Across Barriers GmbH is a GLP, GMP certified and FDA approved contract research organization (CRO) in the field of preclinical product development (pharmaceutical, cosmetic products), safety evaluation of chemicals and in vitro bioequivalence of products.
Our services include the investigation and characterization of the pharmacokinetic parameters (ADME) of substances based on cell and tissue models (in vitro ADME).
Our In-Vitro absorption Models include:
• excised human skin and reconstructed skin models
• gastrointestinal (cell line: Caco-2, excised pig intestines)
• respiratory tract (cell lines: Calu-3, RPMI, A549, primary cells: pAEpC)
• ocular, nasal, buccal
• blood-brain barrier (primary cells, cell lines)
We also focus on the physicochemical characterization, (bio) analytics as well as toxicology and metabolism of substances. Furthermore, drug stability testing or studies of nano- and microparticles, which act as drug delivery systems, can be performed. In the field of chemical analytics we develop and validate bioanalytical methods (LC; LC-MS/MS; GC-FID) for in vitro studies as well as for biological materials like plasma, serum and various tissues.
A special interest of the company is the development and optimization of new vehicles on the basis of nanoparticles or new formulations with "nano-ized" active ingredients to increase the absorption of low soluble active ingredients.The methods for testing formulations (suspensions, semisolids, solid dosage forms, patches, and oral dispersible forms) like release testing, solubility of actives and stability are established.
In recent years, the company has successfully used the available In-Vitro systems as a substitute for clinical trials for the approval of generic products. The knowledge of the company helps to improve tremendously the preclinical characterization of any product without animal and human studies.
Across Barriers is experienced as partner in Research projects financed by EU (FP 6 and 7) and nationally financed projects (BMWi, BMBF, AiF). Within projects we offer our complete knowledge as described. Additionally we are interested in
• process improvement for In-Vitro studies
• improvement of In-Vitro models
• new formulations
• improvement equipment in terms of surface modification