Diteba Research Laboratories Corporate Capabilities

Corporate Capabilities Presentation www.diteba.com

Who We Are
Founded in 2003
operating since October 2005
cGMP/GLP laboratory located minutes from Toronto Airport
State-of-the-art 10,000 sq. ft. facility
Licensed by Health Canada
as a GMP drug establishment
for Controlled Substances, Drugs and Precursors
Registered with U.S. FDA
Expertise in both small and large molecules

What We Offer
Analytical R&D Services
Bioanalytical Services
QC Release Testing
Stability Testing
Physical Testing
Analytical Support for Formulation Development
Cleaning Validation and Verification Testing
In Vitro Release Rate Testing Services

What We Offer
We are committed to the success of our clients through the acceleration of their R&D intensive projects
Diteba is uniquely positioned to deliver the R&D services and acumen our clients demand with our
Team of industry experts
World-class pharmaceutical laboratory
Comprehensive laboratory informatics infrastructure
Extensive academic network
We strive to be an innovative and cost effective partner that delivers consistent and quality services with unmatched integrity

What We Offer
Senior scientific staff offers impeccable credentials and experience in areas of:
cGMP Analytical Testing
GLP Bioanalytical Testing
Biologics Testing
In Vitro Release Rate Testing
Custom designed and built laboratory with state-of-the-art instrumentation
Operational design and efficiencies allow for flexibility and responsiveness
Complete e-lab informatics infrastructure to electronically capture and store all data that is 21 CFR Part 11 compliant

What We Offer
Senior scientists are involved directly with projects provides for:
Demonstrated creative, proactive approaches to solve the most complex technical challenges
Individualized approach with quicker turnaround times
Highly Responsive
Maintain available capacity for scheduling flexibility
Friendly attitude
Cost-effective solutions to reduce overall costs and improve processing times

Our Organization

Management and Key Personnel
Dr. Theo Kapanadze, D.Sc., Ph.D., Chief Scientific Officer, Executive VP Science
More than 30 years experience as an academic researcher, university professor and leading research scientist at major pharmaceutical and CRO companies
Has worked extensively in areas such as:
Pharmaceutical research and development
BA/BE and drug interaction studies
Led projects that provided analytical support for:
Formulation development
Toxicology & clinical programs
Stability studies
Over 16 semisolid In Vitro Release Testing projects (SUPAC-SS)
Credited with over 40 publications

Dr. Steve Li, M.D., M.Sci. (Pharm), Manager of Laboratory Operations
More than 20 years of research experience in the fields of:
Biomedical research
Clinical pharmacology
Biotechnology
Has worked extensively in:
Method development and validation
Stability support
Cleaning validation
Credited with over 35 publications and awards

Slavica Mogic, MSc., BSc., Manager of QA & RA
Scientific strength is in the knowledge of biomacromolecules, including methodologies utilized for the analysis of proteins, enzymes and immunoglobulins
Over 15 years of industry QA/RA experience gathered in Global bio/pharma companies and leading CRO’s in the areas of:
Raw material testing
Finished product release testing
Stability testing
Analytical method development and validation
Has knowledge of regulatory guidelines such as:
Health Canada
U.S. FDA
EMA
ICH Guidelines

Regulatory History DATE REGULATORY AGENCY CATEGORY RATING/Status Sep 2005 Health Canada Pharmaceuticals C (Compliant) July 2006 Health Canada Control Drugs and Substances Status: licensed Feb 2008 Health Canada Biologicals; Pharmaceuticals C (Compliant) Feb 2009 Health Canada Class A Precursors Status: licensed Mar 2010 Health Canada Biologicals; Pharmaceuticals C (Compliant)

Analytical R&D Services
Method development and validation for:
Drug substances and intermediates
Raw materials and excipient ingredients
Drug products
Stability-indicating methods
Forced degradation studies
Impurities & degradation
Equally adept at small or large molecules

QC Release Testing Services
Characterization or release testing of:
Raw material compendial testing
USP/NF, EP, JP
Impurity, Metabolite and Degradation Product Identification
Reference materials
CTM supplies and comparator products
In-process lots
Commercial finished product release
Controlled substances and precursors

Physical Testing Services
Loss on Drying, ROI
Moisture (Karl Fisher Titration & Coulometric)
Color Determination
Deliverable Volume
Density & Specific Gravity
Disintegration
pH and Conductivity
Product & Package Appearance
Tablet Hardness & Friability
Viscosity, Osmolarity, Particulates, TOC

Bioanalytical Testing Services
Custom Assay method development and validation
Pre-clinical animal and human clinical trials sample testing
Healthy patient/volunteer samples
Infectious populations samples
Sample analysis technologies in multiple biological species and matrices for preclinical animal studies
Bioanalysis of drug and metabolites in biological fluids
Clinical trials support (TK, PK, BA/BE, Drug Interaction)

Bioanalytical Testing Services
Expertise in many proven validated methods to measure all types of small or large molecule compounds using:
UPLC/MS/MS
HPLC - GFC
UPLC – UV, FI, ECD
Capillary and Gel Electrophoresis
Gel Image analysis
ELISA assays
DNA hybridization
Metabolite identification using LC/MS/MS
Ultra-Low freezers with generator back-up for storage
All work completed under GMP & GLP guidelines

Formulation Development Testing
Vehicle compatibility testing
Solubility testing
Excipient compatibility studies
Bench level formulation development contract services available
Feasibility batch testing:
Assay
Content and blend uniformity testing

