PortaCellTec biosciences GmbH

PortaCellTec – the pathfinder for your drug

Transporters are membrane proteins whose primary function is to facilitate the flux of molecules, like nutrients or endogenous substrates (e.g. sugar, amino acids, nucleotides) into and out of cells.
However, the specificity of these transporters is not strictly restricted to these physiological substrates. Drugs that bear significantly structural similarity to the physiological substrates have the potential to be recognized and transported by these transporters.
Consequently, these transporters play key roles in determining the bioavailability, therapeutic efficacy, and pharmacokinetics of a variety of drugs.
According to FDA/EMA guidelines (see below) PortaCellTec biosciences provide transporter assays, to proof the interaction of drugs and their metabolites with selected cellular transporter proteins, which facilitate the flux of molecules into cells (SLC transporters) and out of the cells (ABC transporters).

Guidance for Industry

EMA - Guideline on the Investigation of Drug Interaction (2012)

The International Transporter Consortium - Membrane transporters in drug development: the full report from the International Transporter Consortium, March 2010, is available from Nature Reviews

EMA - Guideline on the Investigation of Drug Interaction (Draft Guidance2010)

Major human transporters (FDA) 2006

FDA - Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labling
(draft guidance for industry 2006)


In 2010 the International Transporter Consortium (ITC) published a review titled Membrane transporters in drug development in which is defined which transporters are clinically relevant and have to be investigated under drug development. In the same year the EMA published a guideline for investigation of clinically relevant transporters. These relevant transporters are listed in the following table.

Transporter
ITC/FDA EMA
OCT1   +
OCT2 + +
OAT1 + +
OAT3 + +
OATP1B1 + +
OATP1B3 + +
MDR1 (P-gp) + +
BCRP + +
BSEP   +


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PortaCellTec Biosciences GmbH

 

Weender Landstraße 94 -108
37075 Göttingen
Tel : +49 551 309 66440
E-mail: PortaCellTec



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PortaCellTec

News

New validated products:

  • MRP2
  • roct1

Events

2nd German Pharm-Tox Summit
Heidelberg, Germany
March 06-09, 2017

19th Barrier- and
Transporter-Meeting

Bad Herrenalb, Germany
May 15-17, 2017

14th European ISSX Meeting
Köln, Germany

June 26- 29, 2017

2nd Symposium on Transporters in Drug Discovery
London, UK
May 15-16, 2017



Münster Transporttage 2017
Münster, Germany
October 21 – 22, 2017

 


Guidance for Industry (FDA and EMA)

Publications