Bioanalytical Services

Biocompatibility testing services (ISO 10993)Genotoxicity: Ames test (In vitro), Chromosomal Aberration (In vitro), Micronucleus Test (In vitro & In vivo), Mouse Lymphoma (In vivo).Cytotoxicity: Elution (MEM), Neutral red uptake (NRU) (In vitro), MTT-(3-(4, 5-dimethylthiazol-2-yl)-2, 5-diphenyltetrazoliumbromid) Test (In vitro).Implantation: Subcutaneous tissue and muscleSkin Sensitization: Guinea pig maximization testIrritation: Intracutaneous and skin irritationSystemic toxicity: Acute, Sub acute, Chronic & Sub chronic Haemo compatibility: Haemolysis, Compliment activation assay (C3A & SC5B-9), PT and APTT.

Sanzyme Ltd. focus areas Sanzyme intend to focus on certain activities and be best in that areas as they will be the main value drivers for our clients. Pharmaceuticals- ICH guidelines, Schedule YPesticides & Biocides- OECD, EP A, OPPTSMedical Devices-ISO 10993 Standards Bio-Lab Specialized services & carry out to our customers Long term studies Testing on rodents and non-rodentsAcute toxicityToxicokinetics and pharmacokineticsLocal toleranceSingle/repeated dose toxicityMedical device testingGLP compliantBioassaysAbnormal toxicity and pyrogen testingBreeding of animals for experimentation & supplyAnimal rooms equipped with cameras for monitoring the activities.

The other major advantage of Bio LDO over conventional LDO is the tremendous decrease in emissions of green house gases, thereby helping the users of bio LDO to become socially responsible organizations.

SERVICE AVAILABLE WITH COMPLETE INTERPRETATION

Being a client-centric organization, we are proficient in offering efficient Bioanalytical Services. The provided services are widely demanded for developing drug by conducting analysis and also for evaluation of drugs in preclinical samples and human trials.

To develop expertise in research design and statistical analyses appropriate to clinical research. To develop expertise in research design and statistical analyses appropriate to clinical research. The content of the program can be defined in a number of ways: the purposes of research, research design concepts, data collection methods, and statistical or analytical methods. The program provides concepts and methods that relate to the purposes of clinical research, clinical epidemiology, clinical trials, program evaluation, and technology assessment.

Immunogenicity assays for biosimlar and other biologics. ADA (Anti-drug antibody) and PK analysis

The assay development and screening group provides platforms to identify lead molecules in multiple therapeutic areas. This expertise includes validated and optimized cell line development services in line with assay requirements. LC-MS/MS Bioanalytical Support non-GLPBioanalysis of different tissues & Bio-Fluids- rodents

We have a long history in recombinant protein expression and have developed a wide array of solutions for proteins that are difficult to express.

Due to dedicated Clinical Professional and growth of product portfolios, monitoring of Bioequivalence studies from the manufacturers at times in the pharmaceutical business will be critical, IGRS Team shall begin to take up review of Protocol, Country specific RLD information. Monitoring of the study. Submission and Obtaining NOC from DCGI, Reviewing the final Report and submission to Agency.IGRS can represent the company and offer our services to ease this burden, whether this is in the form of day-to-day product monitoring including all activity to maintain till the product is dispatched from the desired location and report submission within company portfolio.

SpinoS has been devoting itself to promote ICH-quality clinical trial for multinational pharmaceutical industries. In order to advance the services for more comprehensive scopes in drug development, SpinoS established its bioanalytical laboratory with a new era of the company as a total solution provider from IND Phase I ~ III to post- marketing IV and BA/BE study. SpinoS Bioanalytical Laboratory is a contract laboratory and specializes in providing high quality and speedy bioanalytial services for streamlining the entire drug development. Not only the Lab analytical competencies are continuing promoted for efficiency and technical capability, but also the management system of the Lab is constantly insisted to be in compliance with international standards. SpinoS Lab bears the heritage of professional and service quality as part of SpinoS family, combining the advantage of decades of clinical experience and state-of-the-art analytical lab setup. It is now unique for pharmaceutical industries benefits in terms of all bioanalytical needs form the aspects of quality, efficiency and cost effectiveness. SpinoS lab is your best partner in bioanalytical service. Each and every project undertaken by our experienced and highly trained team is customized to your individual needs. Our team is easily accessible for progress communication throughout all phases of a project from sample receipt to issuance of the final report.

Provide quality Bio analytical services in rapid turnaround time.Development of protocols for Bio analytical method development, method validation.Develop and validation of Bio analytical methods far in advance.Method Development & Validation in various mediums like plasma (human, animals), whole blood, urine and Feaces.Partial development of Bioanalytical method validation transferred by Sponsor.Method transfer of drugs in biological matrix.Project management techniques to track and ensure that Bioanalytical projects are completed in the shortest time possible.Compliance with regulatory guidelines maintaining standards of excellence, efficiency & speed to meet the timelinesExperienced Research Scientists Team dedicated to each LC-MS/MS.Bioanalytical Report Preparation and Review maintaining full compliance with regulatory requirements.Ability to run 240 samples per day per machine, amounting to 72000 samples per month, with highly skilled and experienced Bioanalytical professionals.State of Art Bioanalytical Laboratory Equipment and Technology 6 LC-MS/MS Agilent QQQ 64602 LC-MS/MS (WATERS XEVO TQ & Quttro Micro)2 LC-MS/MS Sciex API 4000Fully automated 3 HPLCs with PDA and Dual wave length detection techniques (WATERS 2695)-20 C & -80 C deep freezersRefrigerated centrifuge, milli Q waterNitrogen generatorMicro balance SPE Solid phase extraction unit (Positive & Negative pressure) Other analytical equipments

Cytotoxicity Test Skin Sensitization Test (GPMT) Skin, Mucous Membrane Eye Irritation Studies Intracutaneous Reactivity Test Acute Systemic Toxicity Test Implantation Hemolysis Test Pyrogenicity Test