New drug development generates a significant volume of samples in the research and development programs. Thus, pharma and biotech companies outsource their bioanalysis and associated studies to bioanalytical CRO to decrease cost and enhance time efficiencies.
CLINICAL RESEARCH ORGANIZATION (CRO) LAB
Clinical Research Organization (CRO) Lab is a service organization that offers support to the pharmaceutical and biotech cro companies in the mode of outsourced pharmaceutical research services for both drugs and medical devices. It is a relationship based on trust and skill.
CROs offer full service specializing in small and large molecule bioanalysis pharmaceuticals, generics, biologics, and vaccines in discovery and development stages. They can present their clients with the experience of moving a new drug or device from its conception to FDA marketing approval without the drug sponsor having to maintain a staff for these services. Data research, project management, trials, tests that happen post-approval, pre-clinical, and clinical are just a few of the activities covered.
NorthEast BioLab has a notable experience in PK sample analysis and TK safety testing utilizing mass spectrometric and chromatographic bioanalysis. Other bioanalytical CRO lab services consist of biomarker testing, cell-based assay, cytotoxicity assay, immunogenicity testing, biochemical assay, and Mechanism of Action (MoA) studies.
- PK – Pharmacokinetics (PK) describes drug behavior in the human body of administration to absorption, distribution, metabolism, and excretion from the body. It facilitates critical decision making on drug dosage and safety. By evaluating PK of a biological drug in different matrices, including serum, urine, plasma, and saliva, we can understand a drug’s interaction with the body and the intensity and duration of its efficacy.
2. Biomarker – Biomarker testing facilitates the measurement of biological response to therapy in an unhealthy or healthy body. We realize that accurate biomarker validation and qualification are essential to the transition of your drug or diagnostic device as biomarkers help make decisions concerning their continued development by assessing the efficacy, safety, and mechanism of action of drugs.
- Cell-based Assays – Cell-based assays use live cells to offer a more relevant representation of a real-life model, allowing for tracking dynamic variables such as the number of cells or their behavior. Cell-based assays are extensively used in drug discovery and development, as this method provides feedback from experiments with living cells. NorthEast BioLab offers custom cell-based assay method development and optimization to check your drug products’ potency or biological activity.
- Immunogenicity – Immunogenicity is a major concern for biologic drugs as it can affect safety and efficacy. Immunogenicity testing evaluates any undesirable immune response produced by a biologic like decreased efficacy or auto-immune, allergic, and anaphylactic reactions in the body.
NorthEast BioLab is a boutique clinical research organization (CRO) lab specializing in small and large molecule bioanalysis of pharmaceutical, biologics, generics, and vaccines in discovery and development stages. As a leading bioanalytical CRO pharma company, we have successfully applied our acquired experience and knowledge to deliver seamless operations for our clients. We have been focused on giving tailor-made research and development services and solutions to biotech and pharma companies.