Our Analytical Development group provides dedicated services and support to customers for all phases of drug development. All work is performed to cGMP and ICH guidelines.
Our Analytical Development services include:
- API Characterization
- Preformulation
- Analytical test method development
- Validation
- Stability Testing
- Release Testing
- Reference material qualification and characterization
- Trace level method development and validation for low level potentially genotoxic impurities
Formulation Support and Prototype Stability
At Aptuit, our analytical groups work very closely with the formulation development team to provide fast and flexible support during the drug product development process. In addition to providing data, we work in cross-functional project teams to advise on testing strategy and assist with data interpretation to provide our clients with an integrated service.
Testing can include:
- Drug Excipient compatibility studies
- Solubility and solution stability studies, particularly for poorly soluble compounds
- Homogeneity testing
- Assay and related substances
- Dissolution/drug release evaluation of immediate or modified release formulations
- Prototype evaluation with accelerated/stress stability studies
Method Development
We have extensive experience in developing test methods for the pharmaceutical industry (including comparator products) and can provide a structured, focused, step-wise approach to the process. We can develop new test methods or improve existing methods. We can tailor existing test methods to your drug substance or drug product and are experienced in test method development for small molecules and large molecules (polymers and biopharmaceuticals).
In addition, we have a long-standing and in-depth experience in developing “stability-indicating” analytical methodologies for active and related substances, by performing forced degradation studies and assessing and developing the stability indicating power of the methods on the degraded samples. This step allows that, if needed, the developed methodologies can be used for both release and stability testing of API and drug products.
We can compose a development history report to describe what was successful and what was not in the method development process. We will also generate a test method for the development of a new method and, if an existing test method was improved, we will write a new version of the test method.
Method Validation
Regulatory agencies expect to see some level of validation for non-compendial methods. Whether your submission is an IND, NDA, IMPD, MAA, CTA, aNDA, or BLA, we can provide the appropriate level of validation for test methods in your CMC section. All relevant guidelines, such as the ICH guidelines, will be followed.
We typically validate test methods for API, drug products, and drug product containers. The usual validation process involves a validation protocol that is signed by both the client and Aptuit. We complete the laboratory work in agreement with the protocol and the test method that is being validated.
We can summarize validation results in the final version of the test method and/or describe the results in detail in a stand-alone validation report. Some typical test method validation parameters are ruggedness, linearity and range, limit of detection, and limit of quantitation, accuracy, precision, specificity, robustness, and solution stability.
Method Transfer
At Aptuit, we can transfer your existing method to our facility and vice versa. Transfer protocols (with acceptance criteria) can be written by the client, Aptuit, or a combination of both parties. We will execute the transfer protocol and issue a transfer report. Method transfers can be simple or complex depending on the stage of drug development, including test methods that are run simply for informational purposes only or well established and validated methods for marketed human and animal drug products.
Our method transfer process will demonstrate that the method can be run to our client’s satisfaction. A method transfer allows both parties to run the method without the duplication of any validation activities that have already been performed.