In vitro program
- 1. Contoso Ltd. In- vitro center In- vitro center In-Vitro Centre
- 2. Contoso Ltd. 2 Stability Center 2010 2012 2013 2014 2015 2016 2017 2018 2019 Health Canada Approval WHO(Geneva), ISO – 17025,Product Certification Center Bio Waiver Division Formulation Development Center Platform Technology Center Metabolism & Infection (AMR) Commerciali zation of Technology Clinical Supply Started Operation p Preservative free product Technology 2020 History
- 3. Contoso Ltd. 3 • Located in Bangalore, a dedicated cGLP Compliant research centre • Specialized in managing product quality process, upgrading and introducing advanced technology into products. we are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business • Established in September 2010 • Team experience spans across from design to concept, lab to commercialization of product and with competent technical experts • Automated Process driven and prepared for integration with partner site for transparency and real time access on each application Business Confidential Overview
- 4. Contoso Ltd. Audited and approved by WHO, Geneva 01 Accredited by ISO / IEC 17025:2005 (NABL) 04 Registered with DSIR 03 2 1 3 4 5 05 02 04 06 Approved by FDA (India) Registered with US FDA History 4
- 5. Contoso Ltd. 5 Professional Management with a strength of 100+ scientists Strong management governance Lean Organization - quicker decision Integration functional area expertise under one umbrella Easy to scale up or modify as most of process are automated State of art infrastructure Compliant with EHS regulations Infrastructure
- 6. Contoso Ltd. 6 Formulation & Development Bio waiver AMR - HTS Microbial Studies Platform Technology Product & Device Certification Centralized Stability Clinical Supply Referral lab & Turn Key Brand Services Suite
- 7. Contoso Ltd. 7 Consumer /OTC - Products Change Management Technology Migration Quality Assessment and Review Troubleshooting/Defect Analysis Pre – study Concept Design and Ideation Detailed Design and Analysis Final Design After Sales Performance Improvement Benchmarking Manufacturing Process Optimization Value Engineering Knowledge Based Engineering Design Automation Data and Model Recognition from Documents Product Lifecycle Product Sustenance Growth Solution Automation
- 8. Contoso Ltd. In Vitro Release Testing (IVRT) In Vitro Dissolution Absorption System (IDAS) 8 In-Vitro Dedicated Center In Vitro Permeation Test(IVPT) Biowaiver Studies Nasogastric and Gastronomy(NG) tube In vitro studies
- 9. Contoso Ltd. 9 Experience & Diversity – In-Vitro Business Segment Binding study IVRT In Vitro Release Testing IVPT In Vitro Permeation Testing Bio waiver IDAS Invitro dissolution absorption system Experienc e 5 years 5 years 5 years 3 years 7 years Dosage Solid, Liquid, Solid, Topical, Parenteral (Internal & External Application) Solid, Topical, (Internal & External Application) Solid, Liquid, Topical, (Internal & External Application) Solid, Liquid, Topical, Volume ( Annual) 5-10 5-10 5-10 10-30 10-50 Diversity Pharmaceutical Rx & OTC, Hygiene, Dietary, Compounding, Biological, Medical Device Pharmaceutical Rx & OTC, Hygiene, Dietary, Compounding, Biological, Medical Device Pharmaceutical Rx & OTC, Hygiene, Dietary, Compounding, Biological, Medical Device Pharmaceutical Rx & OTC, Hygiene, Dietary, Compounding, Biological, Medical Device Dietary , Pharmaceutical Rx & OTC Category Chemical, Enzyme, Peptide, Natural, Probiotics based products Chemical, Enzyme, Peptide, Natural, Probiotics based products Chemical, probiotics based products Chemical, Enzyme, Peptide, Natural, Probiotics based products Chemical, based products Market Asia, Australia, Africa, Canada, Middle east Asia, Australia, Africa, Canada, Middle east Asia, Australia, Africa, Canada, Middle east Asia, Australia, Africa, Canada, Middle east Asia , Australia, Africa, Canada, Middle east Experience & Diversity- In-vitro Business Segment
- 10. Contoso Ltd. IDAS offers the ability to measure Absorption Permeation Retention Control of biomarkers Metabolism Ability to test the finished dosage type from the tablet ,suspension to capsule Evaluate Formulations – Bioequivalence, Post Approval Changes Test the effects of food Formulations Assess GI Product Locally Acting 10 In-vitro Dissolution Absorption System (IDAS) In-Vitro Dissolution Absorption System(IDAS) Franz diffusion cell
- 11. Contoso Ltd. In-vitro are critical to drug and wellness product development due to their ability to provide a basis for clinical in vivo studies for predicting best delivery model to take Go/No-Go decision. Our solution studies on in vitro analyses can provide proof of concept on delivery dosage form in the early stages or reverse pharmacology development of the active process, when the selectivity and possible interactions of the candidate drug towards the desired therapeutic target are established Our team can provide solution map on case to case basis for your specific requirement 11 Proof of concept studies for development In-Vitro Program
