Loading presentation...

Present Remotely

Send the link below via email or IM

Copy

Present to your audience

Start remote presentation

  • Invited audience members will follow you as you navigate and present
  • People invited to a presentation do not need a Prezi account
  • This link expires 10 minutes after you close the presentation
  • A maximum of 30 users can follow your presentation
  • Learn more about this feature in our knowledge base article

Do you really want to delete this prezi?

Neither you, nor the coeditors you shared it with will be able to recover it again.

DeleteCancel

ZeptoMetrix Presentation 3.2015

No description
by

ZeptoMetrix Marketing

on 14 May 2015

Comments (0)

Please log in to add your comment.

Report abuse

Transcript of ZeptoMetrix Presentation 3.2015

FRANKLIN, MA
RUO and FDA Registered Manufacturing Facilities
Distribution and Fulfillment Services, BioRepository

26,500 sq. ft., 2 Facilities, 45 Team Members
cGMP Compliant Manufacturing & Clinical Sample Repository
cGMP Compliant Testing Laboratory
ISO 13485:2003 Certified
FDA Registered Blood Establishment
Molecular Diagnostics Division
- FDA Establishment License (IVD/CE)

BUFFALO, NY
Corporate Headquarters (Buffalo-Niagara Medical Campus)
Research & Development, Analytical Service Testing,
Raw Material Manufacturing and Finished Manufacturing

33,000 sq. ft., 3 Facilities, 50 Team Members
2 large Manufacturing Scale, Biological Level 3 Plus Laboratories
cGMP Compliant Manufacturing and Service Testing (Q4, 2014)
ISO 13485:2003 Certified
CDC Select Agent License
USDA Select Agent License

An Industry leader and innovator in
Infectious Disease Diagnostic Development,
ZeptoMetrix™ Corporation (ZMC) is a fully integrated Biotechnology Company whose Products, Services
and Global Solutions support all phases of
Research & Development, Assay Validation & Verification,
Quality Control, Service Testing, Manufacturing, BioStorage, Regulatory Submissions and Test Kit Commercialization.

From conception to launch, our goal is to provide cohesive, sustainable and cost effective answers to tomorrow's infectious disease diagnostic needs today.

NATtrol™ Molecular Controls
Background:
1999 HIV, HCV, HBV Bloodscreening External Run Controls

Theory :
Microorganisms require discrete Surface Protein Receptors to bind to and penetrate a host cell.

Hypothesis:
When we modify those Surface Proteins such that the Microorganism can no longer bind to a host cell, then the Microorganism should become noninfectious
and…
When we modify those Surface Proteins without damaging the inner Nucleic Acids, then the modified Microorganism should still function in a Molecular based Assay.

Conclusion:
Two highly controlled Biomedical Procedures are used to modify the Surface Proteins and render the Microorganism noninfectious.

Infectious Disease Research Solutions
878 Main Street, Buffalo, NY 14202 – Corporate Headquarters
872 Main Street, Buffalo, NY 14202 - Biological Laboratories - Research & Development
847 Main Street, Buffalo, NY 14202 - Analytical Service Testing and Finished Manufacturing
716-882-0920
25 Kenwood Circle, Suite 6, Franklin, MA 02038/Manufacturing, Distribution and Fulfillment
25 Kenwood Circle, Suite 9, Franklin, MA 02038/Molecular Diagnostics Division
508-553-5800

www.zeptometrix.com

Gregory R. Chiklis, Ph. D.
President and Chief Operating Officer
chiklis@zeptometrix.com

Karuna Sharma, Ph. D.
Senior Director & Chief Science Officer
karuna_s@zeptometrix.com

Peter Trabold, Ph. D., MBA
Director, Business Development
peter_t@zeptometrix.com

