June 16, 2011
Triclinic Labs Adds Large Molecule Biophysical Analysis Services
Today, Triclinic Labs, Inc., the leader in advanced techniques and services for solid-state small molecule development, announced it has launched a comprehensive suite of large molecule biophysical characterization and consulting services. “The goal of the Triclinic Large Molecule practice is to provide comprehensive and rapid analysis of therapeutic and discovery proteins as well as other macromolecules” said Dr. David Bugay, Triclinic’s Chief Scientific Officer. He added “by adding these services and recognized experts we seek to provide complete information about the kinetics and structure of proteins, regulation of protein expression, protein modification, protein:protein interaction, and protein function during different stages of development”
Leading the practice are Drs. Lake N. Paul and John W. Burgner.
Lake Paul, Ph.D. received his doctorate in Structural Biology and Biophysics from Purdue University and most recently has held the position of Biophysics Research Specialist at Purdue University in West Lafayette, IN. During Dr. Paul’s tenure at the National Institute of Environmental Health Sciences and Purdue University, he applied LC/MS techniques to compliment traditional structural biology and demonstrated that protein analyses under Matrix Assisted Laser Desorption Ionization MS conditions coincide with the solution data obtained from analytical ultracentrifuge.
John W. Burgner, Ph.D. received his doctorate in Biochemistry from Purdue University and was most recently Director, Biophysical Analysis Core, Bindley Bioscience Center at Purdue University until retiring in 2009. Dr. Burgner is a recognized authority on hydrodynamic and thermodynamic analysis of macromolecules and has an extensive publication history.
Dr. Paul and Dr. Burgner will bring their extensive knowledge in the use of Analytical Ultra Centrifugation (AUC), Surface Plasmon Resonance (SPR), Liquid Chromatography coupled with Mass Spectrometry (LC/MS), as well as other Structural and Kinetic Characterization techniques to bear on client research needs. Both Dr. Paul and Dr. Burgner have extensive experience in the biophysical characterization of large molecules used in drug discovery and development.
For more information and a complete list of large molecule characterization services Triclinic is now offering please click here.
June 1, 2011
Triclinic Labs Adds Process Optimization and Litigation Expert to its Pharmaceutical Consulting Group
Today Triclinic Labs announced the addition of Ken Moder, PhD., a seasoned organic chemist, to its consulting staff. Dr. Moder’s background includes process optimization focusing on process flow and equipment sets, intermediate or drug product cost reduction, chemistry optimization or re-designs, drug substance and product crystal forms, and avoidance of potential environmental impact concerns for chemical intermediates through drug product. Dr. Moder brings 28 years of pharmaceutical chemical processing and project leadership experience from bench scale through large-scale manufacturing. Dr. Moder spent more than 25 years at Eli Lilly and Company in various leadership roles.
Dr. Moder has more than 10 recent peer-reviewed publications and 8 US patents. The scope of his publications and patents include chemical synthesis, process optimization, reactive metal alternatives, and process and warehouse safety concerns. Ken focuses on optimization efforts within current NDA guidelines or new future process designs. His areas of expertise include writing and reviewing the processing portion of IND’s, NDA’s, and veterinary product submissions. He has experience resolving issues with the FDA, the CMV, and the Patent Office as well as legal experience as an expert witness for process case litigation.
For more information please contact Triclinic Labs.
May 1, 2011
Triclinic Adds Bulk Powder Characterization and Powder Interaction Services
Today Triclinic Labs announced it has added extensive Bulk Powder Characterization and Powder Interaction Analysis services to its full-service analytical chemistry and drug development capabilities. Triclinic utilizes surface science to assess surface, physical and chemical properties as well as develop strategies for formulation with emphasis on dry powder functionality either for oral or inhaler dosage forms. With experience with tablets, hard and soft gelatin capsules, solid dispersions, and self-emulsifying systems Triclinic's new services cover a wide range of pharmaceutical drug products. The Powder Characterization Group specializes in analysis of physicochemical properties of powders and interactions among powders (agglomeration and segregation) as well as surface properties as they relate to functionality of drugs and excipients. Teresa Carvajal, Ph.D. leads Triclinic's Powder Characterization group.
