Contract research organizations, or CROs fulfill a need for sponsors, which are usually large biotechnology and pharmaceutical companies needing to outsource work. CROs provide various preclinical research and development services from study design through IND regulatory submissions. Preclinical studies require specific research area knowledge and experimental expertise, as well as laboratory quality control system where preclinical experiments are conducted. Quality control system (GLP) requires enormous amount of experimental and QC data gathering and analysis, and if a company is having difficulty managing a study due to lack of resources or manpower – then an effective solution is to outsource to a contract research laboratory (such as Altogen Labs CRO).
Biology CROs work closely with their clients, advising them on preclinical experimental design, compound testing strategies, protocols, data management and report preparation. Whether it is drug discovery, drug development, or protein manufacturing, partnering with a CRO can result in significant cost-savings and a more streamlined process towards bring a product to market. Particularly in the early stages in the drug or medical device development process, a large amount of analytical data must be acquired to validate the usefulness of the product. Preclinical studies are important because they impact the overall development pathway for an investigational product. Preclinical studies establish biological plausibility, dosage levels, safety, support patient eligibility criteria, and may identify potential public health risks.
Altogen Labs custom laboratory research services include:
- Over 50 validated xenograft models – link
- Transfection services, transient and stable – link
- Assay development (ELISA, RT-PCR, Western Blot) and library screening – link
- Pharm/tox and safety IND tests – link
- Generation of stable cell line in 28 days – link
- RNAi experiments (siRNA design, synthesis, validation) – link
- Gene targeting (mRNA knockdown, in vitro and in vivo RNAi validation) – link
- Liposome encapsulation service – link
- Other preclinical research services
Altogen Labs provides specialized biotechnology and pharmaceutical services, including generation of stable cell lines, gene silencing and RNA interference services, pre-clinical toxicology IND and other CRO services.