Study design

using QbD, DoE and data analysis using statistical approaches

Multidisciplinary cooperation

with specialists from all over the world

Modern laboratories

equipped with high-class equipment to work with process and analytical methods

Creative team

consisting of several dozen specialists with university education and experience in biotechnology and related fields

We do know how

Our skills and capabilities allow us to accomplish tasks related to:

Step 1

Optimization of the vector structure encoding the sequence of the desired product

Step 2

Establishment and characterization of stable cell lines

Step 3

Process space determination and process characterization

Step 4

Development of processes to obtain fully active recombinant proteins, including modified proteins, at the laboratory scale using sterile cultures of various cell lines as well as protein purification techniques

Step 5

Implementation of analytical research panels such as the determination of the target quality profile of products (QTPP), bioequivalence and biosimilarity studies, stability studies of products under different storage conditions as well as under stress conditions, physicochemical, structural and biological characterization of proteins.

Step 6

Development, qualification and validation of methods for the determination of pharmacokinetics, pharmacodynamics, immunogenicity of biological drugs.

Step 7

Comprehensive design, implementation and monitoring of international, multi-center clinical trials.

Step 8

Preparation of registration dossiers and other regulatory documents pertaining to quality, process, clinical trials in the European Union. Regulatory oversight of research and development, manufacturing, analytical and clinical activities.


At each stage of our work we use guidelines from regulatory agencies (EMA, FDA), literature data, as well as modern approaches to experimental planning and data analysis, such as QbD (Quality by Design) or DoE (Design of Experiment).

The use of statistical software (including JMP and GraphPad) allows for reliable inferences based not only on observations but also on numerical data. A broad perspective on each project allows us to achieve success quickly and efficiently. We consult research plans with top class experts in biopharmaceutical and regulatory affairs.