Absorption Systems is a full service nonclinical CRO developing innovative services and solutions for the pharmaceutical, biotech, medical device and regenerative medicine industry. Our services include research and testing for small molecules, large molecules, biologics, medical device and cell and gene therapy products. The company's mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated outcomes when they occur. The company's facilities are strategically located in Philadelphia, San Diego, Boston and Panama, servicing hundreds of customers throughout the world. Our focus is to maintain accuracy, timelines, and reliability at every stage of development. For more information on the company's comprehensive contract services and applied research programs, please visit absorption.com.
Our formulations team can help identify and prepare dose vehicles that are appropriate for short or long-term toxicology studies. Dosing and observations are handled by our expert staff with more than a decade’s experience in small and large animal studies (acute, subchronic, chronic, dose range finding, etc). Our in-house bioanlaytical capabilities (both non-GLP and GLP) enable us to oversee your project from beginning to end.
Direct / Indirect Ophthalmoscopy
Optical Coherence Tomography (OCT)
Indocyanine Green (ICG)
Electroretinography (ERG, mfERG), VEP
Cell Culture Room
Absorption Systems offers a wide range of in vivo preclinical medical device testing services at our San Diego facility. Our goal is helping our clients attain successful 510(k) or PMA submissions. Our USDA-registered and NIH-assured, AAALAC-accredited GLP facility is also available for contract vivarium leasing and physician training sessions.
Overview of Services
In vivo, GLP and non-GLP
Safety and Efficacy
Physician Training & Cadaver Studies
You can benefit from Absorption Systems’ integrated services for toxicology support. Preclinical toxicology and related safety studies are a pivotal part of the drug development life cycle, as they are needed to demonstrate that the test compound is safe, and at what doses, for administration to humans as part of clinical trials.
Dosing and observations are handled by our expert staff with more than a decade’s experience in small and large animal studies (acute, subchronic, chronic, dose range finding, etc). Our in-house bioanlaytical capabilities (both non-GLP and GLP) enable us to oversee your project from beginning to end.
Dose Vehicle Development & Evaluation:
We offer various surgically ported animal models to help with formulation assessment in addition to the standard rodent, canine and non-human primate models for oral and intravenous dosing. These include rats, dogs, and mini-pigs fitted with intestinal cannulas implanted at various sites for dosing solutions or suspensions, as well as dogs fitted with duodenal fistulas for dosing solids, semi-solids, capsules, and tablets directly into the duodenum. Several of these animal models are available routinely and other custom models can be prepared in line with customer needs.
We incubate the test article, at either a single concentration or 7 concentrations, with a selective probe substrate and human liver microsomes. We monitor a specific metabolite and compare its rate of appearance with that of a solvent control to assess the extent of inhibition of a given CYP by each concentration of a test article. An IC50 can be determined when 7 concentrations are assessed. For reversible inhibition, an IC50 ≤ the plasma Cmax translates to a likely clinical DDI.
Time-dependent inhibition (TDI) is evaluated by quantifying the IC50 shift after pre-incubation of test article with liver microsomes +/- NADPH. Clinical correlation for a positive TDI score can then be determined by a follow-up in vitro measurement of KI and kinact. Comparison of KI and kinact to plasma Cmax can predict potential clinical DDIs due to TDI.
We can perform isolation of a targeted metabolite from various in vitro and in vivo matrices followed by unambiguous structural elucidation using NMR. If isolation of metabolites is not feasible from biological matrices, we offer a complimentary approach – biomimetic oxidation.
Plasma protein binding is critical in the early phases of drug development to determine the amount of a drug available for distribution throughout various organs and tissues in the body. In addition, these in vitro tests can predict the extent to which the drug will be bound to plasma proteins in vivo.
We offer an extensive range of preclinical animal models for drug discovery and development, both at its own sites and through access to preferred providers.
Pre-approved protocols for:
The In Vitro Dissolution Absorption System (IDASTM) combines traditional dissolution testing with a means to determine and quantify interactions with a bio-relevant membrane. IDAS provides the ability to evaluate absorption, permeation, accumulation, biomarker regulation and metabolism, as well as the ability to test a finished dosage form from a tablet, capsule to suspension. The characterized and validated system allows for multiple dissolution media and drug products from all BCS classes.
Evaluate Formulations – Bioequivalence, Post Approval Changes, 505(b)(2) Formulations
Evaluate Food Effects
Evaluate Locally Acting GI Products
Cyp Induction (1A2,2B6,3A4) EA409
Freshly isolated or cryopreserved hepatocytes are incubated with test article for 3 days.
Enzyme activity approach: Hepatocytes are then incubated with a selective probe substrate. Appearance of metabolite is compared to that of a control treatment (no test article) via LC-MS/MS in order to assess the ability of the test article to induce a given CYP’s activity.
mRNA approach: mRNA is then isolated from the hepatocytes. cDNA is synthesized and used for qPCR to measure fold induction of CYP-specific mRNA. Comparison of treated cells to a control treatment (no test article) gives the article’s CYP induction potential.
Waters Xevo TQ-S
Thermo Scientific LTQ Orbitrap XL
AB Sciex 4000 QTRAP
AB Sciex API 4000
Waters Acquity UPLC
Leap CTC Analytics Autosamplers
Tomtec Quadra 96 robotic sample prep workstation
Conventional HPLC with UV detection
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