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In vitro Characterization of Nanomedicines

Phalloidin and DAPI staining of human pigmented epithelial cells (ARPE cells)
Phalloidin and DAPI staining of human pigmented epithelial cells (ARPE cells).

Accelerate your nanomedicine’s journey to market with NANBIOSIS: tailored in vitro characterization services ensuring preclinical validation success, saving crucial time in the development process.

Scientific Leaders of the project: Ibane Abasolo, José Luis Pedraz, & Ramón Mangues.
Coordinator of the project: Ibane Abasolo & Esther López

Industrial problem/gap covered

One of the causes that increases the time required to reach the market in nanotherapeutics is the preclinical validation. For this to be successful, the nanomaterials needs to be tested under controlled conditions, such as in vitro, prior to start their in vivo testing. This is a crucial step since the standard protocols used for more traditional drugs are not applicable in the case of nanomedicines. NANBIOSIS offers a complete study plan tailored to meet the demands of each nanomedicine product, from the properties of the materials all the way to their preclinical validation. This plan is developed in collaboration with the user and starting from a set of basic analytical tests to more sophisticated experiments.

Description

We offer a complete in vitro Characterization. e.g., immunology, cytotoxicity, hematology, oxidative stress, etc., and more adapted to the different products by using the most sophisticated equipment and taking advantage of the expertise of scientist internationally recognized in the matter.

Some examples are described in the following publications:

Services involved:

Sterility Gel-Clot LAL Assay U20
Detection of Microbial Contamination U20
Detection of Bacterial Contamination U20
Detection of Mycoplasma Contamination U20
Immunology Analysis of Hemolytic Properties of Nanoparticles U20
Analysis of Platelet Aggregation by Cell Counting U20
Analysis of Platelet Aggregation by Light Transmission Aggregometry U20
Analysis of Nanoparticle Interaction with Plasma Proteins by 2D PAGE U20
Leukocyte Pro life ration Assay U14
Detection of Nitric Oxide Production by RAW 264. 7 MacrophageCell Line U18
ChemotaxisAssay U18
PhagocytosisAssay U18
Analysis of Cytokines, Chemokines and Interferons (by Elisa or Multiplex) IL-8, IL-1b, TNF-α, IFN- ϒ and many others U14
Determination of cytokine concentration by flow cytometry U14
Measurement of Nanoparticle Effects on Cytotoxic Activity of NK Cells by Label-Free RT-CES System U14
In vitro Induction of Leukocyte Procoagulant Activity by Nanoparticles U20
Oxidative Stress Hep G2 Hepatocyte Glutathione Assay U20
Hep G2 Hepatocyte Lipid Peroxidation Assay U20
HepatocytePrimary ROS Assay U20
Cytotoxicity (necrosis) Cytotoxicity (necrosis) Assay (MTT and LDH Release): LLC-PK1 Kidney, Hep G2 Hepatocarcinoma, etc U10, U18 & U20
Cytotoxicity (apoptosis) Cytotoxicity (apoptosis) (Caspase 3 Activation) LLC-PK1 Kidney; Hep G2 Hepatocarcinoma ; etc U10 & U18
Cytotoxicity (apoptosis) (Caspase 3/7 Activation) Hep G2 Hepatocarcinoma ; etc U10 & U18
Autophagy Autophagic Dysfunction Assay: Qualitative Analysis of MAP LC3I to LC3-II Conversion by Western Blot U18
Autophagic Dysfunction in LLC-PK1 Cells U18
Immunology Lymphocyte proliferation U14
Detection of Antibodies (anti PEG and others) U2
Cell uptake By cytometry U14, U18 & U20
By Confocal Microscopy U2
Of metallic NPs/Fe-staining U20
Optical Analysis: HR Dark-Field optical microscope with spectral analysis(Nano-scale Optical Microscope) U12

Effect of NP son cell viability and distribution in the cell cycle.

Elisa plate.

Phalloidin and DAPI staining of human pigmented epithelial cells (ARPE cells).