- 12. Contoso Ltd. In-vitro are critical to drug and wellness product development due to their ability to provide a basis for clinical in vivo studies for predicting best delivery model to take Go/No-Go decision. Our solution studies on in vitro analyses can provide proof of concept on delivery dosage form in the early stages or reverse pharmacology development of the active process, when the selectivity and possible interactions of the candidate drug towards the desired therapeutic target are established Our team can provide solution map on case to case basis for your specific requirement 12 Proof of concept studies for development In-Vitro Program
- 14. Contoso Ltd. In-vitro release of API from topical and transdermal products, and subsequent permeation through a membrane, can be tested in a vertical diffusion cell (i.e. Franz diffusion cell) Membrane materials – synthetic polymer, tissue constructs 14 In-Vitro Release Testing (IVRT) Ophthalmic Topical
- 15. Contoso Ltd. In-vitro permeation testing (IVPT) studies across biological membranes for formulations that are applied to the skin or in the eye also to study drug accumulation in different layers of dermal or ophthalmic tissue IVPT Study Design: Research conditions optimization: analytical, receiver buffer, choice of time-point and dose quantity Validation of the analytical process Validation of the test procedure, including recovery, mass balance and dose depletion Qualification of the optimized assay parameters Comparison of pivotal bioequivalence with statistical assessment: parallel, single- dose, and multiple donors 15 In-Vitro Permeation Testing (IVPT)
- 16. Contoso Ltd. In-vitro Models are important as alternatives to animal & human testing and are key to efficacy & safety assessment activities In-vitro evaluation provides a complete suite of drug release assays and biowaiver studies for a variety of dosage forms ranging from simple tablets to transdermal formulations. As drug products continue to increase in complexity, there has been growing initiative to enhance evaluation by introducing the concepts of quality target product profile (QTPP) and quality by design (QbD) By complementing the traditional paradigm of ‘equivalence by testing’ the current framework encourages the use of appropriate surrogates to target pharmaceutical equivalence by design and it is accepted by regulatory also 16 In-Vitro Permeation Testing (IVPT)
- 17. Contoso Ltd. 17 In-Vitro Feeding Tube Studies Individual product specific bioequivalence guidance recommends In-vitro feeding tube studies for products such as oral suspension and capsules containing pellets, granules or beads This is prescribed for patients who have an underlying disease that makes it difficult to swallow or for intensive care patients Comparative recovery testing Particle size distribution study Comparative acid resistance stability testing & sedimentation volumne testing studies
- 18. Contoso Ltd. 18 Critical Control For – Strong Governance & Management Business Confidential Governance Board Governance board consist of both senior management from both sides is the final decision making authority Every quarter, partnership board should consist of senior review the level of collaboration and the performance Every year, partnership board conducts joint strategic technology planning sessions Relationship Management Day-to-day project management would be performed by dedicated relationship managers from each side Relationship managers will facilitate smooth project execution, define processes and act as trouble shooters Performance Management Performance tracking will be automated and Commitment tracker Clear definitions of success and failure Predefined processes for increased and decreased collaboration Exit clauses that define responsibility and timelines for knowledge transfer, documentation and intellectual property rights Best Practices Key Levers
- 19. Contoso Ltd. 19 Project Transition Plan – Details for Projects Knowledge Acquisition Project Planning Stabicon SimulationStabicon Training/Pilot Stabicon Execution 2 – 4 Weeks 1 – 2 Weeks 3 – 4 Weeks 2 – 3 Weeks Ongoing Establish Project scope, Expectations and Criteria for Success Set team composition, requirements and performance metrics Member of Stabicon team work with client to understand Document System/ Process Finalize transition plan Execution of project as per approved protocols Review and approval of reports by client Establishment of coordination team, process and metrics Program for Stabicon Complete fulfillment of projects request by Stabicon as agreed upon Service Levels Agreements Stabicon Transition Duration Description Client Staff FTE Off – shore Stabicon Staff FTE Project Stage
- 20. Contoso Ltd. 20 IN-VITRO WORK FLOW CHART In-Vitro Work Flow Chart
- 21. Contoso Ltd. www.stabicon.com bd@stabicon.com, info@stabicon.com +91 80 41250324 Business Development Team