Pipeline Biotech Preclinical CRO Services
Pipeline Biotech is a CRO, specialised in preclinical research services. We have a flexible approach to specific client needs that is anchored in our basic, standardised systems and disease models. More than 130 sponsors have repeatedly used our services during the last ten years. We work for major European pharma and biotech companies.
In vivo research pharmacology
We perform in vivo research pharmacology, including efficacy studies in various disease models and pharmacokinetic and early toxicology screens for drug characterisation purposes. We focus on the major disease indications:
- Obesity and diabetes
Tumour biology services – xenografts
Pipeline Biotech offers a comprehensive system of experimental xenograft models and setups for the testing of anticancer effects of new drug candidates. Chemical compounds as well as gene vectors, monoclonal anti-bodies and other biological products may be tested.
Inflammatory disease models
Pipeline Biotech offers a range of inflammatory disease models in mice and rats. The models include:
- Chronic obstructive pulmonary disease
- Ulcerative colitis
- Rheumatoid arthritis
- Multiple sclerosis
- Pro-inflammatory models
Pharmacokinetic, PK and DMPK services
Pipeline Biotech offers the following pharmacokinetic, PK and DMPK services:
- Mice, rats, rabbits, guinea pigs, mini-pigs
- Screening of NCEs and chemicals
- Isotopes: C-14, H-3, P-32, S-35, I-125
- Long-term regular schedule or ad hoc projects
- Advising in dosing methods and sampling methods
- Bioavailability, metabolism and biodistribution
Discovery toxicology services
In the selection of drug candidates for further assessment and development, discovery toxicology (i.e. pre-regulatory toxicology) is usually necessary. When there is a large pool of NCEs to choose from simple, fast and cost-efficient investigations of the compound’s toxicological effects in vivo are needed.
GMP batch release
We are certified to perform batch release testing according to GMP guidelines and EP / BP / USP pharmacopoeias. We work with QC production units of the pharmaceutical industry. We have established protocols for technology transfer and sourcing of new bioassays.
Laboratory animal facilities
Our laboratories are designed and approved to experimental animal research and cell biology. Mouse, rat, guinea pig, rabbit and mini-pig species of laboratory animals can be housed at different levels of barrier protection including GMO Class I and Class II and Biohazard Class III. Our laboratories have been GLP compliant since 2003 and GMP compliant since 2006.
Ethical preclinical research services
All studies are performed in strict accordance with EU regulations and are approved by the National Animal Experiments Inspectorate under the Ministry of Justice. Educated personnel under veterinary supervision handle the animals.
Products and Services
Rational drug discovery requires an early appraisal of all factors impacting on the likely drug-ability of a new chemical entity (NCE) in the subsequent preclinical, clinical and commercial phases of drug development. Since 39% of all NCEs fail on poor PK properties, pharmacokinetics haRead more