We offer comprehensive services for biologics analysis, including protein and peptide characterization, bioanalytical method validation, and method transfers. Our support for preclinical and clinical studies includes PK/PD calculations and immunogenicity assays. We handle testing for a wide array of biological drugs. As a GLP-certified and GCP-compliant CRO, we excel in method transfer, validations, and development.

Biologics Analysis

Our biopharmaceutical analysis department offers comprehensive services for biologics analysis, including:

  • Protein and Peptide Characterization: Detailed analysis and profiling.

  • Bioanalytical Method Validation: Ensuring methods are validated in a GxP environment.

  • Method Transfers and QC: Seamless method transfers and rigorous quality control.

  • Output Testing: Selected testing in accordance with ICH-Q6B recommendations.

  • Preclinical and Clinical Study Support: Determination of high molecular weight drugs in biological matrices, testing of immunogenicity assays (total ADA), statistical evaluation of pharmacokinetic (PK) parameters, and bioequivalence assessments.

At Quinta – Analytica, we emphasize centralized project management. Each partner is assigned a dedicated project manager with experience in complex projects. These managers are supported by our department heads, who bring a wealth of practical expertise and robust theoretical knowledge.

Our facility is equipped with a diverse range of analytical instruments for biologics analysis, such as ELISA, ECLA, SPR, NGS, PCR, and UHPLC-MS/MS. This allows us to conduct comprehensive testing for starting materials, drug substances, intermediates, and final products of biologics. We offer bioanalytical services for a wide array of biological drugs, including innovative proteins, biosimilars, antibody drug conjugates (ADC), therapeutic peptides, enzymes, biomarkers, monoclonal antibodies, hormones, and oligonucleotides.

As a GLP-certified and GCP-compliant Contract Research Organization (CRO), we excel in method transfer, method validations, and the development of bioanalytical methods. Our team is ready to support PK/PD bioanalytic including calculations and immunogenicity assays, including Anti-Drug Antibodies (ADAs) binding as well.

For more details on specific analyses, explore the menu on the left, or contact us at

Quinta – Analytica’s capabilities extend beyond large molecule analysis. We handle complex projects across various domains of the pharmaceutical industry, including small molecule analysis, analytical R&D, bioanalytical testing, and clinical studies. Our comprehensive services ensure we meet the diverse needs of our clients, providing high-quality solutions for every stage of drug development.

Do you need any other services in the pharmaceutical industry such as formulation, manufacturing or batch release? Take a look at the solutions provided within our Conscio Group.

Characterization and protein purity

Based on the ICH-Q6B regulations, it is recommended to characterize proteins and peptides by their appearance, molecular weight, isoelectric point, pH in a solution, content of amino acids, primary structure and position of disulfide bridges. Purity analysis is a very important part of a complex characterization of active ingredients on protein or peptide bases. The above-limit presence of protein aggregates, residual nucleic acids or bacterial endotoxins can cause undesired and potentially life-threatening immune reaction in the human body.

Immunochemical properties

The evaluation of immunochemical properties of a given protein medicinal product becomes a necessity, especially if this medicinal product belongs to the category of antibodies. In such cases, characterization of drug affinity to specific antigens or their well-defined portions is required. Another integral part of characterization is testing of the immune response and the rate of ADA production (anti-drug antibodies).


Amino acids can be relatively easily modified chemically and proteins therefore often contain a number of post-translational modifications (PTMs). These modifications cannot be usually predicted from the gene encoding sequence, but because they have a significant influence on the overall protein functionality, their description is an essential part of a complex characterization of biological drugs.

Proteomic services

We offer identification of proteins and peptides in mixtures (e.g. plant and animal extracts, multi-component biopharmaceutical preparations) using 2D LC-MS/MS.

Quantification in biological material

In addition to the basic characterization of peptide and protein drugs, we also perform determination of these substances in biological material using the LC-MS and ELISA methods under good laboratory and clinical practices. Our laboratory is equipped with UPLC, LC-FTMS, ELISA systems (UV-VIS, fluorescence, electrochemiluminescence), capillary electrophoresis, gel electrophoresis, isoelectric focusing and automatic amino acid analysis.

Plasma protein binding using equilibrium dialysis

QUINTA-ANALYTICA uses plasma protein equilibrium dialysis and LC-MS / MS to determine this critical binding for its partners.

The highly effective equilibrium method sees Quinta use a device which has two chambers connected by a membrane with pores that allow only molecules up to a certain size to pass through it. A sample of plasma or protein with analyte is then pipetted into one chamber, and a buffer is placed into the other.

Once the equilibrium has stabilized, due to the free movement of small molecules and ions across the membrane, its concentration in both chambers is then measured and corresponds directly to the amount of substance which is unbound to the proteins.

For drug development it is critical to fully understand and measure this degree of protein binding of small molecules as it directly affects the rate of excretion of the preparation, in some cases, that can be as much as 95 – 99%, and in-turn, determines the drugs overall efficacy.

Additional Services


Proudly based in Central Europe, with partners in the EU, US and Asia, Quinta has 250 experienced in-house professionals ready to support your projects.


Based on isotopically labeled standards, our customizable in-house detection methods are available immediately.


Oversight of participant health and correctness of treatments during clinical studies.


Monitoring of daily routine to detect unrecognized adverse events, plus assess and ensure drug safety.


Thorough dossier M3 data audit to ensure consistency and compliance with regulatory requirements.


As an EU based company we are well-placed to help create & develop your IMPD.


It’s not an exhaustive list so if you don’t see what you need, contact us.


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+420 242 454 311

    For general and business contact only. To register as a volunteer for clinical studies (CZ nationals only) or speak with our clinical department, please visit here.