Innate immunity and hormone therapy exposes a new area of ...

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Dec 6, 2012 (4 years and 8 months ago)

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BUSINESS SENSITIVE

Battelle’s Research and
Technologies

Presentation to KRIBB

Dr. Joan F. Adams

Dr. Joyce Durnford

June 20, 2006

BUSINESS SENSITIVE


Life Science & Biotechnology


Battelle’s diverse biological research and
development activities range from basic research to
product development


Battelle recognizes the rapidly growing role of
biological technology in almost all areas of our
business


Battelle is expanding and integrating its already
significant activities in life sciences



BUSINESS SENSITIVE



Principal areas of emphasis in application of
biological sciences are:


Energy and fuels (renewable energy, biofuels,
hydrogen generation)


Environmental cleanup and maintenance


Healthcare and biosecurity, specifically

-
Infectious disease (particularly diagnostics)

-
Toxicology and biomarkers discovery

-
Biothreat detection and defense


Biomimetic materials and molecular machines
(for use in above applications)

Applications of Life Sciences at Battelle

BUSINESS SENSITIVE



Principal areas of emphasis in scientific and
technical capabilities


Microbiology & systems biology of microbes
(environmental, infectious agents)


Proteomics (strong technology development)


Genome sequencing at Joint Genome Institute


Mouse genetics facility (e.g. genetics of immune function,
infectious disease, biomarkers)


Nanotechnology: biomimetics and for biological
applications (materials, sensors, devices)


Preclinical and clinical (animal testing, BCL
-
3 facility,
clinical trials)


Medical device development and testing


Science and Technology Capabilities

BUSINESS SENSITIVE



Is carried out at :


National laboratories managed by Battelle: PNNL, Oak
Ridge, Brookhaven, NREL, INL


Co
-
located and other Battelle
-
owned facilities (e.g. Battelle
N.W. Toxicology Lab., BEST)


Battelle Columbus and West Jefferson laboratories



Approximately $300MM in Life Science R & D in
2005


Battelle Life Sciences R & D

BUSINESS SENSITIVE


Biotechnology R&D

BUSINESS SENSITIVE


Battelle Biotechnology

Battelle Columbus

Battelle Eastern Science Technology Center

BUSINESS SENSITIVE


Integrated Approach for Biotech Solutions

Biotech Labs

Staff

Facility
Resources

Microbiology

Biochemistry

Immunology

Molecular

Biology

Virology

BSL
-
3 Testing

Genomics, Gene
Expression, Proteomics

Detection, Threat
Definition

Bioengineering

Host
-
Pathogen
Interactions

Assay Development/
Refinement

Sample Collection,
Transportation

Client

Battelle Project
Manager

Capability
Areas

Biotech
Solutions

Client
Interface

BUSINESS SENSITIVE


Molecular Biology

The molecular (immunology focused) biology team provides
expertise in current nucleic acid and recombinant DNA
technologies for diagnostics, pathogen detection and
identification, and for biomarker development and analysis.
Services provided by this group include:



PCR and Microarray reagent development (multi
-
platforms)


Gene Expression / Analysis and support of developmental bioinformatics

platforms for Battelle and key clients


Recombinant DNA services


Vector Development


Cloning


cDNA library construction and screening


DNA sequencing







BUSINESS SENSITIVE


Cell Culture / Virology

Integrated with microbiology, molecular biology,
immunology, cell biology, pathology, zoology, and
aerobiology. This is not a stand alone group within
Biotechnology. Services this group provides include:



Viral propagation, in vitro inactivation studies, molecular detection
assays, vaccine efficacy, animal challenge studies, and viral genetic
engineering.


Development of molecular and immunological assays


Experience in working with broad range of viruses


In vivo & In vitro pre
-
clinical or clinical studies


Release and stability testing




BUSINESS SENSITIVE


Immunology

This group is utilized heavily (internally) by numerous
groups for general immunological support for diverse
government projects. Services provided by this group
include:

Immunoassay refinement/establishment and validation for:


Detection of immunoreactive signatures in environmental samples


Serological response to disease and vaccination (flow, cell assays,
microarrays, RT
-
PCR etc…)


Support for medical device development


Antibody characterization and production

-
Affinity/specificity determination and epitope mapping

-
Polyclonal, monoclonal, and single chain production


Tissue processing (extraction of samples/tissues to include
RNA/DNA) and culture










BUSINESS SENSITIVE


Microbiology

This group is also heavily utilized by different groups and
clients for general microbiological support. Efforts are
largely focused on sample collection and analysis for
government clients. Services provided by this group include:



Conventional and innovative microbial techniques for

-

Biodefense, environmental, food, clinical, and industrial
microbiology clients


Sample extraction method evaluation, development, and improvement


Culture and extract (sample) stabilization


Detection method evaluation and improvement


Novel decontamination method development and evaluation


Antimicrobial screening and evaluation




BUSINESS SENSITIVE


Biochemistry

This group has shifted from a predominant Process
Development focus towards a maturing Formulation support
approach. Services provided by this group include:



Formulation

-
Development of formulations for pharmaceuticals and vaccines

-
Stabilization of detection PCR and Antibody reagents and controlled
release of proteins

-
Development of small molecule formulations for agrochemical and
environmental applications


Process Development

-
Recombinant protein expression

-
Development and scale up of Protein Purification Processes

-
GLP protein purification for regulated animal testing

-
Manufacturing optimization

BUSINESS SENSITIVE


Understanding An Individual’s Health

Problem: Ability to associate
individuals with activities

Solutions:



Define markers of stress,
medical condition etc.



