By Pipeline Biotech…
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Pipeline Biotech is an in vivo CRO providing research pharmacology services for biotech and pharmaceutical companies, including dedicated and active partner services in drug discovery and pre-clinical development.
When in vitro systems indicate that a drug substance has potential as a viable cancer chemotherapeutic or biologic entity, the next step is to test its abilities and potency in a living organism.
Pipeline biotech offers a balanced set of in vivo mouse tests to provide the customer with a solid base for selecting or de-selecting the target drug candidate for further development.
In-mouse testing is useful in any of the following applications:
- Research Pharmacology (DMPK)
- Formulation of dose solution
- Pharmacokinetics (PK)
- Biodistribution (BioD)
- Efficacy testing (Xenograft)
- Selection of test system
- Efficacy – inhibition of tumor growth (Xenograft)
In-mouse efficacy testing – the corner stone
In-mouse efficacy testing is the cornerstone of effective research, since choice of research model plays such a crucial role in returning strong selection or de-selection answers.
Pipeline Biotech can partner the client through this key part of the process, helping to choose the most appropriate xenograft model and offering different levels of support.
Test of treatment efficacy is carried out by xenograft, i.e. immunodeficient mice transplanted with human cancer cells or patient derived tissue, inoculated s.c.orthotopic or i.v. for disseminated models.
Read-outs provide tumor growth inhibition and clinical symptoms data.
Predictability – what to expect for the clinical phase
Together with Medical Prognosis Institute (MPI), Pipeline Biotech offers an advanced model selection tool to European sponsors. The MPI’s proprietary drug response predictor allows predictions of treatment responses and selection of responding patients, as well as selection of the most suitable xenograft tumor models. The technology is based on algorithms applied to array data of 10-60 cell lines treated with the target drug. Combined with xenograft efficacy data, this forms a powerful tool for prediction of the treatment response in patients.
Measuring track to tumor in vivo
For small chemical entities particular the pharmacokinetic profile is important for planning a dosing schedule securing adequate concentration at the site of the tumors. For the antibody based drugs, biodistribution and specific targeting to the tumor is important for the efficacy of the treatment. Pipeline Biotech offers a flexible service to determine these parameters and then to enhance the quality of the efficacy testing.
Quality and animal ethics
Pipeline Biotech has been certified GLP Compliant since 2003 and GMP Compliant since 2006, as audited by the Danish Medicines Agency.
All experiments are conducted in accordance with EU regulations and approved by the National Animal Experiments Inspectorate. Test animals can be housed at different levels of barrier protection including GMO Class I and Class II and Biohazard Class III.