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Cognate Bioservices Manufacturing process V5

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Transcript of Cognate Bioservices Manufacturing process V5

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
LIMS, QMS, ERP, MRP, DMS, Billing, Bar Coding, Advanced Labeling

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 pieces are available and what is custom?

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 Stem 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 12-year operating history with no FDA 483s in its operating history
Most recent FDA audit occurred in January, 2015
Robert E. Margolin
Vice President, Corporate Development
13 years of cell therapy manufacturing expertise

Robust commercial scale infrastructure

Strong Phase III experience

Strategically centralized cGMP facility

Systems tailored to blood derived cell therapy products
KEY HIGHLIGHTS
OPERATIONAL HEADQUARTERS
Bethesda, MD
cGMP MANUFACTURING FACILITY
Isreal
PROCESS DEV & SCALE-UP
Hanover, MD
cGMP MANUFACTURING FACILITY
Memphis, TN
cGMP MANUFACTURING FACILITY
Germany
cGMP MANUFACTURING FACILITY
UK
PROCESS DEVELOPMENT


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

Scaffold & Biomaterials
Synthetic Biologic
October 30, 2015 – (Reuters) –

“Novartis plans to seek U.S. approval next year for CTL019 in children with acute lymphoblastic leukemia (ALL) - a cancer caused by uncontrolled proliferation of immature white blood cells that can cause death within a year of its diagnosis.

About 6,000 Americans annually are diagnosed with ALL
,

about 60 percent of them under age 20. In 2017, Novartis will aim for a far bigger market: patients with the most common form of non-Hodgkins lymphoma, called diffuse large B-cell lymphoma (DLBCL).

An estimated 25,000 new U.S. cases of the aggressive blood cancer
, and 10,000 deaths from it, are seen each year.
Novartis, Juno face production hurdles for new blood cancer drugs
SCHEDULING
LEUKAPHERESIS
MANUFACTURING
QC/QA, STORAGE, LOGISTICS
CLINIC/PHARMACY
BED-SIDE
TRANSPORTATION
Packaging and Shipping of Leukapheresis Cont.
Leukapheresis Procedure and Logistics
“Cant make silk out of a sow’s ear…”
Sponsor’s responsibility to assess/vet each collection center. Put agreements in place with all the 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
Develop packaging, instructions and support kits
Determine equipment acceptance criteria (3 major machines) Gas permeable bags?
Determine maintenance and calibration requirements
Assess center’s apheresis techniques and processes
Develop SOPs/parameters/collection process requirements (approved by Sponsor)
Provide training to collection center
Equipment focused development studies


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?

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?
What did Dendreon do?
Dendreon jump start

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

How to track 100s or even thousands of inbound product?
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?

We trust our couriers, however, over a decade of work is established. 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??


MATERIALS
Cold Chain
FDA has made it clear that any courier that turns over to airlines the courier looses control until its handed back at the other end.
Then we also have an understanding of the airlines that the couriers are using
Lots of involvement with the courier to understand flight patterns
Courrier even understands when to drive the flight to a nearby airport (7%)
This all needs to be understood between all parties involved. Everyone needs to be informed.
FedEx/UPS of have president of logistics. Probably not a bad idea. Most of the time this gets handed off to materials and clinical operations

A look at the our sponsors


Needs to be within timeframe
Stays in shipper until end of use date.
Policy in place for transfer
Transfer for further cryo transfer for patient infusion
Washing and Dilution and Recounting.
Guidance docs/forms to complete/timeline
Development data supports all of this
Needs to go in within 30 minutes
Cold Chain – Pharmacy
Complete, Customized and Fully Integrated Cell Therapy Manufacturing and Strategic Sourcing Solutions for Clinical and Commercial Scale CAR-T Technologies
Full transcript