Stability Testing Services
IND, NDA, ANDA Registration batches
CTM batches and comparator products
Commercial product
Controlled substances and precursors
Formulation evaluation stability testing
Forced degradation studies
Photo stability (UV and Daylight) per ICH Q1B
Temperature cycling (freeze/thaw)
Transportation studies
Protocol design and report writing

Stability Storage Services
Long-term and accelerated storage conditions per ICH Guidelines:
25 o C/60% RH
30 o C/65% RH
40 o C/75% RH
5 o C, -20 o C, -80 o C
Special storage conditions available
Stability chambers on automated generator back-up

Dissolution and In Vitro Release Testing
Method development and validation
Immediate and controlled release testing
Testing per USP monograph articles
Content uniformity testing
Drug release testing

Semisolids In Vitro Release Testing
In Vitro Release Testing (IVRT) of semisolids and transdermals using Franz Cell system
Conforms to FDA Scale-up and Post Approval Changes for Semisolids Guidelines (SUPAC-SS)
Conforms to USP Pharmacopeial Forum Vol. 35(3) May - June 2009 Product Quality and product performance tests for topical and transdermal products
Defined product quality tests in General Chapter <3>
Defined product performance tests <725>

Semisolids In Vitro Release Testing
IVRT testing valuable for:
In-process testing for formulation optimization
QC on lot-to-lot variability
Comparison testing for pre and post-change formulations
Skin penetration studies
Full method development and validation of IVRT and HPLC/UPLC assay methods
Preparation of data interpretation and submission reports

State-of-the-art instrumentation including:
HPLC
UPLC, UPLC-MS/MS
GC
AA
UV, FT-IR
Dissolution systems
Franz Cell and Enhancer Cell systems
ELISA readers
Capillary & Gel Electrophoresis
SDS-Page EP
TOC
Stability chambers
Physical testing equipment
Key Equipment

State-of-the-Art Laboratory Infrastructure
’ .
HPLC, UPLC, UPLC/MS GC EMPOWER Database ELN- TBD SDMS: NuGenesis Database UV, TOC, FTIR, AA, ELISA & Other applications without Database NuGenesis can also capture files from various applications that do not have their own database Final document for submission to client by Web access (in development) or in paper format. Balances & pH meter MS Office applications Temperature and Humidity Monitoring system for Stability Chambers by Rees Scientific

Key Partnership: Thesis Chemistry
Analysis and separations
Custom preparations
Process chemistry development
Chemical synthesis and manufacturing
CMC development
Commercial scale production

Key Partnership: Thesis Chemistry
cGMP compliant
Glass reactors: 2-L to 72-L
Pressure vessels: 4-L & 20-L
20-L rotary evaporators
Dedicated gowning area
Dedicated chemical storage area
HEPA filtered isolation room
Tray and vacuum ovens
Water filtration system

Our Experience Methods Developed in the Last 36 Months

Our Experience Recent Analytical Projects
Humanized mAb for oncology therapy
Method development & validation, release testing for CB, PK & TK bioanalytical studies, stability of CTM batches
Small molecule for cardio-protection therapy
Method development & validation, impurity characterization, TK & PK studies, Phase I & III bioanalytical studies
Oligonucleotide drug product for blocking P-53 apoptosis in oncology treatment
Method development & validation, stability of CTM batches
Recombinant single fusion protein drug product (86 KDa)
Complete peptide mapping by UPLC-UV and UPLC-MS-MS
Clotrimazole analog for oncology treatment
Formulation support, method development & validation, pre-clinical tox bio-analytical, stability of API & product

Our Experience Recent Analytical Projects
Multiple antigens used in biomarker assay kits
Method development & verification of multiple methods for QC of assay kits Transfer methods to kit & instrument manufacturer
Anti-retroviral microbicide for HIV treatment
Method development & validation, dissolution studies, stability testing
Aerosol fentanyl pain relief product
Method development & validation, In vitro release studies
Aerosol bucchal insulin product
Method development & validation, raw material compendial testing
Toll-like receptor (TLR) blocker for autoimmune therapies
Method development & validation, Phase I bioanalytical trial samples
Multiple raw material characterization for large biotech
Dozens of compendial tests for characterization and release

Our Experience Recent Bioanalytical Projects
Determination of a vitamin B metabolite and two other primary vitamers in human plasma by UPLC/HPLC with post column derivatization and fluorescence
Determination of an oncology compound in rat and dog serum by UPLC with UV Detection
Determination of humanized mAb in monkey and human serum by ELISA
Determination of caffeine in human plasma by LC/MS/MS
Determination of ASA & SA in rat by UPLC/MS/MS

Our Experience Recent In Vitro Release Testing Projects
Liposome encapsulated analgesic for pulmonary inhaled delivery
Comparison study between Franz cell and Enhancer cell techniques for the calculation of drug release
Anti-retroviral microbicide for HIV prevention (vaginal capsule suppository)
IVRT study for a reliable QC method to discriminate release characteristics in lot to lot uniformity and discriminate formulation changes
Anti-retroviral microbicide for HIV prevention (vaginal gel)
IVRT study comparing Franz cell vs. Enhancer cell techniques for best IVRT methodology
Developed and validated IVRT and HPLC assay methods
Vaginal cream
Developed and validated IVRT method for comparison study for site transfer
Study for FDA approval and SUPAC related changes

Thank you!

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Diteba Research Laboratories Corporate Capabilities

by Diteba Research Laboratories Inc. on Mar 30, 2011

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Diteba Research Laboratories Corporate Capabilities — Presentation Transcript