Scientists and researchers can purchase biotechnology reagents and kits from life science product suppliers as well as obtain contract research services from preclinical and clinical CROs (contract research organizations). Biology CRO and preclinical contract research services add a tremendous value to sponsors needing help with pharma or biotech product development, regulatory submissions, and patent applications by providing their research laboratories, scientists expertise, and therefore reducing the potential for product or process failure. Sponsors should select a CRO that is compatible with their needs and project requirements. As companies have more pipelines and are under FDA scrutiny, it makes sense to outsource certain research efforts to biology CRO to handle experimental work, product development, and associated data gathering, analysis, and reporting.
Main FDA requirements for IND applications are safety and efficacy studies that always involve toxicology studies. The design and conduct of general toxicology as well as in some cases the teratology, reproduction and neurotoxicity studies is carried out by specialized contract research companies, e.g. Altogen Labs CRO that offers largest set of validated xenograft models (list). Often in preclinical toxicology studies multiple animal models are used to study acute, subchronic, chronic, carcinogentic, teratogenic effects, as well as pharmacokinetics and pharmacodynamics (PK/PD) through various routes of administration.
A variety of biomedical products and services are commercially available to support pharmaceutical research and development. Recent scientific discoveries, such as RNA interference (RNAi) allow pharmaceutical scientists and researchers to perform gene knockdown experiments to silence almost any gene in an organism’s genome. New capabilities are enabled by many types of new medical and research instruments which in combination with new laboratory research methods allow us to understand the function of virtually every gene in an organism’s genome, which in turn have very important applications in clinical research and medicine.
List of companies providing Biotechnology Research Services:
Safety-IND in vivo CRO services, phatm/tox studies (Altogen Labs)
Microarray design, printing, processing (Amersham / GE Healthcare)
mRNA and protein microarray and ELISA services (Arrayit Corp)
microRNA expression array services, oncology diagnostics (Asuragen)
DNA and RNA oligonucleotides, qPCR probes, oligo synthesis and purification (Integrated DNA Technologies)
Contract research organization Wikipedia (CRO)
Transfection resource, protocols, services (Cell Transfection Wiki)
Viral constructs engineering and virus particle generation service (Vector Biolabs)
Stable cell line generation and RNAi Services (Altogen Services)
NGS sequencing, drug characterization and pharmaceutical services (Exiqon)
ELISA assay development and tissue culture CRO services (ELISA Development)
siRNA transfection services CRO (siRNA Transfection)
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