Regulatory GLP Sciences Services
Our team members have more than 90 years of combined, direct experience in the pharmaceutical industry. Our analytical chemistry, quality assurance and regulatory expertise are in the areas of preclinical, Phase I and early Phase II clinical analytical development.
We are a one-stop shop for pharmaceutical companies that wish to outsource their preclinical drug development. We offer total preclinical analytical drug development services to our partnering pharmaceutical companies. Our main emphasis and product is the development of a total analytical tech package required for filing an IND or CTX for our partnering companies. The analytical tech package includes Chemistry, Manufacturing and Control (CMC) drug development, formulations development and analysis, drug metabolism, bioanalytical and pharmacokinetic analysis.
In addition to pharmaceutical knowledge, the Symbiotic Research team has more than 100 years of combined experience in agrochemical and animal health research and development. Our expertise spans the areas of toxicology analysis, formulations analysis, and metabolism and residue chemistry studies.
Plant & Animal Metabolism
Metabolism
Metabolism with a variety of animal and plant species is considered our core business. We understand in-vitro and in-vivo metabolism chemistry applied to plant and animal. We offer complete services under one ‘roof’: From in-life phase to quantitative & qualitative analyses. We are uniquely positioned in this sector where Symbiotic Research, LLC is the direct owner of an in-life facility (Genesis Midwest, LLC) for conducting animal, poultry, fish metabolism studies. Our Genesis Midwest, LLC site is equipped with a full GLP Total Radioactive Residue (TRR) lab which allows all samples to be homogenized at the in-life facility and only portion of the samples shown to contain radioactivity levels above regulatory threshold to be send to our structure elucidation lab in Mt. Olive New Jersey.
Instrumentation in Metabolism Chemistry
Our metabolism group is furnished with all the latest in accurate mass platforms such as AB SCIEX QTOF X500B, Agilent QTOF G6530 and several other QTOF platforms. Our mass spectrometers are interfaced to Model 5C Lab Logic radio detectors and Agilent’s latest UHPLC-1290 INFINITY II liquid chromatography systems. Our team utilizes Harvey Biological Material Oxidizers along with Beckman 6500 Series Liquid Scintillation Counters and Perkin Elmer MicroBeta-II with 12 detectors to screen samples for radioactivity traces. For fraction collection (FC), we utilize both the traditional FC from Pharmacia as well as Agilent’s UHPLC-1290 INFINITY II Fraction collection into various well plates i.e., 96 well plates, HPLC vials etc.
Why utilize Symbiotic Research Metabolism Services
In addition to many decades in-vitro and in-vivo metabolism experience on behalf of our metabolism chemistry staff, as well as all the latest technology in structure elucidation, Symbiotic Research, LLC fully owns its own in-life facility (the Genesis Midwest, LLC), this provides flexibility to our sponsors to choose study director from either site: Wisconsin or New Jersey. Reminder that FDA requires sponsors to select study directors only from the in-life location unless the in-. This is a fringe benefit that our sponsor gets when it comes to choosing a particular study director which they are comfortable to work with from either location.
In a nutshell, we offer a turn-key comprehensive Metabolism study package to our sponsors with a variety of animal and plant species all under one ‘roof’:
From in-life phase to quantitative & qualitative analyses:
- 14C-licensed & AAALAC-accredited animal facility for in-life phase
- GLP- & Non-GLP-conform studies following international guidelines (US-EPA OPPTS/OCSPP, OECD, JMAFF, etc.)
- 14C-tracer and non-labeled studies
- Assessment of metabolic pathways in larger animals i.e. ruminant animals, poultry, and a wide variety of plants
- Confined & field rotational crops
- Preparation of analytical samples: Homogenization and choice of facility for determination of total radioactive residue (TRR) either at Genesis Midwest site or at Symbiotic Research site
- State-of-the-art identification of degradation products & metabolites via variety of mass spectroscopic instruments such as the latest in QTOF from AB SCIEX interfaced to HPLC or UHPLC & Capillary Electrophoresis (CE and CZE-MS-TOF)
- Capacity to set-up large bioaccumulation and fish metabolism studies
- Access to modern greenhouses (in the works)
Bioaccumulation / Fish Metabolism
Bioconcentration & Metabolism
Characterization of potential of chemical substances to bioconcentrate in aquatic species. We offer identification of metabolic pathway of substances in fish:
- GLP- & Non-GLP-conform studies following international guidelines (US-EPA OPPTS/OCSPP, OECD, SETAC, REACH etc.)
- 14C-tracer or non-radiolabeled studies, both at our analytical lab and our large in-life facility
- Evaluation of the potential uptake of test substance during exposure phase
- Assessment of the elimination of accumulated substances during post-exposure/depuration phase
- Identification of steady-state or kinetic bioconcentration factor for test substances and major metabolites
- Bioaccumulation studies with fish, crustacean, etc.
- Fish metabolism and fish feeding studies with cold and warm water species
- Total radioactive residue (TRR) determination in variety of fish tissues
- Fish lipid content determination
- In-life facility- Genesis Midwest, LLC to accommodate large bioaccumulation and fish metabolism studies utilizing static and semi-static designs