtomes (rotary, heavy duty controlled-speed and cryostats) is available to match the particular specimens and purpose of analysis. The suite houses an automatic tissue processor, embedder and stainer equipment, which make high sample turnover possible. The instruments used include diffraction, brightfield and fluorescent microscopes; ones equipped with cameras, as well as several dissecting microscopes. In addition to using widely established techniques for soft tissues, the core has developed and uses methodologies to perform advanced histological and histomorphometric assessments of mineralized tissues (based on PMMA and like proprietary resins, Technovit processing). Histomorphometry is performed using high quality scanners and specialized software (such as that created by Bioquant) on dedicated workstations.
Biomechanics, University of Pittsburgh
Director: Alejandro Almarza, PhD
Equipment: Dual Column Instron testing system; Single Column MTS testing system; Buehler Microhardness Tester
The Biomechanics Core is housed within the Center for Craniofacial Regeneration on the fourth floor of Salk Pavilion with areas for specimen preparation and mechanical testing. The core uses a dual column Instron material testing apparatus, a single column MTS testing apparatus and a Buehler microhardness tester. Mechanical properties of hard and soft tissues and bone are characterized by a range of tests, such as unconfined compression, uniaxial tension, 3 and 4 point bending, and puncture. Multiple load cells on instruments provide a range of mNewton to kNewton for testing, strain gauges and video tracking, which are used to validate deformations. The systems are also equipped to test new materials, including metal alloys.
Materials Fabrication & Characterization, University of Michigan
Michigan Center for Materials Characterization
Michigan Center for Materials Characterization (MC)2 at the University of Michigan’s College of Engineering supports a diverse multi-disciplinary user-base of more than 450 users from various colleges and department across the UM campus, more than 100 internal research groups, and 20 non-academic companies. The mission of (MC)2 is to provide cost effective, efficient, safe, and socially responsible access to advanced characterization equipment and expertise thereby promoting, enabling, and encouraging cutting-edge education, research, and business development.
Available equipment includes the following:
- Philips XL30 FEG SEM
- FEI Nova NanoLab
- FEI Quanta 200 3D
- FEI Helios
- JEOL 2010F AEM
- JEOL 3011 High Resolution Microscope
- JEOL 2100 High Resolution STEM Cs-Corrector manual
- JEOL 3100R05
- Cameca LEAP 3000 XHR
- Kratos Axis Ultra X-ray Photoelectron Spectrometer
- Digital Instruments Nanoscope Microscope
- FC4E Low Temperature Sectioning System
Lurie Nanofabrication Facility
Lurie Nanofabrication Facility (LNF) at the University of Michigan provides equipment and processes for research on silicon integrated circuits, MEMS, III-V compound devices, organic devices and nanoimprint technology. We also encourage researchers from non-traditional disciplines to make use of our processes, such as metal and dielectric coatings, vacuum processes, fabrication of micro and nano components and metrology tools.
- Mercury Porosimeter (Autopore V) Micromeritics Instrument Corporation)
- Particle Sizing (Mastersizer 2000) (Malvern)
- Particle Analysis (ZetasizerNano) (Malvern)
- Nanosight: Characterizing Nanoparticles: Visualizing, Sizing and Concentration (Malvern)
- Differential Scanning Calorimeter (NanoDSC) (TA Instruments)
- Differential Scanning Calorimeter (Discovery DSC) (TA Instruments)
- Isothermal Titration Calorimetry (NanoITC) (TA Instruments)
- Thermogravimetric Analysis (Discovery TGA) (TA Instruments)
- Circular Dichroism Spectrophotometer (CD J1700) (JASCO)
- Circular Dichroism Spectrophotometer (CD J815) (JASCO)
- Circularly Polarized Luminescence Spectrometer (CPL-300) (JASCO)
- Circularly Polarized Luminescence (CPL)
Mechanical & Functional Assessment, University of Michigan
School of Dentistry
Laboratories devoted to characterizing the processing-composition-structure-property relationships of synthetic and natural biomaterials and tissue
- Instron 8521 servo-hydraulic biaxial mechanical testing machine – human and large animal tissues, synthetic materials
- Admet electromechanical material testing system – small animal tissues, scaffolds
- Custom-designed micromechanical testing system – small animal tissues, scaffolds
Michigan Integrative Musculoskeletal Health Core Center
Functional Assessment Core – physiological testing, microsurgery models, muscle mechanics, tendon testing, bone testing, custom fabrication/machining, fracture healing/surgical models.
