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Animal Experimentation & Non-Clinical Trial

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Service Description

Hokkaido System Science Co., Ltd. (HSS) has entered into a business collaboration agreement with Transgenic Inc. (TG) to provide customized animal study services for the research and development of oligonucleotide therapeutics.

We propose appropriate in vitro, in vivo, and nonclinical studies tailored to each development stage and objective, including pharmacokinetic evaluation of nucleic acid therapeutics. Our services cover the development process from early drug discovery research through nonclinical development in preparation for IND and NDA submissions. We also support studies designed to generate supporting data for exploratory clinical studies, including investigator-initiated trials.

NEW

Pharmacokinetic Evaluation of Nucleic Acid Therapeutics

We accurately evaluate the pharmacokinetics (PK), blood concentrations, and tissue distribution of nucleic acid therapeutics, providing optimal data for each stage of development.
We offer two service options to meet your specific needs.

1
Full-Service Support, from Dosing to Data Analysis
Our integrated workflow covers the entire study process from dosing and sample collection to bioanalysis and data interpretation.
full service
2
Analysis of Submitted Samples
We receive samples for analysis and perform measurements using LC-MS/MS or HPLC.
submitted sample

Evaluation Parameters

By measuring blood concentrations and analyzing tissue distribution, we visualize the pharmacokinetics of nucleic acid therapeutics and provide strong support for their development.

Before placing your order
  • The analytical method may need to be optimized depending on the type and modifications of the nucleic acid.
  • The time required for analytical method development may vary depending on the study design.
  • Please provide information about the test article, including its sequence, modifications, and storage conditions.
  • Please provide the required amount of the test article.
  • Quantitative analysis may require a suitable reference oligonucleotide with a comparable length and similar chemical properties to the test article.

Studies by Development Stage

Representative studies available through our services are presented below by development stage.

1. Drug Discovery Stage

List of Test Items
List of Quality Tests
No  Test Name Example
1
 In Vitro Pharmacology and Toxicity Studies (Conducted by ACEL) ー
2
 In Vivo Mini-Toxicity Study Short-term repeated-dose study using wild-type or genetically modified mice
3
 Other In Vitro Studies Studies using human blood to evaluate oligonucleotide-specific adverse effects

 

2. Non-Clinical Development – Stage 1 (Preliminary GLP Phase)

List of Test Items
List of Quality Tests
No Test Name Example
1
 Dose Range-Finding (DRF) Study in Rodents 2-week intermittent dosing study using genetically modified mice
2
 Dose Range-Finding (DRF) Study in Non-Rodents 2-week intermittent dosing study in dogs

 

3. Non-Clinical Development – Stage 2 (IND-Enabling GLP Studies)

List of Test Items
List of Quality Tests
No Test Name Example
1
 Repeated-Dose Toxicity Study in Rodents 4-week intermittent dosing study using genetically modified mice
2
 Repeated-Dose Toxicity Study in Non-Rodents 4-week intermittent dosing study in dogs

 

4. Non-Clinical GLP Studies Supporting Phase 2 Proof of Concept (POC)

List of Test Items
List of Quality Tests
No Test Name Example
1
 Repeated-Dose Toxicity Study in Rodents 3-month intermittent dosing study using genetically modified mice
2
 Repeated-Dose Toxicity Study in Non-Rodents 3-month intermittent dosing study in dogs
3
 Teratogenicity Study in Rodents and Rabbits –
4
 ADME Study in Rodents Absorption, distribution, metabolism, and excretion study

 

5. Non-Clinical GLP Studies Supporting NDA Submission

List of Test Items
List of Quality Tests
No Test Name Example
1
 Chronic Repeated-Dose Toxicity Study in Rodents 6-month intermittent dosing study using genetically modified mice
2
 Chronic Repeated-Dose Toxicity Study in Non-Rodents 9-month intermittent dosing study in dogs
3
 Developmental and Reproductive Toxicity (DART) Study in Rodents Fertility and early embryonic development study; peri- and postnatal development study
4
 Carcinogenicity Study 6-month carcinogenicity study using genetically modified (rasH2) mice

 

6. Non-Clinical Studies Supporting Exploratory Clinical Trials (Including Investigator-Initiated Trials)

In addition to studies listed in sections 1–5, we propose non-clinical studies designed to support exploratory clinical trials.

List of Quality Tests
Example
Extended Single-Dose Study Using Genetically Modified Mice
7-Day Repeated-Dose Study Using Genetically Modified Mice

 

Studies Using Genetically Modified Mice

For mouse studies listed in sections 2–6, we recommend the use of genetically modified mice to enable clearer evaluation of on-target toxicity. In addition, Transgenic Inc. (TG) is capable of generating and expanding a wide range of transgenic mouse models.

Click here for details (TG website)

How to Request Our Services

STEP 1

Consultation
Please feel free to contact us via the inquiry form regarding our services.
e.g. in vitro studies / in vivo studies / non-clinical studies / generation of genetically modified mice, etc.

※ Free-of-charge web consultation is available on request.

STEP 2

Quotation
We will propose an appropriate test plan and quotation based on your inquiry.

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