Define subpopulation
characteristics



Determine exposure indicators

BUSINESS SENSITIVE


Point
-
of
-
Collection Solutions

Problem: Sample degradation
and initial concentrations prevent
accurate detection

Solutions:



Extraction
-

Difficult matrices,
interfering substances



Processing
-

Sample
collection, concentration



Stabilization
-

Prevention of
sample loss, degradation

BUSINESS SENSITIVE



Areas for Advanced Discussion

Immune Modulators

Problem: Innate immunity and hormone therapy exposes a
new area of biological threats


Genetically Modified Threats

Problem:

Transfer of pathogenic elements to other organisms


Bioengineered Agent Defeat

Problem: Defeat agent production without signature

BUSINESS SENSITIVE



Biological Safety Level 3
(BSL
-
3) Facility


Continuous operation
since 1995


Animal rooms

-
9 BSL
-
3; 2 BSL
-
2

-
Rodent, rabbit, swine,
primate holding


Laboratories; 12 BSL
-
3, 8 BSL
-
2

-
Aerosol Exposure Laboratory

-
Microbiology, virology


30 x 96 ft. barn for large animals

Medical Research and Evaluation Facility


38,000 ft
2
BSL3 Space

Biofacility

Large Animal
Facility

BUSINESS SENSITIVE


Pharmaceuticals and
Medical Products

BUSINESS SENSITIVE


Pharmaceuticals


Focused on safety pharmacology and
metabonomics applications in


Cardiovascular


Respiratory


Central nervous system


Gastro
-
intestinal system


Renal


Strong toxicology capabilities


Strong analytical services and regulatory
compliance

BUSINESS SENSITIVE


Clinical Toxicology Capabilities


Oral


capsule and gavage


Dosed Feed and Dosed Water


Dermal
-

percutaneous toxicity, sensitization and skin
painting


Inhalation
-

nose
-
only, head only and whole
-
body
exposure


Intratracheal Instillation
-

unanesthetized guinea pig


Intravenous
-

bolus injection and short
-
term or long
-
term
continuous infusion


Other Parenteral Routes
-

intraperitoneal, subcutaneous,
intradermal, intramuscular and intraventricular


Species
-

rodent, canine, non
-
human primate, rabbit

and swine


Regulatory Compliance

Pre
-
Clinical Toxicology


BUSINESS SENSITIVE


Medical Device Solutions
-

Customers


Focus: Medical Device Industry



Company Type: Mature, Stable, and Start
-
up



Device Type: IVD, Clinical Laboratory Instruments, Drug
Delivery Devices, others



Device Class: FDA Class II and Class III or equivalent

Over the last 15 years we have performed over 350 programs
for 200 medical device companies

BUSINESS SENSITIVE


Medical Device Examples

BUSINESS SENSITIVE


EFET Product Platform

EFET Platform

Fiber Creation

Aerosol Creation

Pre
-
Manufactured
Fiber Mat

In situ

Fiber
Creation

Aerosol product

Aerosol process

Charged
aerosols

Discharged
aerosols

BUSINESS SENSITIVE


Encapsulated Active Ingredients

BUSINESS SENSITIVE


Leveraging EFET Technology

BattellePharma

Example of fiber generation

BUSINESS SENSITIVE


Cell
-
Based Manufacturing Issues


Current cell therapy processes are labor intensive
and expensive.


Conventional approaches established for the
production and delivery of drugs are not usually
adaptable to the needs of cell therapies.


The largely manual methods originally created by
the researchers who designed cell
-
based therapies
are not scalable to commercial levels


“Cell Processing” versus “Manufacturing”

BUSINESS SENSITIVE


What will be required?


A systems approach to problems solving that
includes the right mix of advanced engineering and
biomedical talent and capabilities.


A deep understanding of technology productization
& commercialization in multiple areas of medical
products (i.e., drugs, biologics, and devices).


Experience with regulatory requirements & trends.


Innovative manufacturing for commercial success.


What’s important must change


from “what’s
possible” to “a reduction to practice of what you
have.” That’s what ultimately counts!

BUSINESS SENSITIVE


Cell
-
Based Therapies


Lessons Learned


Each cell
-
based therapy is unique. One cannot use
a one
-
size
-
fits
-
all approach to manufacturing.


The process is the product.


Production methodology will change from pre
-
clinical to clinical to commercial delivery.


Don’t attempt to optimize stand
-
alone manufacturing
elements using laboratory experimentation.


In the context of manufacturing, cell process
development is not all biology and device design
controls are not all engineering.