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Our Drug Candidates
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Our Drug Candidates
About the new drug candidates
of Advalife Science
Contents
Overview
What our new drug candidates are
At Advalife Science we understand life as a complex system in which molecules, cells, tissues, immunity and metabolism interact with one another, and we research and develop new drug candidates that are not confined to a single-component, single-target framework.
The principal new drug candidates we develop have a complex composition made up of multiple biologically derived components. They are characterised by scientific evaluation that covers not only the individual components but also their interactions with multiple targets and pathways in the body.
While we work to elucidate composition and properties, quality, biological activity and mechanism of action, we carry the work step by step through manufacturing and CMC, non-clinical study and clinical development, and examine their potential as pharmaceutical products.
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Starting Point
What they are made from
The manufacturing process for these drug candidates uses human-derived stem cells as one of its raw materials.
They are not, however, cell preparations intended for the administration of stem cells themselves, and the final drug candidate contains no stem cells.
Nor do they use genetically modified stem cells, and they are not preparations produced by recombinant DNA technology. No animal-derived raw materials are used in the manufacturing process.
Taking human-derived stem cells as one starting point in the manufacturing process, we research and develop, as a new drug candidate, the complex composition of multiple biologically derived components obtained from them.
Distinction
Not cell culture supernatant, and not an exosome product
These drug candidates are not cell culture supernatant used as a drug candidate in its own right.
Nor are they being developed as preparations composed principally of exosomes or extracellular vesicles alone.
Taking human-derived stem cells as one starting point in the manufacturing process, we evaluate the composition and properties, quality and biological activity of the composition as a whole, and carry out the scientific verification required of a pharmaceutical product in manufacturing and quality control, pharmacology and safety.
For that reason, rather than treating any single component as the substance of the drug candidate, analysing the interactions between multiple constituent components and multiple biological pathways is a central principle of our research and development.
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Composition
What they contain
These drug candidates are not composed of a single chemical substance. They have a complex composition containing multiple biologically derived components.
We are currently researching the analysis and characterisation of each constituent component and its relationship to biological activity.
Detailed identification and quantification data for individual components, and detailed compositional analysis data such as mass spectrometry, are not published at this stage.
Not publishing detailed compositional information does not mean that the components and the quality have not been analysed or evaluated. We manage information appropriately according to the stage of development, while carrying out the scientific evaluation and the characterisation of quality attributes that pharmaceutical development requires.
Manufacturing & Safety
Manufacturing, quality and safety
With a view to development as pharmaceutical products, we are evaluating raw materials, the manufacturing process, quality attributes, specifications and stability from a manufacturing and CMC perspective.
We also carry out non-clinical evaluation of pharmacological action and of safety. Non-clinical safety studies are conducted in compliance with GLP.
Building on this scientific verification, we advance manufacturing and quality, non-clinical study and clinical development as a single, continuous pharmaceutical development process.
Information Disclosure
Why we do not publish the full raw materials, composition and manufacturing method
These drug candidates are currently at the research and pharmaceutical development stage.
Detailed information on raw materials, the manufacturing process, composition, analytical data and quality specifications includes patents, manufacturing know-how, trade secrets and CMC information relevant to future marketing authorisation applications. For the protection of intellectual property and the appropriate management of information, it is not published at this stage.
The technical information set out in published patents and the detailed CMC information used in actual pharmaceutical development are not necessarily the same. We disclose scientific information that can appropriately be made public, while continuing our research and development.
※ The new drug candidates described on this page are at the development stage. This page does not indicate the efficacy, effects or safety of an approved pharmaceutical product. This information is not intended to recommend any particular treatment.
Enquiries about our new drug candidates
We welcome enquiries about our research and development, research collaboration and licensing.