News Article | September 19, 2017
Under the agreement, Absorption Systems will share available data on drug pharmacokinetics in dogs, as well as data from various specialized models used for predicting bioavailability, with the FDA's Center for Veterinary Medicine (CVM), the division of the agency that is tasked with approval of drugs for use in animals. Additionally, data from an in vivo model such as the Chronic Intestinal Access Port, which can be used for in vivo dissolution and to identify barriers to bioavailability, may be complemented with results generated with the patented In Vitro Dissolution and Absorption System (IDAS™) apparatus to augment the understanding of canine drug absorption considerations. FDA scientists, in turn, will incorporate the data into sophisticated computer models, which provide in silico simulations of the absorption, distribution, metabolism, and elimination of drugs in vivo. Because many of the tools that have been developed to model drug behavior in humans do not exist for dogs, the Absorption Systems data set will be particularly valuable in ongoing modeling and simulation projects. In fact, the expectation is that the ability to predict and confirm drug performance, as opposed to iterative evaluations for new drugs, will reduce the number of animals required in future testing. Sid Bhoopathy, Chief Operating Officer, commented that, "This collaboration exemplifies many of the things that drive us every day: scientific exchange, regulatory science, translational medicine, and ultimately, the development of better, safer drugs. We're looking forward to seeing where this leads us, down the road." Absorption Systems, founded in 1996, assists pharmaceutical, biotechnology and medical device companies in identifying and overcoming ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) barriers in the development of drugs, biologics and medical devices. The company's mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated human outcomes when they occur. IDAS2, a novel in vitro test system for simultaneous screening of drug absorption and dissolution, exemplifies Absorption Systems' commitment to innovation and is soon to be an industry standard for formulation assessment. Absorption Systems, with facilities near Philadelphia, PA, in San Diego, CA, and in Panama, serves customers throughout the world. For information on the company's comprehensive contract services, applied research programs, and proprietary test systems, please visit www.absorption.com.
News Article | September 27, 2017
At both the California and Pennsylvania sites, the company's footprint will grow by nearly 50%, with construction and outfitting of new laboratories and offices set for completion in September and October. New hires will increase headcount by approximately 20%. Absorption Systems recently branded its subsidiary, a dedicated cGMP (current Good Manufacturing Practice) testing facility for gene and cell therapy products, as ACF Bioservices™. The company's strength in gene and cell therapy has been heavily driven by customer demand for regulatory-compliant solutions over the past two to three years and is a natural outgrowth of the parent company's long-standing leadership in developing GLP (Good Laboratory Practice)-compliant in vitro cell-based models to predict the in vivo behaviour of therapeutics. Patrick Dentinger, President and CEO, commented that "This current expansion of the company is a result of a strategic plan for sustained incremental growth in a number of different growing areas, in particular our initiative into potency testing for gene and cell therapy products." About Absorption Systems Absorption Systems, founded in 1996, assists pharmaceutical, biotechnology and medical device companies in identifying and overcoming ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) barriers in the development of drugs, biologics and medical devices. The company's mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated human outcomes when they occur. IDAS2, a novel in vitro test system for simultaneous screening of drug absorption and dissolution, exemplifies Absorption Systems' commitment to innovation and is soon to be an industry standard for formulation assessment. Absorption Systems, with facilities near Philadelphia, PA, in San Diego, CA, and in Panama, serves customers throughout the world. For information on the company's comprehensive contract services, applied research programs, and proprietary test systems, please visit www.absorption.com. About ACF Bioservices ACF Bioservices (an Absorption Systems company) has the expertise and relevant experience needed to provide analytical support for gene and cell therapy products through every stage of development. Potency assays are on the critical path, and ACF offers de novo development, optimization, qualification, validation, and cGMP-compliant final product and product release testing services for both allogenic and autologous therapies. We have the capability to develop both in vitro and in vivo models to predict human outcomes and establish correlations between animal studies and in vitro cell-based assays. Our fully compliant facilities and studies have been inspected by the FDA, USDA, and AAALAC. ACF has over 20 years of business operating expertise developing proprietary assays, combining our skills in cell and molecular biology, assay development and validation, bioanalytical and immunochemical quantitation, statistical analysis, and regulatory affairs in a single-source collaboration. Please contact ACF Bioservices for additional information at acfbioservices.com.
Holve D.L.,Eye Care for Animals |
Mundwiler K.E.,Biological Test Center |
Pritt S.L.,Absorption Systems
Comparative Medicine | Year: 2011
Laboratory rabbits are commonly used for ocular drug and device studies. The purpose of this study was to determine the incidence of spontaneous ocular lesions in laboratory rabbits with respect to sex, breed, and supplier. We retrospectively evaluated ophthalmic examination records of rabbits screened between April 2008 and April 2010. These 1840 records represented 572 black Dutch belted (DB), 1022 New Zealand white (NZW), and 246 NZW x New Zealand red F1 crosses (WRF1). Rabbits were between 6 and 16 wk of age and had been received from 5 suppliers. Ocular structures evaluated were the cornea, lens, iris and vitreous with respect to sex, breed and supplier. A total of 177 rabbits (9.6%) and 233 eyes (6.3%) were effected. Of total rabbits, 15.3% males and 7.3% females were affected. The most common structure affected was the cornea in 5.7% of rabbits, (DB 11.7%, NZW 3.0%, and NZR 3.3%). The lens at 3.6% was second most common (DB 2.1%, NZW 4.6%, and NZR 3.3%). Both iris (0.2%) and vitreous (0.3%) were not significantly affected. Significant sex-breeder-supplier combinations were: cornea DB supplier D, supplier D females, supplier D males, DB males and NZR females; and lens: NZW females; and at least one affected ocular structure: NZW supplier D, supplier D females, DB males, NZW females, and NZR females. Breed, sex, and supplier were significant variables of ocular lesions in laboratory rabbits. Investigators should consider each of these variables when choosing rabbits for ocular studies. Copyright 2011 by the American Association for Laboratory Animal Science.
