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Micro Therapeutic Research Labs Private Limited
Science with Ethics
INTEGRATED SERVICE PROVIDER FOR PHARMA & BIOTECH COMPANIES
MTR,Selaiyur
MTR,Coimbatore
MTR,Chrompet
MTR,Padi
MTR, Selaiyur, Chennai, IN Spread over 40,000 square feet of area CPU with 55 beds Bio-analytical lab with 12 LC-MS/MS and 1 ICP-MS instrument.
MTR, Coimbatore, IN Spread over 45,000 square feet of area CPU with 100 beds
MTR, Chrompet, Chennai, IN Spread over 25,000 square feet of area CPU with 125 beds Bio-analytical lab with 08 LC-MS/MS instrument
MTR, Padi, Chennai, IN Spread over 18000 square feet of area GLP compliant preclinical and biology lab
FACILITIES
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NAME AFFILIATION DESIGNATION YEAR(S) OF EXPERIENCE
Dr. M. Ganesan Scientist Managing Director 20
Mr. N. Sundar Finance Chief Operating Officer 22
Mr. Nishant Paliwal Scientist Sr. Manager –QA & Regulatory Affairs 10
Dr. D . Sridevi General Physician Head- Clinical 09
Mr. N. Medhavi Scientist Sr. QM- Diagnostics 19
Ms. R. Abiraamasundari Scientist Head- Project Management 08
Mr. S. Viswanathan Scientist Sr. Manager – Bioanalytical 12
Dr. K.Senthil Kumar General Physician Principal Investigator 04
Mr. Kathiravan. S Scientist Manager-QA 13
Mr. Ajay Mishra Scientist Asst. Manager-QA 09
Dr. Murthy Scientist Head-BA (Biosimilars) 17
Dr. G.Shanthi Scientist Manager -Preclinical 10
KEY PERSONNEL
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REGULATORY AUDITS & ACCREDITATIONS
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REGULATORY PHASES YEAR Location STATUS
ISO 9001:2000 Systems Audit 2006 Chennai Certificate receivedNABL System & Quality Audit 2008 Chennai Certificate received
US FDA Clinical audit 2009 Chennai EIR ReceivedDCGI Facility audit 2009 Chennai Facility approved
AFSSAPS (ANSM) Clinical & Bio Analytical 2010 Chennai Approval received US FDA Clinical & Bio Analytical 2010 Chennai EIR report receivedANVISA Facility Audit 2010 Chennai Approval receivedUS FDA Clinical 2011 Chennai No Findings
ISO 9001:2008 Systems audit 2011 Chennai Certificate receivedCAP System & Quality audit 2011 Chennai Certificate received
US FDA Clinical Trial 2011 Clinical Trial Site No FindingsWHO Clinical & Bio Analytical 2011 Chennai Approval receivedDCGI Facility Audit 2011 Coimbatore Facility Approved
ANVISA Facility Audit 2011 Chennai Approval receivedUS FDA Clinical 2012 Chennai & Coimbatore No Findings/EIR Received
ANVISA Facility Audit 2012 Chennai & Coimbatore Facility approved/Reapproved
ANSM/ BfArM Clinical & Bio Analytical 2013 Chennai Report ReceivedANVISA Facility Audit 2013 Chennai Report Received
DCGI Facility Audit 2013 Coimbatore & Chennai Facility ReapprovedCAP System & Quality audit 2013 Chennai Certificate received
NABL System & Quality Audit 2013 Chennai Certificate receivedNABL System & Quality Audit 2014 Coimbatore Certificate received
USFDA Clinical Trial 2014 Clinical Trial Sites EIR AwaitedDCGI Facility Audit 2014 Chennai Certificate received
REGULATORY AUDITS STATUS
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Biology
Bioavailability & Bioequivalence
Nonclinical
Clinical Research
SERVICES
SOURCINGVOLUNTEERS
SELECTIONOF VOLUNTEER
CONDUCTOF STUDY
Highly trained staff for:
Clinic Management Project/Data Management Regulatory Affairs Quality Assurance Timely delivery of projects with quality
280 beds facility across three locations
ICU facility with 13 beds across three locations
NABL/CAP accredited central diagnostic laboratory
Bio-waste segregation and management
Collaboration with hospitals for handling emergency
Pharmacy with temperature and humidity control
CLINICAL PHASE
BIOAVAILABILITY & BIOEQUIVALENCE
Female(3500 +)Male(20000 +)
Volunteer Data Bank (23500+)
Postmenopausal(1500+)
Menstruating(2000 +)
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DEPLOYMENTBIOANALYTICAL PHASE
INSTRUMENTATION NUMBER INSTRUMENTATION NUMBER
LC-MS/MS ( Waters Xevo TQMS, Quattro Micro Mass, API –5500,4000,3200)
20 SPEED VAC CONCENTRATOR FROM EPPENDORF
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ICPMS 01 48 POSITION POSITIVE PRESSURE
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GC-MS/HS 01 TURBO LV EVAPORATOR
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HPLC 02 REFIGERATED CENTRIFUGE
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DEEP FREEZERS (-20ºC)/(-40ºC)/ (-80ºC)
02/03/07 COLD ROOM 02
MTR has strong capabilities in bio analysis of small molecules. With its vastly experienced team and strong infrastructure, it
has validated bioanalytical methods for more than 200 molecules.
