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Drug Discovery Support Services and Solutions

Analytical Chemistry

RDN’s streamlined analytical chemistry platform offers the opportunity to obtain the ADME profile and physicochemical property of compounds even at the very early stage of lead finding and optimization, which provides valuable information for selecting promising compounds for the next stages. RDN also offers modern formulation technologies adapted for the practice of early stage research, for which combination with our expertise of bioanalysis enables clients to obtain the preliminary evidence of in vivo efficacy using prototype compounds, of which physicochemical properties are not fully optimized.

Early ADME Profiling

Our early ADME profiling service, based on proprietary automated high throughput assay technologies and accumulated data, aids in the section of promising compounds for the next stages. At the late stage of the discovery research, the D/P system,* the in vitro simulator of gastrointestinal absorption, enables predictions of the pharmacokinetics profiles of different formulations and helps clients select candidate compounds for development. * D/P system was originally developed by Prof. Yamashita at Setsunan University and licensed to RDN. RDN is continuously optimizing the system in terms of throughput and predictability.

Physicochemical Property Analysis and Preliminary Formulation

For the effective selection of candidate compounds for development, we offer high throughput physicochemical property analysis services. The risk assessments of compounds executed at the early stage of research guide the strategy of compound optimization and minimize project failures. We provide solutions to solubilize hardly-soluble compounds using various formulations and/or DDS, so that in-vivo pharmacokinetics can be evaluated using prototype compounds. The consulting services on the issues caused by the physicochemical properties will also be available.

Bioanalysis

Through the expertise of various isolation technologies and mass spectrometry, we offer in vivo quantitative analysis of drug candidate compounds (small molecules /biologics) for pharmacokinetics and their related small molecules as pharmacodynamics biomarkers, where we not only apply the analytical methods given by clients, but also develop novel methods for specific target molecules, if necessary.

Chemistry

Utilizing broad organic synthesis technologies and facilities, including high-throughput, low-volume parallel synthesis and medium- and high-volume synthesis, RDN provides various compounds required for different stages of drug discovery research as described below. Our experienced chemists offer optimized synthesis methods in terms of cost, time and scalability.

Synthetic Chemistry Expertise

We provide a wide variety of bioactive substances and intermediates for exploratory research in small, medium and large quantities in response to client requests. The products are delivered with the standard instrumental analytical data supporting their structures and quality.

Compound Library Construction and HTS Hits Profiling

The construction of DS’s original Pharma Space Library (PSL) is ongoing, utilizing technologies and accumulated know how. The technology of parallel synthesis, which has been developed through compound library design and synthesis, is effectively applied to HTS hit expansion for effective creation of lead compounds.

Design/Synthesis of Tool Compounds for Chemical Biology

Collaborating closely with related functions, the expertise of synthetic chemistry is applied to provide tool compounds that are used to identify target macromolecules for the compounds acquired from phenotype screenings.

Hit to Lead

RDN offers a comprehensive platform for validated hits acquisition, consisting of library management, HTS campaign and, hit validation, which are supplemented with the support of protein production and structure biology functions.

Compound Library Management

For the execution of the high-throughput screening (HTS) campaign, compound libraries, including DS’s proprietary PSL (Pharma Space Library) are maintained in the automated storage and ready to dispatch on request. The cherry picking process based on the computerized retrieval system allows for the flexible handing of library compounds.

Hit Identification

RDN is successful in operating HTS campaigns using high density plates with 1536 and 3456 wells, which reduces both the time and cost for acquiring hits. To improve the success rate of the HTS campaigns further, our efforts are now focusing on the optimization of assay methods in terms of sensitivity, specificity, speed and cost.

Hit Validation

Hit compounds acquired in a HTS campaign must be confirmed by another method not used for the HTS campaign, including detection of direct interaction by physical methods. It is very critical, we believe, for hit validation to design hit validation strategy combining assay methods with different readouts and different detection principles.

