Method development and validation

Method development and validation

Our services cover analytical and bioanalytical methods development and validation as well as qualification of pharmacopoeial methods and customers methods. Optimization for obtaining favourable characteristic is carried out during the method development stage.

To provide customers with flexibility we set the scope of the validation with the acceptance criteria individually to a customer’s needs. Method validation is in compliance with the recommendations of the International Conference on Harmonization (ICH), the requirements of the European Medicines Agency (EMA) and the U.S. Agency for Food and Drug Administration (FDA). After validation task is completed, a customer receives a validation report. We offer preparation of registration documents in CTD format. We also provide methods transfer services to an external laboratory, as well as we transfer customer’s methods to the BLIRT laboratory.

BLIRT offers development and validation of  methods to assess the identity, content and purity of the products. With the experience of employees and modern equipment of the Analytical Department, it is possible to choose an appropriate analytical technique for a wide range of substances. There is also the possibility of scaling up the process of chromatography to separate the fraction of interest and lower limit of quantification. The Analytical Department laboratory is well equipped with apparatuses – list of equipment.

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has adopted Impurities Guidelines for Residual Solvents which prescribes limits for the content of solvents which may remain in active substances, excipients and medical products after processing. The guideline recommends the use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents. All substances and products are to be tested for the content of solvents likely to be present in a substance or product.

BLIRT offers a determination of the residual solvents using headspace gas chromatography with a flame-ionization detector, in accordance with the guidelines of the ICH and the European Pharmacopoeia (PH. Eur. 7.0).

BLIRT develops and validates methods suitable for evaluation of the effectiveness of cleaning after washing the production equipment. The methods are designed to confirm the safety, effectiveness, repeatability of the equipment washing procedures routinely used in our customers’ factories and to confirm that there is no risk to the quality of the product. In addition, we provide research on swab sample storage conditions after collection including the effects of parameters such as storage lighting and temperature.

Examination of the stability of medicinal products allows to assess the quality in a long term. The Analytical Department offers stability studies in validated climatic chambers under the standard conditions of 25°C/60% RH, the intermediate conditions 30°C/65% RH and the accelerated conditions 40°C/75% RH. The conditions in climatic chambers are controlled and monitored round the clock.

  • MSDetermination of drug concentrations in biological samples is a very important aspect of drug development, and therefore the reliability of the analytical methods is crucial. Bioanalytical method validation confirms the reliability and reproducibility of the determined concentration of drug or metabolite in biological material. BLIRT company offers development and validation of analytical methods in compliance with requirements of EMA or FDA guidelines. Bioanalytical methods are developed based on ultraperformance liquid chromatography coupled with tandem mass spectrometry (UHPLC-MS/MS).
  • ELISA testEnzyme-linked immunosorbent assay – ELISA – solid-phase plate enzyme immunoassay is one of the most widely used tests in the scientific and diagnostic biomedical immunoassay. Its purpose is to detect and estimate the concentration of the protein by using the appropriate antibodies – monoclonal or polyclonal antibodies. ELISA is based on formation of immune complexes of antigen-antibody conjugate which enables the detection of the enzymatic reaction.ELISA tests have a high sensitivity, specificity, reproducibility, and short execution time.

    BLIRT offers performance commercial ELISA (read UV-VIS, fluorescence and luminescence), as well as advice on choosing the appropriate test, taking into account the test matrix and the required sensitivity range.