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End-to-End Cell Therapy Automation

Biopharma international peer-reviewed case study paper on automation in autologous cell therapy (featuring cocoon).
Authors: James Morrissey, Yaling Shi, Nuala Trainor
Publish Date: 01-Sep-2017

Lipophilic Salts of Poorly Soluble Compounds To Enable High-Dose Lipidic SEDDS Formulations in Drug Discovery

Self-emulsifying drug delivery systems (SEDDS) have been used to improve the exposure of poorly water-soluble drugs in high-dose pharmacokinetic (PK) and toxicokinetic (TK) studies. However, the absorbable dose is often limited by drug solubility in the lipidic SEDDS vehicle. This study focuses on increasing solubility and drug loading of ionizable drugs in SEDDS vehicles using lipophilic counterions to prepare lipophilic salts of drugs. To learn more, please view our publication.
Authors: Dr. Michael Morgen, Dr. Ajay Saxena, Dr. Xue-Qing Chen, Warren Miller, Richard Nkansah, Dr. Aaron Goodwin, Dr. Jonathan Cape, Dr. Roy Haskell, Dr. Ching Su, Dr. Olafur Gudmundsson, Dr. Michael Hageman, Anoop Kumar, Gajendra Singh Chowan, Abhijith Rao, Vinay Holensarsipur
Publish Date: 01-Aug-2017

Magnetic Resonance Imaging Quantification of Fasted State Colonic Liquid Pockets in Healthy Humans

The rate and extent of drug dissolution and absorption from solid oral dosage forms depends strongly on the volume of liquid in the gastrointestinal (GI) tract. However, little is known about the time course of liquid volumes in the GI tract, particularly in the colon. This study used magnetic resonance imagining (MRI) to measure the time course of the number, regional location, and volume of pockets of freely mobile liquid in the undisturbed colon of 12 fasted humans after they drank a glass of water. To learn more, please view our paper.
Authors: Dr. Kathryn Murray, Dr. Caroline Hoad, Dr. Deanna Mudie, Dr. Jeff Wright, Dr. Khaled Heissam, Nichola Abrehart, Susan Pritchard, Salem Al Atwah, Dr. Penny Gowland, Dr. Martin Garnett, Dr. Gregory E. Amidon, Robin Spiller, Dr. Gordon Amidon, Dr. Luca Marciani
Publish Date: 24-Jun-2017

Impact of Drug-Rich Colloids of Itraconazole and HPMCAS on Membrane Flux in vitro and Oral Bioavailability in Rats

The oral absorption of poorly soluble drugs can be improved by formulating them as amorphous solid dispersions (ASDs). Upon dissolution, ASDs can reach higher concentrations of unbound drug than the crystalline drug form does, often generating many rapidly dissolving drug-rich colloids, which can decrease the diffusional resistance across the unstirred water layer of the intestinal tract. This publication describes a study of the impact of varying concentrations of drug-rich colloids on the oral absorption of itraconazole in rats and quantifies the colloids' impact on in vitro flux as a function of bile salt concentration. To learn more, please read our publication.
Authors: Dr. Aaron Stewart, Dr. Michael Grass, Timothy Brodeur, Dr. Aaron Goodwin, Dr. Michael Morgen, Dr. Dwayne Friesen, Dr. David Vodak
Publish Date: 07-Jun-2017

Development of a Biorelevant, Material-Sparing Membrane Flux Test for Rapid Screening of Bioavailability-Enhancing Drug Product Formulations

Bioavailability-enhancing formulations can overcome challenges of oral delivery of low-solubility compounds. However, conventional in vitro dissolution tests often do not accurately compare such formulations because of the many different drug species that may exist in solution. This paper describes a practical in vitro membrane flux test that requires minimal active compound and can be used to quickly compare performance of bioavailability-enhancing formulations. To learn more, please read our publication.
Authors: Dr. Aaron Stewart, Dr. Michael Grass, Dr. Deanna Mudie, Dr. Michael Morgen, Dr. Dwayne Friesen, Dr. David Vodak
Publish Date: 25-Apr-2017

Platform Approach for Inhaled Drug Delivery Products

This presentation reviews the use of a novel platform for the development of inhaled drug-delivery products.  This systematic methodology accounts for the myriad complexities during the development process, resulting in a customized formulation and process definition.  Encapsulation and drug-product options are reviewed, as are analytic considerations, producing a robust formulation and process suitable for clinical trials. To learn more, please view our presentation.
Authors: Devon DuBose, Dr. David Vodak, Dr. Michael Burke
Publish Date: 20-Apr-2017

Paper- A consensus introduction to serum replacements

ISCT peer-reviewed paper on serum replacements and serum-free media for cellular therapies.
Authors: Eytan Abraham
Publish Date: 01-Feb-2017

Bioreactors for cell therapies

ISCT peer-reviewed paper on Bioreactors for cell therapies.
Authors: Eytan Abraham
Publish Date: 01-Jan-2017

Spotlight on Product Characterization

Bioinsights sponsored inteview on analytical tools, assay development and characterization.
Authors: Behnam Ahmadian
Publish Date: 01-Dec-2016

A Newly Defined and Xeno-Free Culture Medium Supports

PLOS one Peer reviewed paper on medium replacement in the generation of hiPSCs.
Authors: Behnam Ahmandian and Thomas Fellner
Publish Date: 01-Sep-2016