Mtr corporate

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Micro Therapeutic Research Labs Private Limited Science with Ethics INTEGRATED SERVICE PROVIDER FOR PHARMA & BIOTECH COMPANIES 1

Transcript of Mtr corporate

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Micro Therapeutic Research Labs Private Limited

Science with Ethics

INTEGRATED SERVICE PROVIDER FOR PHARMA & BIOTECH COMPANIES

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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

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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]

[email protected]