Method Development
Analytical tests are developed to support the entire drug development process, and tests are required for all phases of the drug development process: lead candidate selection, manufacturing of a new drug, quality control, quality assurance and more.
These all-important tests must be qualified and then verified and be validated for testing; they must be in accordance with international standards for conducting tests for medical products. All tests need to be cost-effective to optimize the development of your new drug or API. The best way to achieve this is to outsource to a reliable cGMP laboratory.
Take advantage of the right methods for your product at each stage of the development cycle to develop a safe, reliable and efficient pharmaceutical product.
method development services
Pharmaceutical manufacturers need to be assured that the drugs they are producing are safe and effective. They also have to make sure the drugs are produced as intended. Analyzing products from the earliest stages, from extraction to formulation to packaging, requires a large amount of investigation.
Valentia conducts testing for possible contamination, possible degradation, defects in the manufacturing process, product stability, and the efficacy of the drugs. We have the team, the facility and the capabilities to offer top of the line analytical services to pharmaceutical manufacturers.
Our method development services
Valentia Analytical helps pharmaceutical companies develop and validate methods to test various drug characteristics. Our cGMP laboratory is an industry leader in the development of methods for identification tests, impurity tests and assays.
Identification Tests
To establish that an analyte is of interest in the drug, it is necessary for the authorities to test that the drug substance analyzed does contain the alleged drug in question. When the identification test is done, the drug can claim to possess the function offered by the drug compound.
Impurity Tests
The purity profile determines whether all residual impurities present in the sample are within limits. In the purity tests, accurate definition of the sample’s purity is important to be able to show that all impurities are safely controlled in the drug. The method could be either a quantitative or a limit test for the determination of impurities in the sample.
Assays Tests
Assays are often performed to be sure the per-unit amount of active pharmaceutical ingredient is the same as stated on the label. They can assess the content of the analyte or the potency of it. This is most importantly done to check the amount of active pharmaceutical ingredient (API) inside the drug product.
How can an analytical laboratory benefit pharmaceutical companies?
In order to develop reliable methods, you need a good understanding of current regulatory expectations of method development, and you also need advanced instrumentation and the associated necessary skill set that will allow you to run a robust method. Furthermore, a regulatory approach to method development can ensure that the method you finally choose for release meets all required, appropriate and relevant regulations and requirements.
Valentia Analytical can oversee the development of good analytical methods for your pharmaceutical compounds. We work in partnership with your team to ensure an efficient drug development process and accelerate the commercialization of your new drugs on the market.
Samples typically come with multiple components. The first step is to be able to distinguish the analyte of interest from others. This is done exploiting chemical properties of analytes to achieve physical resolution, utilizing selective detection, or applying a combination of both.
- Physico-Chemical Testing such as Appearance, pH and Osmolality;
- Ultra-Violet Spectrophotometric Analysis for Content;
- Reversed-Phase Chromatography for identity, content, purity, and impurity;
- Ion Exchange Chromatography for charged variant analysis of proteins;
- Size-Exclusion Chromatography for aggregate and impurity;
- Bioassay for Potency;
- ELISA for Binding and Impurities;
Valentia produces methods that respect international standards of method validation and development. We follow established guidelines and procedures recommended by entities such as the International Council for Harmonisation (ICH), US Food and Drug Administration (FDA), and the European Medicines Agency (EMA) to ensure there are no costly delays in your development.
Valentia goes beyond standard operating procedures by following recommendations from:
- International Council for Harmonization guidelines (ICH);
- Good Manufacturing Practices (GMP);
- Good Laboratory Practices (GLP):
Why work with Valentia Analytical?
Valentia has been leveraging years of experience across industries to develop robust analytical methods for techniques including UHPLC, HPLC, CE-SDS, CIEF, and GC, and conducts method validation according to regulatory guidelines including ICH Q2. Our analytical professionals use cutting-edge equipment and techniques to generate methods trusted by industries around the world.
As a leader in analytical services, Valentia Analytical has a wide range of core capabilities, a high level of skilled staff that understands how to address your individual needs and an approach based on delivering the data you need to make informed decisions.
Learn more about method development and Valentia’s services
Analytical method development can be described as the process of designing, developing and validating a test designed to measure a specific drug’s characteristics. A well designed and validated analytical method is the important step in the development process according to Good Laboratory Practice (GLP).
The aim of method development is to design tests that will measure the drug substance or API (Active Pharmaceutical Ingredient). Tests for identity, purity, permeability, stability and potency of drugs, bioavailability and stability are a part of this overall aim.
The analytical process that will be necessary to help develop cost-effective, accurate, precise and reproducible quality standards is a crucial part of the product development process. They are particularly important during the manufacturing process of a new drug, where strict standards and requirements by regulatory bodies such as the FDA (Food & Drug Agency) must be met to be sold on the market.
Effective method development aims toward the optimization of lab resources using a series of methods that meet the exacting standards required at certain drug development stages. Such standards may be as stringent as regulatory approval from pharmaceutical regulators, while at other drug development stages, such standards may be simply adequate.
However, effective methodology must continue to improve over time in order to achieve these standards. Consequently, method validation and method transfer may require constant improvement as new analytical approaches are introduced, new applications are explored, and new instrumentation and software upgrades become available.
This is why pharmaceutical businesses started relying on specialized laboratories such as Valentia Analytical for their analytical method development
Analytical methods in drug development need to be distinguished between qualitative and quantitative methods.
In compound testing, there are several validation parameters, including specificity, limit of detection, limit of quantitation, linearity, accuracy, range, precision (under laboratory repeatability condition), and stability.
New requirements and parameters may be implemented if the active pharmaceutical ingredient (API) changes its composition or the drug product structure changes. New regulations will also be applied if changes are made to analytical procedures.
An example of ‘transfer’ is to analyze in detail if a laboratory can perform an analytical procedure developed in another lab. They are generally used upon request by one site when it wants to verify a different site’s ability to perform the method. Analytical methods are commonly transferred from the originating (transferring) site to other laboratories during the clinical, scale-up, or commercialization phases of product development.
Good Manufacturing Practice (GMP) is a monitoring and regulating framework for the production of clinical-grade drugs. The guidelines cover the entire manufacturing process, from how a drug is formulated to the processes of its distribution. They help firms demonstrate that clinical-grade medicines are safe, effective and deliver on brand promises. GMP allows drugs to be tested on patients just as in the real world, and it ensures that the drugs have been produced in accordance with the highest standards in industry.
The difference between GMP and cGMP, although they are similar, is that cGMP uses new, innovative technology, which may be more expensive than regular GMP. The cGMP products undergo far more testing along with newer, more in-depth testing. cGMP also goes beyond regular GMP by focusing more than just on the quality of the new drug.