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Chromcore Lifesciences: Integrated CRO for Inhalation Drug Delivery Systems

Chromcore Lifesciences is a full-service cGMP compliant laboratory specializing in analytical testing of inhaled drug delivery systems. We provide comprehensive solutions for inhalation dosage forms, from early-stage development to commercialization, with global regulatory expertise and extensive project management.

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Chromcore Lifesciences: Integrated CRO for Inhalation Drug Delivery Systems

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  1. PROJECT AND CAPABILITIES OVERVIEW

  2. About us Vision To be an integrated CRO with global distinction, aiming for long term partnerships with our customers based on shared benefits and goals for synergistic growth Innovation Quality work On Time & One time delivery Experienced Our Values Mission • At Chromcore, our mission is to deliver Value added, Reliable and cost effective services to our customers through our core values Good Service Professional Safety

  3. To ensure that our services adhere to the highest standards which are on par with global quality standards and setting new benchmarks . Quality Policy • To achieve sustained and profitable growth by providing services, which consistently satisfy the needs and expectations of customers • We believe that quality and compliance can be designed into processes. We believe in achieving quality standards in all that we do.

  4. Why Chromcore Lifesciences • Well defined Standard Operating procedures • Customer Focused Approach • Customer Satisfaction is our Goal • Uncompromising Commitment towards Quality • Professional and experienced workforce • On time delivery with quick turn around time • Cost effective • World Class Facility with highest quality infrastructure and instrumentation • Assured data confidentiality and integrity

  5. Chromcore Strength • cGMP compliant laboratory Chromcore is a full-service cGMP compliant laboratory specializing in analytical testing of a range of inhaled drug delivery systems. • Capabilities We provide comprehensive solutions for all the inhalation dosage forms from early stage of product development to commercialization and we can also provide support for post approval amendment filing process. Expertise Our scientists utilize the latest instrumentation and methodologies to provide customers with the highest quality of analytical research across all inhalation dosage forms( MDI’s, DPI’s, nebulizers, and nasal drug products). • Global regulatory expertise • Utilizing our global regulatory expertise, we will customize a program to meet your In-Vitro Bio- equivalence testing specific requirements • Project Management Extensive project management will ensure sponsor involvement and a smooth transition of data and documentation

  6. Infrastructure Biometric Access to critical areas, extensive sample management and security protocols to ensure data integrity Automation tools for Inhalation sample preparations to minimize variability and create an environment to provide consistent data and results. Multiple set ups of key instruments with complete, identical Inhalation research rooms in a state of the art controlled environment Strong IT infrastructure and multi layered back up systems and protocols 01 02 03 04

  7. Expertize in all delivery systems Metered Dose Inhalers • Nebulizers • NasalSprays • Dry Powder • Inhalers

  8. Tests For DPI’s SPECIFICATIONS FOR THE DRUG PRODUCT • Appearance and Colour • Identification (Primary and secondary) • Microbial LimitTest • Water or Moisture Content • Net Content (Fill) Weight (Device-metered) • Drug Content (Assay) • Impurities and Degradation Products • Dose Content Uniformity • Dose Content Uniformity Through Container Life (device-metered) • Particle Size Distribution of Emitted Dose • Microscopic Evaluation INNOVATIVE IN-VITRO TESTING • BRS 3000 -Improving IVIVCs for DPIs • Dissolution Testing with out using anatomical throat • Morphology • Surface area • Surface energy • Powder Rheology (FT4) • Particle Size and shape • Cohesive adhesive balance DRUG PRODUCT CHARACTERIZATION STUDIES FOR SUBMISSION • Determination of Appropriate Storage Conditions • Stability of Primary (Unprotected) Package • Effect of Varying Flow Rates • Effect of Storage on the Particle Size Distribution • Dose Build-up and Flow Resistance • Effect of Orientation • In Vitro Dose Proportionality • Effect of Patient Use / In-use stability (as per PIL) • Effect of Moisture • Photo stability • Profiling of Doses Near Device Exhaustion • Priming ( For Device metered) • Fill Weight • Device Ruggedness • Cleaning Instructions IN-VITRO BIO- EQUIVALENCE WITH STATISTICAL ANALYSIS (FOR SUBMISSION) • APSD (test and Reference) with critical stage PBE • Single actuation content (test and Reference) (SAC) with PBE • Q1-Q2 comparison

  9. Tests For MDI’s SPECIFICATIONS FOR THE DRUG PRODUCT • Appearance and Colour • Identification (Primary and secondary) • Microbial Limit test • Water Content • Dehydrated Alcohol Content • Net Content (Fill) Weight • Drug Content (Assay) • Impurities and Degradation Products • Foreign particulate matter • Dose Content Uniformity • Dose Content Uniformity Through Container Life • Particle Size Distribution • Aerodynamic particle size distribution • Microscopic Evaluation • Spray Pattern and Plume Geometry • Leak Rate • Pressure Testing • Valve Delivery (Shot Weight) • Leachables DRUG PRODUCT CHARACTERIZATION STUDIES FOR SUBMISSION • Determination of Appropriate Storage Conditions • Stability of Primary (Unprotected) Package • Temperature Cycling • Effect of Resting Time • Priming/ Re-priming • Effect of Storage on the Particle Size Distribution • Drug Deposition on Mouthpiece and/or Accessories • Cleaning Instructions • Profiling of Actuations Near Canister Exhaustion • Plume Geometry • Photo stability • Profiling of Doses Near Device Exhaustion • Microbial Challenge • In Vitro Dose Proportionality • Effect of Varying Flow Rates • Cleaning Instructions INNOVATIVE IN-VITRO TESTING • BRS 3000 -Improving IVIVCs for MDIs • Dissolution Testing with out using anatomical throat • Particle size and shape of API in formulation • Particle morphology IN-VITRO BIO- EQUIVALENCE WITH STATISTICAL ANALYSIS (FOR SUBMISSION) • APSD (test and Reference) with critical stage PBE • Single actuation content (test and Reference) (SAC) with PBE • Spray pattern • Plume geometry • Q1-Q2 comparison