''I am pleased to join Triclinic's ever growing list of experts dedicated to advanced pharmaceutical and fine chemical development"' said Tere Carvajal, Ph.D. "We intend to not only provide exceptional powder characterization and powder interaction services but also develop cutting-edge methods for process induced analysis such as milling, mixing, flow analysis and property prediction and agglomeration and segregation prevention." she added.
For more information please contact Triclinic Labs
January 12, 2011
Triclinic Installs New State-Of-The-Art Cilas 1180 Laser Diffraction Particle Size Analyzer
Today Triclinic Labs announced it has installed a Cilas 1180 LD Particle Size Analyzer. The 1180 is a three laser instrument designed to provide the ultimate level of performance flexibility, and reliability. The CILAS 1180sets a new standard in particle characterization. Its integrated wet and dry dispersion modes, built in video camera and short optical path make it the most versatile instrument available anywhere. The unique design of the 1180 provides a measurement range from 0.04 to 2,500µm while maintaining an extremely small footprint. The 1180 can switch from liquid to dry samples with no operator intervention.
''We selected the Cilas 1180 LD Particle Size Analyzer because it offers exceptional performance for both liquid and dry materials. The software is intuitive and the microscopic interface provides another level of imaging not easily found in contract development labs,"' said Dave Bugay, Ph.D. Triclinic's CSO. Triclinic will utilize the instrument for method development, materials characterization, and in support of intellectual property matters.
For more information please contact Triclinic Labs
December 8, 2010
Triclinic Installs New State-Of-The-Art Rigaku SmartLab X-Ray Powder Diffractometer
Today Triclinic Labs announced it has installed a Rigaku SmartLab advanced XRPD system. The SmartLab high-resolution diffraction system represents the state of the art in fully automated modular XRPD systems. The system incorporates a high resolution theta/theta closed loop goniometer drive system, Cross Beam Optics, an in-plane scattering arm, and a fully automated optical system to make advanced measurements possible. Winner of the 2006 R&D 100 Award for technical innovation, the SmartLab is design for completely automated analysis of powders, solid-materials, thin films and other advanced materials. Powered by Guidance, Rigaku's revolutionary knowledge based software package, SmartLab uses fully developed measurement packages for completely automated measurement of thin films, nanomaterials, powders, and liquids. Measurement of powder diffraction, glancing incidence diffraction, in-plane diffraction, X-ray reflectivity, and small angle X-ray scattering (SAXS) measurements are possible. The new instrument provides superior sensitivity and maximizes Triclinic's capability to fully analyze solid pharmaceutical materials (API, drug products), and specialty chemicals.
Triclinic also plans to use the instrument in support of its leading solid-state discovery and development programs and in support of its Advanced Computational Chemistry program for small and large molecule structure and stability determination. Using off-the-shelf and in-house software algorithms Triclinic's Advanced Computational Chemistry program is designed to extract maximum information from small amounts of material and laboratory-generated spectra.
Another role of the new Rigaku instrument at Triclinic will be its use in X-ray diffraction mapping studies, a powerful complement to Triclinic’s existing IR mapping and RAMAN and ToF/SIMS imaging capabilities.
"This instrument provides Triclinic Labs with the very best data possible and puts us at the leading edge of analysis and research and development in solid-state chemistry" said Pat Stahly, Ph.D., Triclinic's COO.
For more information please contact Triclinic Labs.
December 1, 2010
Triclinic Labs Builds New Laboratory Space
Today Triclinic Labs announced it has opened an additional 5000 square feet of laboratory and office space in the renovated Innovatech Building. The new facilities will house state-of-the-art instrumentation, experimental and office space for newly created scientific positions, and conference and employee common areas. With the expansion Triclinic is adding HPLC, dissolution testing, thermal and spectroscopic techniques, and other capabilities to its extensive list of analytical capabilities and services. The new lab will allow the addition of ten positions in the next 24 months.
