Backed by extensive experience in biotherapeutic bioanalysis, Inotiv offers the preclinical and clinical research support our biopharma partners need throughout all phases of method development and validation. We pride ourselves on our history of providing expert insights and reputable data to world leaders in drug development. To provide our clients with a full spectrum of bioanalytical and biomarker assays, from discovery to Phase IV clinical studies, we have established a strategic collaboration with Synexa Life Sciences, a leading clinical sample analysis laboratory who specialize in bioanalysis and the areas below.

We have decades of experience developing and implementing optimal biomarker strategies, generating insights that will improve the quality of your decision making at each stage of your therapeutic’s development. Read more about our biomarker strategies here.

At Inotiv, we have learned that thorough assay development, optimization, and validation is best done well in advance of planned studies, as the process can deliver significant improvements in assay sensitivity and overall robustness, with implications for sample volume and sample preparation methods. Our scientists have proven expertise in customizing assays for method development and validation that satisfy regulatory requirements and deliver high-quality, robust, and reproducible data.

Method Development

The purpose of method development is to define and test method design under a variety of conditions before subjecting it to validation, optimizing basic assay parameters prior to method validation. Inotiv’s method development parameters include:

  • Assay platform
  • Suitable reference standard
  • Quality controls
  • Matrix type
  • Minimum required dilution
  • Assay quantification range
  • Sample collection processes
  • Storage conditions
  • Incubation temperatures and duration
  • Capture and detection of molecule pairs
  • Concentrations and number of wash cycles
  • And more

Validation

Following method development, bioanalytical method validation demonstrates that the optimized method is suitable for the intended analysis of study samples. Inotiv performs method validation in accordance with all FDA and EMA guidelines, and will work with you to define and plan the appropriate extent of method validation (custom or full validation) for your study.

Advances in new biologics give hope for better treatments for complex diseases. However, the full promise of these treatments cannot come to fruition without accurate, reliable, and compliant methods of analysis to guide their development. Inotiv is committed to bringing our vast experience in the development of customized assays for novel biotherapeutics to bear on this challenge, and we are actively involved in developing and validating assays for novel biotherapeutic modalities.

For clinical analysis, we are pioneering the field of analysis of exosomes and extracellular vesicles (EVs) using microparticle-detecting flow cytometry, and we are at the forefront of developing bioanalytical strategies for checkpoint inhibitor development. We are also working to amass the same expertise in the preclinical field.

Exosomes

Growing evidence implicates microparticles as prominent mediators of neurodegenerative diseases, such as Parkinson’s disease, making them an attractive therapeutic modality to be explored. Inotiv is working to develop flow cytometric microparticle analysis to analyze microparticles in CSF for stratification of Parkinson’s and other neurological diseases.

Immune Checkpoint Inhibitors

The development of immune checkpoint inhibitors (ICIs) targeting lymphoid cells has revolutionized therapeutic approaches for the treatment of cancer. To support the continued benefits of this line of research, Inotiv has established flow cytometry panels to characterize circulating immune cell subsets and determine their effects on ICI therapies.

As new therapies are developed, it is necessary for innovative technologies and bioanalytical strategies to be adopted to assess each therapeutic and its treatment potential in an accurate and consistent way. Inotiv is at the forefront of developing and implementing these strategies in key therapeutic areas and niche treatment approaches.

Cell and Gene Therapies

Our clinical team of scientists commands a wide range of experience in cell and gene therapies, enabling us to provide integral guidance for your study. Depending on your specific requirements, we can either select the right assays for your gene or cell therapy product from among our bioanalytical service offerings, or work with you to develop novel assays to suit your needs.

Vaccines

Our experience and understanding of the science of immunobiology underpinning health and disease empower us to provide expert guidance supporting vaccine development across a wide array of therapeutic areas, including COVID-19.

Biosimilars

Biosimilars are a fast-growing sector within the pharmaceutical industry. Our record of success in the clinical field makes us well suited to provide high-quality, deeply informative, and relevant bioanalytical expertise to facilitate your therapeutic’s development.