Structure Based Hits Evaluation and Structure Guided Lead Optimization

To detect the direct interaction of hits or other bioactive molecules with the intended drug targets, X-ray, NMR and SPR are applied depending on the extent to which the details of structural information is required. The modes of interaction between bioactive compounds (drug candidates) and drug targets derived from experimental X-ray analysis or in silico molecular modeling are interpreted by our experts and shared with clients to efficiently create and optimize lead compounds from hit compounds.

In vivo Pharmacological Evaluation

RDN offers in vivo pharmacological screening in various therapeutic areas for in-depth evaluation to guide lead optimization and select clinical candidates.

Pharmacological Testing in Various Therapeutic Areas

We provide high-quality in vivo pharmacological screening in cancer, cardiovascular and metabolic disease areas, among others, for optimization of lead compounds.

Construction of a novel in-vivo assay system and custom pharmacological testing

Our value-added solution services include the construction of a new pharmacological assessment system with improved pathological similarity to human disease, and custom pharmacological testing with the composite protocol, in which the in-vivo pharmacological assay is combined with any other test items like in vitro bioassays, pharmacokinetics, pathological assessment, and others.

Recombinant Protein Supply

RDN is constructing a streamlined recombinant protein production platform using the expression systems of bacteria, insect cells and eukaryotic cells, where each process element is parallelized to absorb the negative impacts on timeline and cost, which may be inevitable due to the heterogeneous nature of proteins.

Production and purification of proteins for HTS, in vitro biological assays and structure biological analysis

Besides offering a protein production service to clients, our protein production platform contributes to improved productivity of other functions by managing the internal supply of proteins required for different purposes.

Omics Analysis

With a multifaceted approach that utilizes various cutting-edge bioanalytical technologies pivoting on “omics” technologies, we provide effective solutions for issues that range from the search for biomarkers, an essential part of drug discovery activity today, to the identification of compound targets.

Biomarker Searches, Action Mechanism Analysis, New Drug Target Searches

We are constructing a research platform that allows us to adopt a multifaceted approach utilizing genomics, proteomics, chemical biology and other “omics” technologies, supplemented with other advanced research technologies, including high-sensitivity measurement methods and bioinformatics for analyzing large quantities of omics data and clinical and non-clinical data. Utilizing this platform, we conduct biomarker searches and identification, which can be used for efficacy assessment and sensitivity prediction. Within the scope of our platform are new drug discovery target searches and analysis of target molecule action mechanisms. The results are shared with clients and utilized for innovative pharmaceutical development through our solutions and consulting services.

Biological Analysis

RDN builds assay methods that combine various measurement methods with pathological analysis technologies to rapidly provide highly precise data related to compound assessment and biomarker measurement, which are essential to drug discovery research.

Biochemical and Pathological Analysis

Using specimens derived from animal disease models, human cell strains, and clinical samples, among others, we conduct high-precision multiplex assays for blood and biochemical markers necessary for biomarker research and efficacy assessment. Our services for advancing drug discovery projects include cell-based assay construction and execution, histopathological analysis (including immunohistochemistry, light microscopy and electron microscopy sample production), quantitative analysis of genetic expression, and cancer cell growth testing.

Natural Product Chemistry

Utilizing our world-class collection of microbial resources, RDN offers unique opportunities to identify bioactive compounds difficult to find from chemical libraries, and to design the novel synthetic route using microbial conversion.

Microbial Resources, Extract Libraries and Bioactive Substance Searches

We supply high-quality, highly diverse extract libraries taken from a range of microbial resources collected using proprietary separation sources, processing methods and separation technologies. Based on various screenings using this highly unique extract library, we carefully scrutinize the potential of active constituents and isolate bioactive compounds with required profiles using our expertise in purification and structural analysis.

Microbial Conversion

Utilizing isolated genes responsible for a biosynthesis or conventional microbial conversion, we provide alternate routes for creating intractable compounds by chemical synthesis, which helps accelerate drug discovery processes.