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AKRON BIOTECH Claudia Zylberberg, PhD. CEO CAR-T 2017
AKRON BIOTECHClaudia Zylberberg, PhD. CEO
CAR-T 2017
An innovative company that develops, manufactures and markets ancillary materials and novel products/tools under cGMP compliance for tissue, cell and gene therapies serving the regenerative medicine industry from development to bedside
AKRON Biotech
Smart solutions for better cures
The Fourth Industrial Revolution: Industry 4.0
Industry 1.0“Mechanization”
Industry 2.0“Electrification”
Industry 3.0“Automation”
Industry 4.0“Autonomization”
MicroscopyCell visualization
Shaker scale up division of labor and electrical
energy
Automation of production with
electronics and IT
Cyber physical production based on
the internet of things & services Data/analytics
1784
first mechanical loom
1870first conveyor belt
1869first programmable logic
controller (PLC) internet and
interconnectivity
1800 1900 1970 today
Definition of Key Terms
Internet of Things Cyber Physical Systems
Industrial Internet Embedded Systems
Industry 4.0
Smart Factory
Result
Technical requirementInfrastructure requirement
Types of Integration in Industry 4.0
Integration of different IT systems on different hierarchy levels (e.g. actors and sensors level,
control level, manufacturing management level, manufacturing execution level, corporate planning
level) to a consistent solution. [AKI 2013]
Vertical Integration
Integration of different IT systems for different process steps of manufacturing and corporate
planning which are connected through material, energy, or information flows both company-wide (e.g. inbound logistics, manufacturing, outbound logistics) and across several companies to get a
consistent solution. [AKI 2013]
Horizontal Integration
company-wide
planning layers company-wide and cross-company
value chains
CT Transformation
In-Memory Big Data
MobilityCloud
Machine and device integration
Manufacturing execution layer
Systems integration
Enterprise and planning layer
TRANSFORM
Analytics
Challenges in Industry 4.0OrganizationManaging complex systems and locations
Legal Framework
Work Organization and Design• Creating new jobs in hybrid
industries
Human Training
Socio-Technical System
Standards• ISO and others SDOs• Reference materials• SCB
Technology• Real Time analytics• Embedded sensors• Comprehensive broadband
infrastructure• Security
NAS 2017:Areas of Continuous Discussion & Challenge*
• CQA’s (Critical Quality Attributes), QbD (Quality by Design) and CPP’s (Critical Process Parameters)
• Manufacturing and analytical technologies: in-process and rapid release
• Manufacturing models
• Comparability for regenerative cellular products
• Regulatory landscape and standards needs
StandardsEstablishment
SDOs develop, publish, and update
standards
SCB coordinates standards /
related items upstream and
downstream of SDOs
NIST and other federal laboratory programs
support standards development
Users ensure standards relevance
Public and private sector
entities contribute
expertise to standards
development
Synergizing Efforts For Standards Development
Global Standards development and establishment coordinated through the SCB is a multi-networked initiative with numerous public and private stakeholders across sectors
Progress in Standardization- SCB ISO US TAG 276
• Ancillary materials 3 parts: General, Suppliers and Users– Traceability– Safety
• Bioprocessing: upcoming white paper on areas to be addressed that are not considered under current guidelines– Single use considerations– IT infrastructure to support it
• Transportation and logistics– Location and temperature controls– Other cell safety/yield considerations: pressure, movement and others – Risk assessment: chain control
Progress in Standardization- SCB ISO US TAG
• Ancillary materials 3 parts: General, Suppliers and Users– Traceability– Safety
• Bioprocessing: upcoming white paper on areas to be addressed that are not considered under current guidelines– Single use considerations– IT infrastructure to support it
• Transportation and logistics– Location and temperature controls– Other cell safety/yield considerations: pressure, movement and others – Risk assessment: chain control
AKRON BIOTECHClaudia Zylberberg, PhD. CEO
THANK YOU
Akron Biotech- Integration at work TM
Phone: 561-750-6120
Fax: 561-750-6140
Toll-Free Phone: 1-888-70Akron (25766)
Toll-Free Fax: 1-888-60Akron (25766)
Website: www.akronbiotech.com
Email: [email protected]
Sales Department: [email protected]
Technical Support: [email protected]
Customer Service: [email protected]