Mezine I.,Absorption Systems |
Bode C.,Absorption Systems |
Raughley B.,Absorption Systems |
Bhoopathy S.,Absorption Systems |
And 3 more authors.
Chemico-Biological Interactions | Year: 2013
Metabolites (including reactive metabolites) of troglitazone were generated by incubation with cryopreserved human hepatocytes and trapped in the presence of an exogenous mixture of unlabeled and stable isotope labeled (SIL: [1,2-13C, 15N]-glycine) glutathione (GSH/SIL-GSH). The incubation samples were analyzed using liquid chromatography-high resolution accurate mass spectrometry (LC-HRAMS) implemented on a LTQ Orbitrap mass spectrometer. The GSH conjugates of the reactive metabolites were detected via a characteristic mono-isotopic pattern (peaks separated by 3.0037 u). Analysis of the incubation samples led to detection of a number of previously described GSH conjugates, as well as two novel methylated GSH conjugates, which were partially characterized based on accurate mass measurements and MS/MS data. The addition of exogenous GSH led to an increase in the apparent level of detected GSH conjugates. Kinetic isotopic measurements showed that the rates of incorporation of exogenous GSH are conjugate-specific. In conclusion, this approach, based on the use of a mixture of GSH/SILGSH, allows facile capture and detection of reactive metabolites in human hepatocytes. Moreover, the data suggest that routine addition of glutathione to the assay medium may be advisable for experiments with cryopreserved hepatocytes. © 2013 Elsevier Ireland Ltd. All rights reserved.
Bode C.,Absorption Systems
Drug Discovery Today | Year: 2010
In vitro investigation of pharmacokinetic drug-drug interactions (DDIs) has officially been part of the regulatory pathway for new drugs in the USA since the publication of an FDA guidance on the subject in 1997. The field has continued to evolve, driven by preclinical and clinical experience, improved understanding of the molecular basis of DDIs, technological advances, and a continuous dialogue between the FDA and pharmaceutical industry scientists. Some striking DDIs involve multiple molecular species and targets; their mechanisms and magnitude would have been difficult or impossible to predict with available in vitro tools. This article focuses on one such example. © 2010 Elsevier Ltd.
News Article | November 21, 2016
EXTON, Pa., Nov. 21, 2016 /PRNewswire/ -- Absorption Systems, a world leader in novel test systems for drug transporters, announces the renewal of a technology licensing deal with Biogen. After years of contract testing by Absorption Systems using MDR1-MDCK cells, Biogen licensed the...
News Article | February 16, 2017
EXTON, Pa., Feb. 16, 2017 /PRNewswire/ -- Absorption Systems, a global leader in nonclinical testing of drugs, biologics, and medical devices, is pleased to announce that its Chief Operating Officer, Sid Bhoopathy, Ph.D., has been selected as a winner of the 2017 Executive Management...
News Article | November 11, 2016
EXTON, Pa., Nov. 11, 2016 /PRNewswire/ -- Absorption Systems, a global leader in the science of translational medicine, announces the issuance of a U.S. patent for its unique In Vitro Dissolution Absorption System (IDAS2™) technology, which enables the simultaneous evaluation of drug...
Miezeiewski B.,Absorption Systems |
McLaughlin A.,Absorption Systems
Methods in Pharmacology and Toxicology | Year: 2014
The hepatic transporters OATP1B1 and OATP1B3 contribute (to varying degrees, depending on the drug) to the uptake of many anionic drugs, including several of the widely used statins. Because statins are prescribed for many patients and the consequences of pharmacokinetic interactions with uptake inhibitors can be severe (even fatal), the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require that all NCEs be evaluated as inhibitors of OATP1B1 and OATP1B3. In addition, if hepatic clearance is expected to be a major pathway of elimination of an NCE, it must also be evaluated as a substrate of both transporters. Cell-based assays with over-expressing cell lines are useful for screening both substrates (based on uptake of the test compound) and inhibitors (based on interference with the uptake of a probe substrate by the test compound). The approach will be illustrated with real data, and subtle but important technical details will be discussed. © 2014 Springer Science+Business Media New York.
Wang Q.,Absorption Systems |
Sauerwald T.M.,Absorption Systems
Methods in Pharmacology and Toxicology | Year: 2014
P-glycoprotein (P-gp), the product of the human ABCB1 gene and often called MDR1, is the best understood membrane protein known to be involved in the active transport of drugs across biological membranes. In addition to mediating or limiting the absorption, distribution, excretion, and toxicity of many drugs, P-gp is the potential locus of a number of pharmacokinetic drug-drug interactions when two drugs, one a substrate and the other a substrate or inhibitor of the transporter, are co-administered. This last point is the reason for the interest of regulatory authorities around the world, several of which (most notably the U.S. FDA and the EMA) now require that all new molecular entities (NMEs) be evaluated as P-gp substrates and inhibitors. This chapter will cover model test systems, including in vitro assays for human P-gp such as cell-based (over-expressing and knockdown cells) and subcellular (membrane vesicle) approaches, as well as in vivo animal models. The chapter will conclude with examples of two cell-based systems, MDR1-MDCK (over-expressing) and Caco-2 (parental and P-gp knockdown cell lines). © 2014 Springer Science+Business Media New York.