Advinus has re-launched its services for clinical sample analysis. Backed by our GLP accreditation and 11 years history of bioanalytical method development, validation and sample analysis, Advinus clinical bioanalysis of human samples, along with our other capabilities, extends our service platform from preclinical to early clinical development.

The Advinus Bioanalytical team has excellent scientific capability and experience. It has a proven track record of serving Large Pharma and Biotech for their non-clinical and clinical bioanalytical needs. Data can also be turned-around within 72 h of receipt of samples (along with preliminary PK analysis, if required) to support exposure-guided dose escalation studies. All logistics are project-managed and we assure you hassle-free service of importing clinical trial samples into India. Studies are performed in accordance with USFDA and EMEA bioanalytical guidelines.

Briefly, we can:

• Develop and validate new analytical methods for NCEs using state-of-the-art LC-MS/MS & HPLC instrumentation and achieve sensitivity up to pg/mL levels.
• Validate an existing method already developed in another lab for application to study sample analysis.
• Quantify clinical trial samples for analyte and or metabolite(s) for Phase-I through Phase-III trials.
• Offer bioanalytical services for novel biologics and biosimilars using ELISA platforms.

For detailed information, read bio analytical services.

Advinus has broadened its scope of services through the introduction of in vitro Skin Irritation (OECD 439) and in vitro skin Corrosion tests (OECD 431). These in vitro tests will be assessed using the Human 3-Dimensional EpiSkin®test kit. The tests have been validated in our laboratory by employing the OECD Guideline mandated proficiency substances. The in vitro EpiSkin® tests are routinely used for cosmetic raw materials and cosmetic formulations. In addition, current OECD guidelines for in vivo (whole animal) skin irritation tests mandate that prior to testing in animals all agrochemical and industrial (REACH) chemicals must be evaluated by employing in vitro tests. These tests are offered both under GLP for regulatory submission and also under non-GLP for screening in the research mode. Both in vitro EpiSkin® tests can be taken up in one week following supply of the compound and results can be provided with a week.

Advinus is a pioneer in toxicology testing including for nutraceuticals. We have conducted a number nutraceutical testing for global clients who have submitted our data/reports to US FDA who have accepted them without any reservation. In addition, Advinus is the only lab in India which has been successfully inspected by US FDA twice for GLP compliance. Our nutraceutical development services include but not limited to process development and synthesis, safety assessment, Analytical R&D, Metabolism and Pharmacokinetics (DMPK) and Bioanalysis.

Advinus Therapeutics Ltd., the TATA promoted Pharmaceutical R&D Company, announced today that it has reached the third milestone in its research and development collaboration with Takeda Pharmaceutical Company Limited. The achievement of this milestone highlights the success of the collaboration.

In October 2012, Advinus and Takeda announced a multi-year, multi-project collaboration in the area of drug discovery. In this collaboration, Advinus is responsible for carrying out all the research required to identify candidate molecules for clinical development in several therapeutic areas while Takeda is responsible for the development and commercialization of these candidates. In each of the previous two years, Advinus has met predetermined milestones. The achievement of the third milestone underscores the rapid progress of the research programs over the past year, a result of the innovative solutions and the speed and quality of Advinus’ efforts supported by Takeda’s guidance and highly interactive engagement.

“The achievement of the third milestone by Advinus’ young and talented scientists is a clear demonstration of how an effective partnership could deliver novel and effective candidates for drug development in a cost effective manner,” said Kasim Mookhtiar, CEO & MD of Advinus.

About Advinus

Advinus Therapeutics is a research based Pharma Company promoted by the TATA group. The company is the first of its kind in India to offer end to end development services to the global Pharma, Agro and Biotech industry while creating long term value through internal and collaborative Drug Discovery. The primary focus of the company’s discovery efforts are in Metabolic Diseases, Inflammatory Diseases and Pain/ Neurodegeneration. Advinus also has an interest in pursuing the discovery of novel therapies for neglected or developing world diseases. Advinus’ drug development operations supports and supplements the client resources at increased levels of cost-efficiency by providing services in the areas of Process Development, Drug Metabolism and Pharmacokinetics, Clinical Pharmacology, Safety Assessment, Formulation Development and Analytical R&D.