BASIC During the basic research phase scientists are working to gain an in-depth understanding of a disease, the biological mechanism behind it and to identify potential compounds that might be targeted with a new drug.
DRUG Drug discovery is a wide definition of the work that takes place after the target has been identified. This work can include many types of projects but typically the focus is on target validation and lead optimization.
PRE-CLINICALOnce a drug candidate is selected, preclinical studies are performed to evaluate its safety, efficacy, and potential toxicity. Pre-clinical studies help the researchers to design the studies for the clinical trials and safety evaluation criteria are identified.
MANUFACTURINGThe chemistry, manufacturing and controls (CMC) process is pivotal in ensuring that drugs and treatments being manufactured are safe, effective and of a high quality for patients.
CLINICAL During the Clinical trials a drug is tested in humans for the first time. First in a population of healthy volunteers (phase I), then in a small patient population (phase II) and finally in a larger patient population (phase III).
POST MARKETPostmarketing surveillance refers to the process of monitoring the safety of drugs once they reach the market, after the successful completion of clinical trials. The primary purpose is to identify previously unrecognized adverse effects as well as positive effects.
At an early stage in the development process, thousands of compounds need to be narrowed down to a small number of the most promising candidates.
In order to identify the best candidates, you should use an assay that as closely as possible reflects the complex processes of the cell, where different proteins or pathways are induced or inhibited depending on the circumstances. It is not sufficient to just determine whether or not the compound binds to its intended target.
Our cell-based iLite assays offer this functionality. In addition to finding out if the candidate drug binds to it target, you get additional information that can help you determine if the compound functions according to its intended mechanism of action.
Determining the potency of a candidate is one of the most essential parts of drug development.
Based on the regulatory guidelines, the potency of the drug candidate often needs to be addressed by a cell-based assay to achieve the biological relevance required. Potency assays also need to be highly reproducible.
The iLite system fits both criteria and can be used for measuring the drug candidate’s potency for Quality Control and as a batch release assay. Typically, it has to be established that the drug gives the same potency (effectiveness) for each batch when tested in a biologically relevant setting,
iLite cell lines can be successfully used to:
Immunogenicity is an immune response against a therapeutic antigen causing that medication to lose its effectiveness over time and potentially resulting in serious illness. Clearly, immunogenicity is an important factor to consider as manufacturers develop new protein therapeutics.
Because drug development becomes increasingly costly as it moves downstream, it is important to anticipate immunogenicity as far upstream as possible in the drug discovery process.
Customers assessing immunogenicity need an Anti-Drug Antibody (ADA) assay and a NAb assay. While ADAs are most easily assessed by a regular ligand binding assay, detection of NAbs most often requires a functional cell-based assay.
Requirements for NAb assays are:
With many of the existing patents of monoclonal antibody block buster drugs set to expire in the next few years, the development of biologic therapeutics similar to the original drug (biosimilars) has become increasingly important.
However, extensive requirements for analytical characterization is needed to show comparability between innovator and biosimilars and it must be proven that “the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components” and that “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency”. This is the biosimilar development approach from the EMA, FDA and WHO.
The most critical evaluation is that of biological function, through assays that replicate the likely mechanism of action in vivo. Here, iLite Functional Bioassay Profiles could be of great value, when assessing and comparing the response of the compounds.
At an early stage in the development process, thousands of compounds need to be narrowed down to a small number of the most promising candidates.
In order to identify the best candidates, you should use an assay that as closely as possible reflects the complex processes of the cell, where different proteins or pathways are induced or inhibited depending on the circumstances. It is not sufficient to just determine whether or not the compound binds to its intended target.
Our cell-based iLite assays offer this functionality. In addition to finding out if the candidate drug binds to it target, you get additional information that can help you determine if the compound functions according to its intended mechanism of action.
Determining the potency of a candidate is one of the most essential parts of drug development.
Based on the regulatory guidelines, the potency of the drug candidate often needs to be addressed by a cell-based assay to achieve the biological relevance required. Potency assays also need to be highly reproducible.
The iLite system fits both criteria and can be used for measuring the drug candidate’s potency for Quality Control and as a batch release assay. Typically, it has to be established that the drug gives the same potency (effectiveness) for each batch when tested in a biologically relevant setting,
iLite cell lines can be successfully used to:
Immunogenicity is an immune response against a therapeutic antigen causing that medication to lose its effectiveness over time and potentially resulting in serious illness. Clearly, immunogenicity is an important factor to consider as manufacturers develop new protein therapeutics.
Because drug development becomes increasingly costly as it moves downstream, it is important to anticipate immunogenicity as far upstream as possible in the drug discovery process.
Customers assessing immunogenicity need an Anti-Drug Antibody (ADA) assay and a NAb assay. While ADAs are most easily assessed by a regular ligand binding assay, detection of NAbs most often requires a functional cell-based assay.
Requirements for NAb assays are:
With many of the existing patents of monoclonal antibody block buster drugs set to expire in the next few years, the development of biologic therapeutics similar to the original drug (biosimilars) has become increasingly important.
However, extensive requirements for analytical characterization is needed to show comparability between innovator and biosimilars and it must be proven that “the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components” and that “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency”. This is the biosimilar development approach from the EMA, FDA and WHO.
The most critical evaluation is that of biological function, through assays that replicate the likely mechanism of action in vivo. Here, iLite Functional Bioassay Profiles could be of great value, when assessing and comparing the response of the compounds.