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Cognate Bioservices WSCS - v9 9.12.16

9.12.16

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Transcript of Cognate Bioservices WSCS - v9 9.12.16

SCHED. DATA
Scheduling System and Staff
Scheduling System and Staff
Scheduling System and Staff
Scheduling System and Staff
Scheduling System and Staff
Tracking System
Tracking System
Tracking System
Tracking System
Cold Chain Logistics
Cold Chain Logistics
Cold Chain Logistics
Training and Standardization
Training and Standardization
Training and Standardization
Training and Standardization
200 plus sites
Standardization and Training
AUTOLOGOUS CAR-T MANUFACTURING PROCESS
What is the balance between logistics and biology?

How does this redefine our priorities?

What systems are needed and when?

What systems are available and what are custom built?

How can your CMO help put the pieces together?

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AUTOLOGOUS CAR-T MANUFACTURING PROCESS
OUR LOCATIONS
OUR SERVICES & CORE CAPABILITIES
OUR EXPERTISE: CELL-BASED PRODUCTS

Immune Cells
Dendritic Cells
T Cells/NK Cells
Primary Cells
Chondrocytes
Epithelial cells
Fibroblasts
Mesenchymal Stem Cells
Adipose, Bone Marrow
Cord Blood
Other Stem Cell Types
Hepatic Stem Cells
Hematopoietic Stem Cells
Gene Modified
Tissue & Blood Processing, Storage and Logistics
OUR EXPERIENCE: AUTOLOGOUS PHASE III

LATE-STAGE TRIAL EXPERIENCE
Supporting the largest international Phase III autologous cell-based immunotherapy trial
Clinical trial consists of over 300 patients and 88 active clinical sites
Extensive experience in handling/scheduling freshly harvested and time sensitive leukapheresis
Robust systems for supporting end-to-end logistics and quality

QUALITY ASSURANCE (QA) /QUALITY CONTROL (QC)
In-house QC testing
Best-in-class Quality Management System

STRONG OPERATING HISTORY AND TRACK RECORD
Successful 13-year operating history with no FDA 483s in its operating history
Most recent FDA audit occurred in January, 2015
13 years of cell therapy manufacturing expertise

Robust commercial scale infrastructure

Strong Phase III experience

Strategically centralized 80,000 sq. ft. cGMP facility

Systems tailored to autologous cell-based immunotherapy products
KEY HIGHLIGHTS
cGMP MANUFACTURING
Isreal
PROCESS DEV & SCALE-UP
Hanover, MD
cGMP MANUFACTURING FACILITY
Memphis, TN
cGMP MANUFACTURING
Germany
GMP Manufacturing Facility
Cambridgeshire, UK
PROCESS DEVELOPMENT


cGMP MANUFACTURING
SCALE-UP/ VALIDATION
ADDITIONAL SERVICES
Technology Transfer
Assay Development
Process Optimization
Safety Studies
Cell Characterization
Clinical Operations
Cell Banking
Cell Manufacturing
Process Automation
Quality Assurance
Validation
Control Testing
Storage & Distribution
CMC/IMPD Support
Finish & Fill
Logistics/Tracking

Scaffold Biologics
Synthetic Biologic
SCHEDULING
LEUKAPHERESIS
MANUFACTURING
QC/QA, STORAGE, LOGISTICS
CLINIC/PHARMACY
BED-SIDE
Packaging and Shipping of Leukapheresis Cont.
Leukapheresis Procedure and Logistics


Sponsor’s responsibility to assess/vet each collection center. Establish agreements with all centers
Sponsor’s responsibility to provide clear and concise apheresis technique requirements
Many companies request support from Cognate’s Clinical Operations Team to do the following:
Develop checklist and requirements
Assess center’s apheresis techniques and processes
Develop SOPs/parameters/collection process requirements (approved by Sponsor)
Develop packaging, instructions and support kits
Determine equipment acceptance criteria
Determine maintenance and calibration requirements
Provide training to collection center

No way to fully ensure that the collection centers/clinical sites are following the procedures.
How much of this does your company plan to do?
Perform stability studies to determine function & viability of leukapheresis material at client's request

How many patients can a single scheduling coordinator support at any point in time?
What kind of scheduling IT systems are needed?
How much of this process can be automated?
Is there anything off the shelf available?
How long will it take to develop, test and validate the IT System?
How much money will it require?
Scheduling

TRANSPORTATION
Packaging and Shipping of Leukapheresis

How does intended manipulation impact viability

How can packaging impact viability and decrease temperature swings

Record temperature throughout all extremes

Tracking devices
Transportation

Blood Centers located close to major airport hub(s):
Pro – more likely to have backup flights
Con – Package trafficking becomes more difficult

Blood Centers close to small/medium sized airport(s):
Pro – package trafficking less complicated
Con – Flights are not consistent over time

Blood Centers in small cities and several hours from major airports
Pro – package trafficking least complicated
Con – Several hours between pick up and flight
Con – Limited flight options
Transportation Cont.

Courier Communication with CMO is CRITICAL

Airlines are conglomerating – schedules change regularly. Need to understand how this impacts the program.

Most east bound flights from the west coast depart by 3:00pm. Wait until morning or piece flights together?

Courier relationships have been developed over the last decade.

Flight decision trees are in place across the US. Regardless, the courier will contact the CMO about change decisions 24/7.

How does all of this affect the next steps??


