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Preclinical Development Services

 

preclinical

Description:

We offer preclinical evaluation and drug development services for biotech and pharmaceutical companies to accelerate their new drug development processes. This service covers following fields: Bio-analysis, Molecular and Cell Biology, Pharmacology, and Toxicology.

We specialized in antibody, small molecule, siRNA, protein, and gene therapy leads. General process includes:

  • Design and selection of targets via high-throughput (HTP) screening
  • Target validation
  • In vitro studies based on different assays
  • Formulation development
  • In vivo evaluation of targets in mouse/rat models (PD, PK, efficacy, ADMET, etc.)
  • Consultation for regulatory filing

Advantages:

  • Extensive research and development experience
  • Well-equipped facility
  • Professional project management
  • Cost-effective and results-oriented

Deliverables:

All deliverables are well-defined in individual project protocol on case-basis.

Case study:

Development for siRNA target:

1. Design and selection of siRNA via HTP screening
2. Determination of EC50 of selected siRNA in cultured cells
3. Functional study of RNAi ( i.e., qRT-PCR, ELISA/Western blot, and 5’-RACE assays)
4. In vitro testing of siRNA product (cell-uptake efficiency, cell apoptosis and proliferation assay, and cytotoxicity assays)
5. Formulation development for in vivo application
6. In vivo evaluation of siRNA product in mouse/rat models (target gene KD, biodistribution and kinetics , efficacy, and toxicity)

Requirement:

We treat each project as unique and all materials/information provided for project finalization and implementation as confidential under NDA. Our technical representative will work with clients directly to clarify details and develop a technical proposal with cost and time line estimate.

 

For more technical details and a quote, please contact us.

Cat. #
Project Name
Price
6001 Bio-analysis Service
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6002 Drug Development Service (in vitro)
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6003 Drug Development Service (in vivo) This e-mail address is being protected from spambots. You need JavaScript enabled to view it.
6004 Assay Development  Service (in vitro) This e-mail address is being protected from spambots. You need JavaScript enabled to view it.

 

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