Michael A. Hershfield
Director, Sales & Marketing
mhershfield@zeptometrix.com

NATtrol™ Product Highlights
Intact Microorganism
Works across all Assay Platforms
Process is viable for Viruses, Bacteria, Fungi, Parasites and Bacteriophages
Matrix mimics a True Clinical Specimen
Contains the entire Microorganism Genome not Synthetic Sequences of RNA/DNA

Full Process
Controls for all Processes involved with the Extraction & Amplification of the Microorganism

Non-Infectious & Refrigerator Stable
Inactivation is Verified in Validated Growth Protocol
Ready to Use
Shipment on Gel Packs/Reduced Shipping Costs

Purified Microorganisms (Viruses, Bacteria, Fungii) and
Derivatives (Sucrose Purified, Titered Culture Fluids, Lysates, Purified DNA/RNA)
Serum Spiked Organisms for Regulatory Studies.

Virology and Microbiology Service Laboratory, Infectivity Validations, Growth Studies, TCID50, Custom Projects

BIOSTOR™ BioRepository containing >1,000,000 samples (Disease State Samples, Normal Human Serum, Cancer Markers, Chemistries, AutoImmune, Pregnancy (1st, 2nd and 3rd Trimesters)

Seroconversion Panels - HIV, HBV, HCV and EBV

ELISA Kits - HIV p24 Ag, SIV, HTLV, Human, Mouse & Bovine IgG, IgM

Western Blots - HIV, SIV, HTLV, I/II, Helico Blot 2.1

Research and Development, Feasibility and Assay Validation
Manufacturing Support
Bulk Disease State and Normal Human Plasma and Serum

Dilutional Base Matricies for Serology, Antigen and Molecular based Assays (Natural and Synthetic)

Sample Collection Solutions

OEM Control and Calibrator Formulations (Serology or Molecular): Bulk or Finished Vials

In Process and Final Product Release Panels
Assay Verification and Quality Control
CLIA Validation Panels for Serology (SeroDetect) and Molecular Platforms (NATtrol™ ). Sensitivity/Specificity , Range Validation and Interfering Substance Panels

NATtrol™ External Run Controls for Molecular Testing of Viral, Bacterial and Fungal Markers (Multiple Species and Concentrations)

Rapid Test Controls for Serological and Antigen based Assays

Sample Management and Distribution/Specimen Archiving and Processing
WHO/FIND Worldwide TB/Tropical Infectious Diseases
Regulatory Submissions
Laboratory Service Testing Division
cGMP/GLP Assay Validation and Verification Studies
Test Kit Commercialization
Marketing, Training, Proficiency and Reference Panel Development
Proficiency Panels
OEM Panels (2014: >80 International Programs, >60,000 kits distributed globally)
BIOSTOR™ BioRepository and Fulfillment Services
NATtrol™ Product Highlights
Calibration
Traceable to WHO International Standards (if available)

1-2 Year Stability
Superior Shelf Life
Multiple Re-Use Capabilities

Flexible Availability
Individual or Multiplexed Controls

Broad Patent Coverage
Protected Technology

Currently Available Viruses
Adenovirus
Astrovirus
Banzi
BK
Bovine Leukemia
Bovine Viral Diarrhea (BVDV)
Chikungunya
Coronavirus
Coxsackievirus
Cytomegalovirus (CMV)
Dengue
Echovirus
Enterovirus
Epstein-Barr (EBV)
Hepatitis A (HAV)
Hepatitis B (HBV)
Hepatitis C (HCV)
Herpes Simplex (HSV 1, 2)
Human Herpes (HHV6, 7, 8)
Human Immunodeficiency (HIV)
Human Metapneumovirus (hMPV)
Human T-lymphotrophic (HTLV)