Robust development work to tightly define parameters
Visibility and Traceability
Shipper is often your storage
Specialized receiving areas and procedures
Provide guidance docs/forms to complete/timeline
Transfer for further cryo before infusion
Washing, dilution and patient infusion
What is that time window?
Cold Chain – Pharmacy
"You can’t make a silk purse out of sow’s ear…"
LIMS, QMS, MRP, DMS, EMS, eBMR, Scheduling, Bar Coding, Advanced Labeling

Thank you & Questions
Courier Tracking
Caller
Job No
BOL No
References No
Pieces
Insurance Value
Service Type
In Transit
Invoice No
Weight
Billed Weight
Customs Value
Commodity
Pick Up Ready Date/Time
Delivery Deadline Date/Time
Pick Up Address
Delivery Address
Flight/Delivery Information
Status History
Flight Info (US)
Flight 1 Airline
Flight 1 Flight Number
Flight 1 Origin
Flight 1 ETD
Flight 1 AWB
Flight 1 Destination
Flight 1 ETA
Flight 2 Airline
Flight 2 Flight Number
Flight 2 Origin
Flight 2 ETD
Flight 2 AWB
Flight 2 Destination
Flight 2 ETA
Status History (US)
New Shipment: Date; Time; Airport
Reviewed by Customer Service: Date; Time; Airport
Flight Information Available: Date; Time; Airport
Pick Up Dispatched Date: Date; Time; Airport
Estimated Pick Up: Date; Time; Airport
Pick Up Confirmed: Date; Time; Airport
Tendered to Airline: Date; Time; Airport
Flight Departed: Date; Time; Airport
Flight Arrived: Date; Time; Airport
Recovered for Transfer to Next Courier: Date; Time; Airport
Out for Delivery: Date; Time; Airport
Delivered: Date; Time; Airport
Ed Samuel

Director of Manufacturing and Technology Transfer
LOGISTICS, SYSTEMS AND INFRASTRUCTURE TO SUPPORT COMMERCIAL SCALE AUTOLOGOUS IMMUNOTHERAPY MANUFACTURING
PRESENTATION OVERVIEW
Introduction to Cognate BioServices
Experience, Services, Capabilities

Introduction to Cognate in the UK
Manufacturing Facility Overview and Philosophy

Autologous CAR-T Manufacturing in the US
Scheduling, Logistics, Manufacturing & Delivery

Questions

Sawston, Cambridgeshire
Acquired c.530 acres in 2014





7,900m2 GMP Manufacturing Facility

1,700m2 GMP Lab Space

325m2 PD

1,450m2 Future
Expansion Space
Sawston Vision Centre – ATMP Manufacturing Facility

Sawston, Cambridgeshire
22 Miles to London Stansted Airport

4 Miles from M11 Junction 9

55 Miles to Central London

4 Miles Wellcome Trust Sanger Institute

5 Miles Babraham Research Campus

5 Miles Biomedical Campus
(Astra Zeneca / Addenbrookes Hospital)

7 Miles Cambridge city centre

Sawston Vision Centre
Sawston Onsite Progress
Infrastructure –

Increase in Power Supply to Site and Secured Dual Feed Electricity
Planning –
Consent Secured for Change of Use To GMP Manufacturing Laboratory Facility in the Vision Centre
Planning –

Consent Secured for 31% Increase in Floor Space in Vision Centre from 6,000m2 to 7,900m2
Design –
Review and Discussions with MHRA
Design –
Mock-up B Lab to test air flow dynamics
and critical equipment
Construction –
Phase 1a of Vision Centre development complete and undergoing validation activities

Sawston Vision Centre –ATMP GMP Manufacturing Centre
Sawston Vision Centre –ATMP GMP Manufacturing Centre
Sawston Vision Centre –ATMP GMP Manufacturing CentrE
Sawston Vision Centre –ATMP GMP Manufacturing Centre
Sawston Vision Centre – GMP ATMP Manufacturing Centre
GMP Manufacture – Multiproduct facility
Client Hotel Suites – Q1 2017
Designed for manufacture for early phase trials
Self contained suites for each client
Independent AHU for each suite
Single pass air supply
Independent gas supplies
Suites serviced by Cognate staff
Capability for manufacture of gene modified cells, viral vector, somatic cell therapies and tissue engineered products
Grade B & C Labs, QC Labs, Store and Offices
Operated under Cognate manufacturing authorisation license
Continuous Environmental monitoring
Unidirectional flow for materials

Sawston Onsite Progress
Contract Manufacture – Q3/Q4 2017
Late phase trials and commercial supply
Single pass air supply in each Grade B Lab
Capacity for 2-line operation in B Labs
Closed system processing in large Grade D lab
Unidirectional flow – personnel, materials
Gene modified cells, somatic cell therapies and TEP
Grade B Labs, C Labs and D Labs

GMP Manufacture – Multiproduct facility
QA/QC & QP
Entire facility operates under one EQMS with secure storage of client documents – paperless system
Cost and time savings for biotech start-ups with ready-to-go:
Validated clean-rooms
Validated Environment Monitoring System
Training package
Services (maintenance, cleaning, waste, etc)
Technical Support including process and analytical development/validation
Assistance with dossiers
Final release by Cognate QPs with facility to incorporate client QP on license
QC testing for in-process and final release
In-house routine EM

Manufacture
Early and late stage clinical trial through to commercial supply
Client led ‘Hotel’ space with CMO support for QA/QC and materials management


Process Development
GMP mock-up labs for tech transfer and process optimisation


Quality Control
Analytical
Microbiological
Cell culture


Materials Management
Raw material storage - quarantine and released goods
Final Product storage – ultralow freezers & vLN2
Product Shipment to end user
Logistics – Management of starting materials
Full transcript