- Hysitron TI950 TriboIndenter With Fluorescence
- MTS Bionix Servo-Hydraulic Testing System
- Bose Electroforce 3300AT
- Bose Electroforce 3200.
- MTS Model 810 Servohydraulic Uniaxial Testing
- MTS Servohydraulic Torsion Testing
- Instron 8511 Servohydraulic Uniaxial Testing
Histology, University of Michigan
The histology core facility at the University of Michigan’s School of Dentistry provides histological services using standard histological techniques. The core specializes in sectioning of hard (demineralized) tissues.
- Nikon E800 light microscope (with Photometrics coolsnap momochrome and Nikon DS-Fi1 color cameras) with bright field, dark field, and fluorescence (FITC, TRITC, and triple- FITC, TRITC, and DAPI). Histomorphometric measurements can be done with NIS Elements software.
- Leica AS LMD, laser micro dissection microscope (with fluorescence).
- Leica CM1850 Cyrostat
Micro-CT, Microscopy, Image Analysis, University of Michigan
The MicroCT core facility at the University of Michigan’s School of Dentistry provides the following capabilities:
- Scanco μCT 100 micro-computed tomography system provides high resolution scans of radio opaque specimens such as bone, contrasted soft tissue, bio materials, etc.
- Accommodates large specimens (up to 100mm diameter x 120mm length)
- Capable of 2.5 μm resolution (highest resolution is not available at all sample sizes.) Typical resolution for mouse bones is between 6 – 12μm.
- Visual outputs: 2D and 3D images, movies, FEA meshes
- Main bone parameters from analysis: TV (total volume [mm3]), BV (bone volume [mm3]), BV/TV, Tb.Th (thickness of the trabecular structure), Tb.N (number of trabeculae), Tb.Sp (trabecular separation)
Center for Molecular Imaging
The Center for Molecular Imaging at the Biomedical Science Research Building is a shared resource aimed at providing state-of-the-art imaging services for the research community. The BSRB CMI offers a diverse range of imaging systems including two IVIS bioluminescent/fluorescent imaging systems, an Agilent 7 Tesla horizontal bore MRI system, a Siemens PET/CT, a Trifoil Imaging SPECT/CT, and a Bruker CT system.
The NCRC CMI offers an in vivo IVIS Spectrum optical imaging system capable of bioluminescent and fluorescent imaging as well as dedicated analysis space, animal procedure space and animal housing. The NCRC CMI also has a 4.7 Tesla Agilent MRI system that is capable of medium-to-large animal imaging.
- IX83 Microscope for Live Cell & Hanging Drop Imaging (Olympus America, Inc.)
- Structured Illumination Microscope System (SIMS) (Carl Zeiss Microscopy)
- Scanning Confocal System (Nikon Instruments)
- Mantra Quantitative Pathology Workstation (Perkin Elmer)
- Fluorchem M Imaging System (ProteinSimple)
- XFe96 Extracellular Flux Analyzer (Seahorse Bioscience, Inc./Agilent)
In Vivo Validation
Pre-Clinical Animal Models and Testing, University of Pittsburgh
Director, Shawn Bengtson
McGowan Center for Preclinical Studies (CPCS)
The University of Pittsburgh is well equipped with facilities and resources to help innovators progress through the pre-clinical phase of research. MPWRM innovators will have access to the McGowan Center for Preclinical Studies (CPCS) which is dedicated to supporting animal research. The CPCS was established to provide members of academia and industry with state-of-the-art facilities for proof-of-concept translational research in medical device and other regenerative medicine areas. In addition, the Center provides manufacturer-approved surgical training for implantation of medical devices such as artificial hearts, and ventricular assist and orthopedic device and conducts scientific and engineering assessments of devices and procedures prior to their translation to the clinic.
The animal is equipped to house up to seven large animals in quarantine with regular housing post-quarantine, either individually or communally. There is a large open surgical prep and stat area which is capable of providing routine blood gas and hematocrit values for test subjects. Additional biological testing is done offsite at contracted veterinary diagnostic laboratories. There are two large animal operating suites, one of which also serves as a necropsy suite, meeting the requirements of a modern clinical OR. A fully staffed Intensive Care / Observation area is capable of long-term post-operative care with monitoring provided 24 hours a day, 365 days a year as needed. Small animals are housed in four isolated cubicles with a dedicated adjacent prep/surgery room. Surgical assistance and post-op monitoring is performed by highly skilled and trained members of the CPCS staff and is overseen by University of Pittsburgh veterinarians.