PHARMACOKINETIC, STATISTICAL & REPORTNG PHASE
Small Molecule Bio analysis
Pharmacokinetic and statistical analysis by using Winnonlin Pharsight version 5.3 and SAS version 9.2
Experienced medical writing team comprising Ph.D's and masters degree holders from elite institutes.
BIOAVAILABILITY & BIOEQUIVALENCE
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MTR is the First CRO in India audited by US FDA for studies conducted on special population (Post menopausal women)
Developed bioanalytical methods for challenging molecules like :- Omega Fatty acids Total Omega Lipids Estradiol & Estrone Vitamin –D3 /metabolite Total Iron Transferrin bound Iron
MTR is Pioneer to validate method for Nitroglycerin by LC-MS/MS
Experience:
MTR has successfully conducted over 1100
BA/BE studies
HIGHLIGHTS OF BIOAVAILABILITY & BIOEQUIVALENCE
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South Africa02 study
Canada
24 studies
United States
331 studies
Brazil
(ANVISA)
17 studies
Australia10 studies
Europe
EU/EMEA-63MHRA-3ANSM-3WHO-7
Germany-1studies
Russia 3 studies
No. of studies conducted – 1288No. of submission studies – 451
Studies conducted by MTR have been submitted by sponsors across the globe.
STUDY SUBMISSION
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Philippines 01
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CLINICAL OPERATIONS SERVICES
Conceptual Phase:• Feasibility evaluation• Protocol Synopsis preparation
Planning Phase:• Protocol and model ICF are
finalized• Sites are selected• Operations Manual completed• CRF’s are finalized• IRB Approvals are obtained• Contracts are finalized with
third party vendors• Database is built• Study drug packaging/labeling
is finalized
Implementation phase• Enrollment of subjects• Distribution of study drug to
sites• Protocol/CRF queries are
resolved• Incident calls are noted like;
SAE’s Dosage adjustments Premature withdrawals Drug Disclosure
• Data base is cleaned/closed• Database is transferred to
Biostatistics
Analysis and Publication Phase• Primary/secondary analysis is
performed• Manuscript is submitted• CTR is submitted
SPECIALIZED SERVICES
Central DiagnosticLaboratory Service
Pharmacogenomics
Successfully completed 20 Clinical trials which includes:-
12 trials in oncology 08 clinical trials in nutrition &
infection
CLINICAL RESEARCH
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PharmacogenomicsCentral DiagnosticLaboratory Service
SPECIALIZED SERVICES
NABL/CAP certified central diagnostic laboratory with advance infrastructure comprising:
Random access fully automated Biochemistry analyzer -Selectra ProM & Vitros 250
Fully automated Immunoassay analyzer Vitros ECiQ Chemi - Luminescence
Automated Hematology Cell Counter
ELISA reader LIMS for data sharing & reporting
MTR central lab has wide capability for analyzing different biomarkers.
