ADME AND EARLY DRUG DISCOVERY (EDD) ANALYTICAL SERVICES
Apeloa early discovery services include a focus on ADME and EDD analytical services, fully supported by comprehensive analytical capabilities. ADME stands for Absorption, Distribution, Metabolism and Excretion. This is of particular importance in drug discovery as it helps to define the activity of a drug in the body with regard to drug metabolism and pharmacokinetics. The ADME study data can help direct scientists towards viable candidates and specific targets for future R&D. Having strong analytical capabilities that can rapidly analyze candidate molecules can help to accelerate their early development programs. Apeloa’s comprehensive ADME capabilities are leveraged in combination with its extensive analytical testing capacity to quickly determine ideal targets for further development with confidence.
APELOA EDD ANALYTICAL SUPPORT FOR ADME STUDIES
Over the last 30 years, Apeloa has growth its analytical capabilities to match its ever-expanding business development and services. With comprehensive analytical support at each of its sites, staffed and equipped to efficiently complete the necessary testing and method development, Apeloa is well positioned to maintain both quality and timelines for customers. Our analytical laboratories meet the regulatory and quality requirements of major regulatory bodies and follow strict test methods and quality management principles to deliver customer product on time. Whether its GMP manufacturing support for established product manufacturing or the development of new and innovative methods for early-stage projects, Apeloa CDMO has the right capabilities.
APELOA CDMO ANALYTICAL SUPPORT FOR ADME STUDIES
Comprehensive analytical services performed by highly experienced scientists are critical for the early development of any new candidate molecule. Being able to predict the most optimized and viable target for the intended mechanism of action can make all the difference in the success of the product. When performing such important work, being able to develop accurate and reliable study data through robust analytical testing can direct scientists to the most appropriate options for further development and investment. Some of the specialized capabilities offered for ADME studies include:
- Structure characterization & verification
- Chiral Separation including SFC separation
- Analytical method development for impurities (genotoxic & elemental)
Apeloa operates an analytical laboratory dedicated to Early Drug Discovery (EDD) stage services. The EDD lab is equipped with modern instrumentation specifically dedicated to supporting EDD and ADME requirements, including Supercritical fluid chromatography (SFC) for chiral separations.
The Apeloa Analytical Test Center (AATC) is the company’s central testing lab housing the most advanced and sensitive analytical equipment operated by our most experienced scientists. They bring decades of experience in discovery and early phase development services for a range of molecule types. Their objective is to characterize molecule candidates so that they can be selected for further development based on hard analytical data. They also have the ability to test and support ADME studies with rapid turnaround times and meaningful data analysis to support customer decisions.
ADME SERVICES
Apeloa CRO services bring a great deal of scientific expertise to ADME studies. ADME stands for Absorption, Distribution, Metabolism and Excretion and their study is used to help determine how a living organism will process a molecule or drug. ADME represents the four steps of pharmacokinetics, with each providing a piece of the puzzle regarding molecule viability.
- Absorption – the study of how the molecule moves from the administration site into the bloodstream. There are numerous routes of administration and processes by which the compound crosses a membrane and enters the bloodstream. Absorption is primarily the determination of bioavailability.
- Distribution – Once the molecule has been absorbed, it typically moves around the body via the bloodstream (or cell to cell). Factors like blood flow, lipophilicity, tissue binding and molecular size can all impact the distribution efficiency.
- Metabolism – The drug is then transformed by organs or tissues or is metabolized. Adverse outcome pathways (APOs) map out the unique metabolic pathway of the drug and help to determine potential safety or toxicity profiles of the drug as well as predicting drug-drug-interactions.
- Excretion – Scientists study how fast the metabolized drug can be eliminated from the body and what pathways are used to exit the body. Drugs that bioaccumulate in the body can lead to adverse effects on the person.
Apeloa CDMO provides complete CRO services, that include ADME studies supported by in house analytical services capabilities. ADME services include:
- LogD / Solubility (HT/SSF) – measures drug distribution under different pH values
- Permeability (PAMPA): Parallel Artificial Membrane Permeability Assay – used as an in-vitro model of passive transcellular permeation over a large pH range.
- Stability (chemical, liver-microsome, plasma) :
- chemical stability
- liver-microsome stability
- plasma stability
- CYP-TDI/PPB – CYP enzyme analysis with time dependent interval and Plasma Protein Binding analysis for metabolism measures.
- CYP-TDI CytoChrome p450 analysis of time dependent inhibition measures change in potency after an in-vitro incubation
- Plasma Protein Binding (PPB) gives insight to the drug interactions with plasma proteins, impacting dosing considerations