Analytical method development and validation

Analytical method development and validation

It is important to select an appropriate analytical method to fit the characteristics of the objective compound and to meet the aim of the determination.
It is necessary to start preparation in advance of determination, and check whether the method is provided with sufficient analytical ability. In some cases, it is required to optimize the analytical ability step by step in accordance with the development stage of the objective product (such as pharmaceuticals).
Mediford Corporation offers a series of services from consultation of analytical methods in the early stage, contract of method development followed by optimization and validation, to determination of actual samples.

Service details

Development of a novel analytical method

Mediford Corporation is entrusted with the development of various analytical methods such as determination of concentrations of a developing drug and its metabolites, determination of concentration or activity of biomarkers like cytokines and hormones, and evaluation of anti-drug antibodies against the administered drug.
The researchers in charge of the development are well trained in classical and the latest methods, mainly LC-MS/MS or Ligand-Binding Assay (LBA). We offer various kinds of analytical platforms. Please feel free to consult with us for more details.

Analytical method validation

A validation of the analytical method is conducted to prove that the method is adequate for its intended purpose. The analytical method for pharmaceutical development is evaluated with the necessary test items in accordance with the guidelines issued by PMDA/MHLW, ICH, FDA, EMA, etc. We have multiple GLP accredited laboratories and have a long track record of meeting domestic and international requirements.
In the early stage of development or in the screening stage of candidate compounds, we may conduct a validation at the appropriate level for the stage. We can select and propose appropriate validation test items based on a “fit-for-purpose" strategy.

Analytical method transfer and optimization

We support method transfer from the sponsor and domestic and international analytical laboratories. Even if the same equipment is not available, we can offer the same level of performance through optimization of the analytical conditions. If necessary, we also offer inter-facility validation.
If existing analytical methods lack performance in sensitivity or specificity, we offer consultation for improvement of analytical methods. Through our hard and long earned knowledge and experience, we can provide solutions to our clients’ various challenges.

Establishment of evaluation methods utilizing commercial kits

For easier and quicker analysis, it is effective to utilize commercial products such as ELISA kits.
However, it is often found that the candidate product is not accompanied with sufficient data to judge whether it provides appropriate performance to meet the objective of the analysis. And if multiple candidate products are available, it is necessary to select the most appropriate one.
Mediford Corporation can streamline the selection process by proposing evaluation items in accordance with the needs of the client. Of course, we also provide full validation services.

Antibody preparation and labelling

In the establishment of an analytical method, besides standard substances, it is sometimes necessary to prepare other critical reagents such as antibodies to objective compounds or labeled antibodies. In addition, antibodies are required as a positive control in the method to determine anti-drug antibodies.
Mediford Corporation can prepare polyclonal/monoclonal antibodies necessary for such method establishment as well as purify/label the prepared antibodies.

Antibody preparation/bulk producing

  • Monoclonal antibody: determination of immunity and antibody titer, cell fusion and cloning, establishment of hybridoma, culture supernatant, etc.
  • Polyclonal antibody: synthesis and purification of immune antigen, conjugate of antigen, immunization of animals, determination of antibody titer, etc.

Antibody purification/modification/labelling

  • Purification: Protein A, ammonium sulfate fractionation, ion exchange chromatography
  • Fragment preparation: F(ab’)2, Fab’
  • Labelling: HRP, ALP, fluorescent pigment, Biotin, SULFO-TAG, etc.