CAbS (U2) is managed by the scientific team of the Nb4D group (Nb4D) with high expertise in hapten synthesis, conjugation and antibody production.We have an extensive track record of successful projects in developing polyclonal and monoclonal antibodies against small molecules and peptidesfor the development of diagnostic tools. These include, for example, the evaluation of carcinogenic processes, cardiovascular diseases, and infectious diseases.

Located at the Faculty of Pharmacy, University of the Basque Country (UPV/EHU), Campus of Alava in Vitoria. Our Unit 10 is led by Prof. José Luis Pedraz and consists of large laboratories for cell culture, chromatography equipment, sample preparation and characterization, and one specific for scale preparation of pharmaceutical formulations. Recently the group has incorporated 3D bioprinters of the last generation with different technologies based on extrusion, inkjet, among others. It has also incorporated self-assembly equipment of nanoparticles based on microfluidic technologies.

This Unit can design and evaluate dosage forms both classical and new dosage forms of biotech drugs, DNA, RNA, and vaccines using different methodologies based on micro and nano-medicine and the latter technology based on the microencapsulation of cells, peptides, proteins, and in general of biotech products, as well as the development and design of non-viral vectors for gene therapy, is one of the biggest singularities of this Unit. It counts on the most advanced equipment for micro and nanoencapsulation.

The Unit aims to determine experimentally all the variables needed to develop an optimal formulation and work instructions for preparing final pharmaceutical products.

The pharmaceutical technology applied to drug development involves the selection of materials and procedures that can be adapted to different processes that lead to specific pharmaceutical forms. To do that, the Unit10 counts with the most advanced equipment to cover the development for all the steps of the process.

One of the singularities of this Units is that is GLP certified by the Spanish Medicament Agency

Our Unit 14 consists of a laboratory with an area of 81,02 m2 for cell biology and molecular biology techniques. The laboratory is also equipped with two cell culture rooms for the isolation, expansion and characterization of different cell types.

Unit 18 (Nanotoxicology) is located in the Hospital de la Santa Creu i Sant Pau, in Barcelona, and is coordinated by Dr. Ramón Mangues, PI of the Oncogenesis and Antitumor Drug Group. The main objective of the Nanotoxicology Unit is to assess the toxicity of new drugs, nanoparticles or nanotechnology-based biomaterials in in vitro and in vivo systems, with the goal of optimizing lead compounds and identifying those with the highest probability of success in the preclinical programme due to their greater safety and tolerability or reduced toxicity. The Unit has rooms equipped for cell culture, for cryopreservation of samples and cell lines, and for sample preparation and analysis and animal facilities for in vivo experimentation.

Equipment: The Unit has access to flow cytometers, sorters, confocal microscope and other equipment of the Platforms available at the Hospital Research Institute as well as housing facilities for small rodents (rat and mouse).

Located at the Valld’Hebron Research Institute (VHIR) in Barcelona, our In vivo Experimental Platform (U20) has three different sections, a Molecular Imaging section for in vivoex vivo and in vitro imaging studies (fluorescence, bioluminescence and X-rays), a preclinical animal model section and a preclinical histology section. All three sections are included within the Functional Validation & Preclinical Research (FVPR) of CIBBIM-Nanomedicine.

This Unit can design and evaluate dosage forms both classical and new dosage forms of biotech drugs, DNA, RNA, and vaccines using different methodologies based on micro and nano-medicine and the latter technology based on the microencapsulation of cells, peptides, proteins, and in general of biotech products, as well as the development and design of non-viral vectors for gene therapy, is one of the biggest singularities of this Unit. It counts on the most advanced equipment for micro and nanoencapsulation.

The Unit aims to determine experimentally all the variables needed to develop an optimal formulation and work instructions for preparing final pharmaceutical products.

The pharmaceutical technology applied to drug development involves the selection of materials and procedures that can be adapted to different processes that lead to specific pharmaceutical forms. To do that, the Unit10 counts with the most advanced equipment to cover the development for all the steps of the process.

One of the singularities of this Units is that is GLP certified by the Spanish Medicament Agency