  10. Tests For Nebulizers/ Inhalation solution and Suspension’s DRUG PRODUCT CHARACTERIZATION STUDIES FOR SUBMISSION • Determination of Appropriate Storage Conditions • Stability of Primary (Unprotected) Package • Temperature Cycling • Effect of Storage on the Particle Size Distribution • Photo stability • Droplet size distribution • Sterility • In Vitro Dose Proportionality • Drug delivery at 60s INNOVATIVE IN-VITRO TESTING • BRS 2000 -Improving IVIVCs for nebulizers • Breathing profile with face masks • Dissolution Testing with out using anatomical throat • Particle size and shape of API in formulation • Particle morphology SPECIFICATIONS FOR THE DRUG PRODUCT • Description • Identification (primary and secondary). • pH, Osmolality • Assay • Unit Dose Content Uniformity • Foreign particulate matter • Concentration of tonicity agent (if any) • Limit of chelating agent (if any). • Particle size distribution of drug in immediate container. • Related substances/ Degradation profile • Mean Nebulization time • Mean delivered dose • Aerodynamic particle size distribution • Sterility • Leachables IN-VITRO BIO- EQUIVALENCE WITH STATISTICAL ANALYSIS (FOR SUBMISSION) • APSD (test and Reference) with critical stage PBE • Polymorph form comparison • Particle size distribution • Particle shape • Uniformity of dosage unit • Droplet size distribution • Q1-Q2 comparison

  11. Tests For Nasal Sprays SPECIFICATIONS FOR THE DRUG PRODUCT • Description • Identification (primary and secondary). • pH, Osmolality • Valve Delivery (Shot Weight) • Assay • Unit Dose Content Uniformity • Foreign particulate matter • Concentration of tonicity agent (if any) • Limit of chelating agent (if any). • Droplet size distribution • Spray pattern and Plume geometry • Related substances/ Degradation profile • Sterility • Leachables DRUG PRODUCT CHARACTERIZATION STUDIES FOR SUBMISSION • Determination of Appropriate Storage Conditions • Stability of Primary (Unprotected) Package • Temperature Cycling • Effect of Storage • Droplet size distribution • Plume Geometry • Photo stability • Aerodynamic particle size distribution with suitable expansion chamber • Sterility INNOVATIVE IN-VITRO TESTING • Particle size and shape of API in formulation • Particle morphology IN-VITRO BIO- EQUIVALENCE WITH STATISTICAL ANALYSIS (FOR SUBMISSION) • Single actuation content (test and Reference) (SAC) with PBE • Droplet size distribution • Drug in small particle/ droplet • Spray pattern • Plume Geometry • Priming and Re-priming • Q1-Q2 comparison

  12. Services Reverse Engineering/ De-Formulation/ Q1-Q2 Analytical Method Development Actuator Screening Study Analytical Method Validation • Analytical Method Verification Analytical Method Transfer Supporting in Identifying Q3 Parameters For ensuring Bio-success Drug Product Characterization as per CMC Guidance Device Characterization RLD Lot selection for Biostudies Stability Testing Drug Product Characterization as per CMC Guidance Device Selection and Characterization Development & GMP Batch Analysis Drug Delivery Through Spacers In-vitro Bio Equivalence QC Batch Release

  13. Stability Services R&D stability Services Commercial Stability Services Market Extension Stability Services • Registration • Stability Services

  14. Brief Work Flow Testing & Reporting Coding & Sample Storage Data Sharing Project Code • Testing of samples against sample request form/ protocol & reporting • Coding &Sample storage in defined rack in the store (with bio-metric access) in controlled environmental condition Allotment of Project code • Preparation of the comprehensive study report with partner inputs and quality requirement Discussion with Client CDA Management of retention sample Sample Issuance • Mutual Confidentiality Agreement & Scope Document • Issuance of samples against sample request form/ protocol to the scientist • Management of leftover samples as per sponsor’s instruction and GMP requirements (i.e. Discard as per defined procedure/Ship back to sponsor with proper documentation or storage • as per study) Sample Consumption Record Sample Receipt • QA check and entry along with define quantity & Storage conditions • Sample consumption record along with each analysis (with proper QA check)

  15. Organogram

  16. Instrumentation List

  17. Instrumentation List

  18. Instrumentation List

  19. Instrumentation List

  20. State of Art Infrastructure

  21. For further enquiries Contact Us Address Cynosure plaza , 3th floor, Madhuranagar, Visakhapatnam 530016 Phone +91-9881499920 E-mail office@Chromcore.com Website • www.chromcore.com Contact us to arrange a visit to our lab

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