Well-characterized phenotypic information will decide the class of drug and it’s PK property .It could also avoid the outliersin BA/BE study
Designing clinical trials to test for greater effects in specific subgroup
Genetic polymorphisms screeningof four FDA recommended drugmetabolizing enzyme screening is on going with in our volunteerdata pool. The screened enzymes are CYP2C9 CYP2C19 CYP2D6 SLCO1B1
CLINICAL RESEARCH
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Assay Biology
ADME/PK Pharmacology
Toxicology & Safety INFRASTRUCTURE
CPCSEA Approved
10000 Sq. Ft Vivarium
NONCLINICAL & BIOLOGY
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SYSTEMIC TOXICITY STUDIES
Acute
SubChronic
Chronic Toxicity
Carcinogenicity
SPECIAL TOXICITY STUDIES
Allergenicity test in Guinea pig
Genotoxicity
Toxicokinetics
Antibacterial activities
OECD Schedule Y EU EPA ISO ICH
REPRODUCTIVE TOXICITY STUDIES
Prenatal Developmental
One-Generation Reproduction
Two-Generation Reproduction
Reproduction- Developmental
Toxicity
TOXICOLOGY &
SAFETY
PRECLINICAL
TOPICAL TOXICITY STUDIES
Dermal Toxicity
Skin Irritation
Ocular Irritation
GENETIC TOXICITY STUDIES
AMES
Micronucleus Assay
Chromosomal Aberration
Regulatory Guidelines
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PRECLINICAL- PHARMOCOLOGY
• Dermatology ▪ Pain ▪ Infection ▪ Neurological• Cardiovascular Disorder ▪ Metabolic Disorder ▪ Safety Pharmacology
Pharmacology
• Cell Based Assay : ▪ Angiogenesis ▪ Immunocytokines ▪ Proliferation• Apoptosis ▪ luciferase reporter
• Target Based Assay : ▪ Kinase ▪ Gpcr ▪ Enzyme Assays ▪ Nuclear Receptor
Assay Biology
•Cytochrome P450 Assays ▪ CYP Induction ▪ CYP Inhibition ▪ CYP Isoenzyme•In Vivo PK ▪ Bioequivalence ▪ Formulation Development ▪ Mouse PK ▪ Rat PK•Solubility ▪ Aqueous Solubility ▪ LogP ▪ LogD ▪ pKa • Metabolic Stability ▪ Hepatocytes•Microsomes ▪ Plasma stability ▪ Protein Binding ▪ Equilibrium Dialysis ▪ Protein Aggregation ▪ Ultra Filtration Permeability ▪ Cell Permeability ▪ Intestinal Permeability
•Membrane Permeability ▪ Membrane Transporters
PK/ADME Assays
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BIOLOGY
INTEGRATED BIOSIMILAR DEVELOPMENT SERVICES
▪Cell line generation
▪Product characterization
▪Lot release testing
▪Bioassay and In vivo safety
▪Genetic stability
MICROBIOLOGICAL SERVICES
General Microbial Testing
Water and Food Analysis
Sterility Test
Pharmaceutical & Cosmetic Products
Microbial Limit Test
Minimum Inhibitory Concentration
Preservative Efficacy Test
Time Kill Assay
MOLECULAR BIOLOGY SERVICES
▪Cloning of target genes into vectors
▪Gene Knock in and knockout studies
▪Bacterial, Yeast, Baculovirus and mammalian expression system
▪Antibodies: Hybridoma, Polyclonal and recombinant
▪2D gel electrophoresis & Peptide sequencing
▪Purification of active proteins
▪Immunoblotting and Immunoassays
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IT: State of the art data centers across all facilities with latest hardware and software.
Best in class backup devices and procedures to ensure all time data security and redundancy.
Access controlled work environments with 24 hrs. surveillance measures.
Biometrics for personnel identification and access.
Highly secure infrastructure with latest and up to date security software and measures.
On-site : Chennai (Selaiyur) & Coimbatore
Off-site: Chennai (Oragadam)
Total area ~ 3000 sq.ft
Fire protection - With fire proof light and inert gas filler.
Archived Data Security - Fire proof compactors.
Data storage capacity- Electronic devices and Raw Data can be
stored in data safety cabinet for 15 years.
Archival
IT/ARCHIVAL
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State of the art Infrastructure with advanced instrumentation
Nationally and Internationally accredited laboratories
One Stop Centre for complete research services (Preclinical to Clinical trial)
Potential alliance and strategic partnership for cost effective development
Product Development & Regulatory Knowledge
Cross-disciplinary Expertise
ExcellentprojectManagementSystem
Committed to Our Client’s Success
WHY MTR
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CONTACT DETAILS
Corporate Facility:
Micro Therapeutic Research Labs Pvt. Ltd.Rajam Bhavanam, Door No. 6, Kamarajar Salai, Selaiyur, East Tambaram, Chennai- 600059, Tamilnadu, India
Tel No. (+91) 9444384232 / +91-44-22390070/71Fax No. (+91 44) 22390069
Preclinical & Biosimilars Facility:
Micro Therapeutic Research Labs Pvt. Ltd.Door No. 50&51, Balaji Nagar, 3rd Street, Padi, Chennai- 600050Tamilnadu, India
Tel No. (+91 44) 26541195Fax No. (+91 44) 22390069
Coimbatore Facility:
Micro Therapeutic Research Labs Pvt. Ltd. Door No.29 A, Krishna Madura Vanam, Vellakinar Pirivu, Thudiyalur, Coimbatore – 641029, Tamilnadu, India.
Tel No. +91 9442143923Fax No: +91 422 264 2492
Chrompet Facility:
Micro Therapeutic Research Labs Pvt. Ltd. Plot No. 46 (Part), Rengasamy Street, Chrompet , Chennai-600044,Tamilnadu, India Tel No. +919500152780 /
+919940502533
Contact us at: [email protected]