"We're excited to be able to add additional scientific capabilities and capacity to our extensive physical and analytical chemistry service offerings. Our goal is to provide novel services for our clients with this current expansion." said Shawn Comella, Triclinic's CEO. "The demand from our clients for cutting-edge approaches to physical and analytical chemistry development has been overwhelming. We're pleased to be able to now provide the additional techniques and expertise our customers have requested of us. Despite a recovering economy, we continue to add jobs at a regular interval and reinvest in the business and our small and large molecule research and development programs. We will continue to do the things necessary to provide one of a kind service and capabilities." he added.
This is the third expansion for Triclinic Labs since its inception in April, 2009.
For more information please contact Triclinic Labs.
November 15, 2010
Triclinic Launches New XRPD Computational Analysis Services
Today at AAPS Triclinic Labs announced it will begin to offer extensive XRPD analysis through its Computational Chemistry group.
XRPD data can be much more useful than just providing a phase fingerprint. To get the most from XRPD one needs an XRPD instrument, appropriate software, and technical expertise. The first two are readily available but the last is harder to come by.
Currently at Triclinic, we have a fully configurable Scintag diffractometer, a state-of-the-art Rigaku SmartLab System, and a world class in-house technical expert. These capabilities allow us to extract much more information from an XRPD pattern than simply a finger-print identification. For example, we can index a powder pattern to determine the dimensions of the unit cell from XRPD data (vs. requiring synchrotron data). This requires accurate data, sophisticated software, and expert interpretation of the data. With the open design, configurable Scintag diffractometer it is possible to collect indexable powder patterns from small amounts of pharmaceutical materials (e.g. 10 mg of acetaminophen).
With an indexed pattern one may have an:
- Assurance of phase purity
- Identification of a phase as a probable hydrate or solvate based on unit cell void space
- Efficient pattern matching (in screening, for example) based on expected peak positions calculated from the unit cell
- Improved knowledge from indexing that can make up for poor-quality data resulting from small sample sizes Investigation of process-induced product changes leading to XRPD changes
- Understanding that A "new peak" showing up in the XRPD pattern of a material produced using a commercial process can be a symmetry-disallowed peak that arises because of defects rather than being a peak from a contaminant
- Excellent method to develop solid mixture quantitative analysis
For more information please contact Triclinic Labs.
August 1, 2010
Simon Bates Joins Triclinic Labs
Dr. Simon Bates , a physicist and recognized leader in the field of molecular order, has joined Triclinic Labs effective August 1, 2010.
Dr Simon Bates has close to 30 years experience working with X-ray and Neutron diffraction characterization of the solid state. For the last 9 years, he has been working on characterization and modeling of pharmaceutical materials including both API and drug product. Before moving to Triclinic Labs, Dr. Bates worked at SSCI as a Research Fellow and a Principal at Aptuit Consulting. His work on pharmaceutical systems at SSCI/Aptuit lead to 13 peer reviewed publications and more than 10 patent applications.
Dr. Bates’ expertise also includes computational modeling of molecular systems, computational methods for IR Spectroscopy and Thermal Analysis, and Chemometrics. His expertise has allowed Dr. Bates to work as a scientific expert in numerous patent litigation and patent prosecution cases. Dr. Bates has over 40 peer reviewed international publications and has been an invited speaker at many scientific conferences.
For more information please contact Triclinic Labs.
August 1, 2010
Triclinic Expands Senior Scientific Staff
Triclinic Labs announced it has added David Jonaitis to its senior research staff. Jonaitis has considerable organic and inorganic solid-state research experience.
"We're thrilled to add Dave to our staff" said Dave Bugay, Ph.D., Triclinic's CSO. "Dave brings a wealth of knowledge and additional experience to our team. He has conducted hundreds of solid-state research and development projects for the pharmaceutical industry. He is extremely customer focused and his attention to detail will provide our clients with thorough and highly efficient scientific services."