Ilheus
Influenza A
Influenza B
Measles
Minute Virus of Mice (MVM)
Mouse Hepatitis (MHV)
Mouse Mammary Tumor (MMTV)
Mumps
Parainfluenza
Parechovirus
Respiratory Syncytial (RSV)
Rhinovirus
Rotavirus
Rubella
Saint Louis Encephalitis (SLEV)
Severe Acute Respiratory Syndrome (SARS)
Simian Immunodeficiency (SIV)
Varicella Zoster (VZV)
West Nile (WNV)
Yellow Fever
Zika
Currently Available Bacteria, Fungi, Parasites and Bacteriophages
Acinetobacter
Actinomyces
Aspergillus
Bacillus
Bacteriophage Lambda
Bacteriophage MS2
Bacteroides
Bifidobacterium
Bordetella
Brucella
Burkholderia
Campylobacter
Candida
Chlamydia
Citrobacter
Clostridium
Corynebacterium
Cronobacter
Cryptococcus
Cunninghamella

Entamoeba
Enterobacter
Enterococcus
Escherichia
Francisella
Fusarium
Gardnerella
Haemophilus
Helicobacter
Klebsiella
Kocuria
Lactobacillus
Legionella
Listeria
Micrococcus
Moraxella
Mucor
Mycobacterium
Mycoplasma
Neisseria
Nocardia

Prevotella
Proteus
Pseudomonas
Rhizobium
Rhizopus
Rothia
Saccharomyces
Salmonella
Scedosporidium
Serratia
Shigella
Sphingomonas
Staphylococcus
Stenotrophomonas
Streptococcus
Toxoplasma
Tremella
Trichomonas
Vibrio
Yersinia

Recombinant Controls
Blastomyces dermatitidis, assay specific
Coccidioides immitis, assay specific
Coronavirus HKU, assay specific
Cryptosporidium parvum, assay specific and native organism control is in development
Cyclospora cayetanensis, assay specific recombinant in development
Escherichia coli, O157, assay specific
Giardia lamblia, assay specific and native organism control is in development
Histoplasma capsulatum, assay specific
Norovirus group I
Norovirus group II
Pneumocystis jiroveci, assay specific
Sapovirus, assay specific recombinant in development
stx1 and stx2, can be exported out of the US, assay specific
Vibrio cholerae, can be exported out of the US, assay specific

Sampling of NATtrol™ Molecular Controls
GI
EBV
CT/NG
CXV
VZV
HCV
RVP
HIV
c. Diff
BC/GP
MRSA
HSV1
HSV2
GBS
BK
FLU A/B
H1N1 (2009)
CMV
BC/GN
ZeptoMetrix™ Notes
Select Agent Regulations Exemption
SARS-CoV---Select Agent as of 12/4/2012.

In February 2013 the Centers of Disease Control and Prevention (CDC), Division of Select Agents and Toxins (DSAT) has determined and approved an exclusion for ZeptoMetrix Corporation’s NATtrol™-treated SARS-CoV Molecular Controls from the Select Agent Regulations, including those regarding the possession, use and transfer of select agents (42 C.F.R. 73 and 9 C.F.R. 121).

Commerce Control Listings Exemption

MRSA EAR 99

In March 2014 the United States Department of Commerce determined and approved an exclusion for ZeptoMetrix Corporation’s NATtrol™-treated MRSA Molecular Controls from the Commerce Control List.
Controls may now be shipped under EAR 99.

Other Organisms also excluded include SARS and various NATtrol™ treated organisms.

ZeptoMetrix™ Corporation
Product Development
Custom and OEM Research | Design & Development | Assay Development
Bulk Manufacturing | Component Manufacturing | In-Process QC Materials
Custom Microorganism Propagation | Proficiency, Validation & Verification Panels

Testing Services
Inactivation | Infectivity | Sterility | Stability

Analytical Studies
LOD | Specificity | Cross Reactivity | Interference | Stability
Assay Precision | Range Validation | Assay Validation & Verification

Fulfillment Services
Assembly | Secure Storage | Distribution

BIOSTOR™ Repository
Sample Management and Distribution | Specimen Archiving and Processing

ELISA Design, Development and Validation Testing

ZeptoMetrix™ Corporation
Full transcript