The CPCS Facility includes:
- Quarantine Rooms
- Surgical Stat and Surgical Prep Area
- A Main Operating Suite fully equipped surgical facility meeting the requirements of a modern clinical OR with capabilities including fluoroscopy, ultrasound, advanced life support and patient monitoring systems
- An Intensive Care / Study Conduct Adjacent to the Main Operating Suit and Stat Lab, this area is dedicated to long-term care and treatment of implanted and critically ill animals. Located centrally with direct visual access to these rooms, a monitoring/nursing station is manned by trained Critical Care/Veterinary Technicians supporting round the clock critical care, treatments, monitor vital signs, and collect study specific data 24 hours a day, 365 days a year per study requirements.
- Necropsy Suit with fully equipped operating room intended for device explantation, tissue collection and full necropsy.
- Data Archiving Facility that is a secure facility with limited access (assigned Archivist by Facility Management) is maintained for the preservation of raw study data, study protocols, approved and validated ”original” standard operation procedures (current and historical), study personnel training and qualification record and all pertinent documentation related to study conduction. As required by the standard operating procedures entailing Data Archive maintenance, all documentation, once submitted to the Archive, is catalogued and accessed through documented request to the Archivist or as otherwise specified by Test Facility Management.
In addition, innovators will have access to a second pre-clinical facility which is maintained by the University of Pittsburgh, Division of Laboratory Animal Resources (DLAR) staff and is equipped to house both large and small animals in barrier facilities. There are 17 rodent housing rooms with 10 dedicated procedure rooms. Large animals are housed in several large rooms that can be adapted to function as quarantine or regular housing as required. The rooms have pens that can be modified to allow for either individual or communal housing as needed. In addition to the large animal rooms there are two rooms dedicated to rabbits, ferrets and/or cats. There is a surgical prep room with two large animal operating suites meeting the requirements of a modern clinical OR. Adjacent to the surgical suites is a large post-operative observation room and a dedicated necropsy room. Surgical assistance and post-op monitoring is performed by highly skilled and trained members of the DLAR surgical support staff supplemented by CPCS staff as needed and is overseen by University of Pittsburgh veterinarians.
Animals are housed within two locations at the University of Pittsburgh. Both facilities are capable of housing large and small animals, with sufficient space for in-coming quarantine, general housing, surgery and post-operative observation. Approximately 11,700 square feet has been allocated for these functions. The building environmental conditions meet or exceed the requirements specified by the University of Pittsburgh’s IACUC office. The animal housing areas are subject to routine inspections by University of Pittsburgh’s Institutional Animal Care and Use Committee (IACUC) and USDA staff and are fully AAALAC certified. Species ranging from rodents to sheep, cows, and sub-human primates can be accommodated at these facilities
Prototyping and Process for Manufacturing, Wyss Institute:
Ability to produce:
- Biopolymer based hydrogels/cryogels
- Polymer-based porous scaffolds
- Polymer-based nano/micro particles
- Lipid-based nano/micro particles
- Polymer-based aggregates
- Drug release profiling by HPLC, SEC, GPC, Ion Exchange chromatography, fluorescence, luminescence, absorbance, Native-PAGE, SDS-PAGE, Western Blots, Agarose Gels, ELISAs/Titers, LC/MS, numerous other product specific assays including cell based assays.
- Material characterization: Dynamic light scattering, rheology, NMR, IR, SEM, TEM, numerous other product specific assays.
- Process and analytical qualification and validation capabilities
- Support good laboratory practice (GLP) toxicity & biocompatibility testing, regulatory submissions, and in some cases early stage human clinical trials.
- LC/MS, fluorescent/absorbance plate-reader
- HPLC (reverse phase, size exclusion, ion exchange, hydrophilic)
- Dynamic Light Scattering DLS
- Zeta potential (Zetasizer)
QC and Data Management
Standardization and Quality Control
Information will be posted at a later date
Statistical and Clinical Data Management
Information will be posted at a later date
Business Strategy Services
MPWRM Resource Center’s commercialization planning services are designed to provide innovative commercialization assistance for investigators to aid the realization of successful business milestones. Investigators will be provided guidance and education about the commercialization process related to the development of their ITP projects.
Specific guidance can be obtained by contacting Andrew Brown at firstname.lastname@example.org.
Intellectual Property Management
MPWRM Resource Center’s Intellectual Property experts uses their experience and expertise to unearth, evaluate, analyze, and broadly identify IP opportunities related to DOC technologies. Our process will assist investigators in thoroughly understanding their technology and patent novelty, resulting in stronger protection of your assets.
Specific guidance can be obtained by contacting Andrew Brown at email@example.com.