Xvivo System model X2

CYTOCENTRIC MODULAR CLOSED ASEPTIC CONTAINMENT ISOLATOR

The 21st Century GMP Quality Platform for processing and producing clinical grade cells.

Flexible Facility for the Future

 

•  Cell production facility cost reductions of 90%

•  Respond to any demand just-in-time, eliminating risky long-term bets

AGNOSTIC TO PRODUCTION PROCESS

 

Quality recognizes that no cell production process should be excluded. Extreme modularity and a large and growing library of general and specialized modules should quickly configure to fit any production process. The Platform does this now.

PROCESS CHANGE  

 

Quality recognizes that reconfiguring as the process changes should be simple and easy, with 0% variance risk and evidence to prove it. The Platform does this now.

AUTOMATION

 

Quality recognizes that migration from manual production processes to automated needs to be seamless with every automation option (off-the-shelf, bespoke, man-mimetic robotic arms), and every path to automation needs to be wide open to every different development strategy. All the typical negative side effects of the automated machines need to be neutralized, and all the automation needs to operate aseptically in a cell optimized environment. The Platform does this now.

AUTOMATING WITH MAN-MIMETIC INDUSTRIAL ARMS

1. MANUAL PRODUCTION PROCESS

Rate limiting step 1.

2. MAN-MIMETIC SEMI-AUTOMATED PROCESS

No change in process from manual to semi-automated.

 

3. MAN-MIMETIC SEMI-AUTOMATED PROCESS

Rate limiting step 2.

 

4. MAN-MIMETIC FULLY AUTOMATED PROCESS

No change in process from manual to automated

.

 

AUTOMATING WITH OFF-THE-SHELF & BESPOKE ROBOTS

1. MANUAL PRODUCTION PROCESS

 

2. BUILD NEW ROBOTIC SUBASSEMBLY

 

3. SPLIT WHERE NEW ROBOTICS WILL GO

 

4. SPLICE IN NEW AUTOMATION MODULE SET

 

5. RE-ASSEMBLE WITH NEW ROBOTIC SUBASSEMBLY

 

6. ISOLATED AUTOMATED PRODUCTION

 

SYNERGIZE ALL MODES OF AUTOMATION

SCALE-UP 

 

Quality recognizes that scale up must be efficient (precisely proportionate, fast, and elastic) with 0% variance risk and evidence to prove it, and just-in- time on demand to eliminate risky long-term projections and commitments. The Platform does this now.

SCALE-UP FAST

 

SCALING CULTURES & BIOREACTOR TOO BIG TO ASEPTICALLY TRANSPORT

PROCESS CHAMBERS AS INCUBATION CHAMBERS

 

Corning Hyperstacks incubating in process chamber.

Roller Bottles incubating in process chamber.

GE FlexFactory Cell Production

Scale each step as it becomes rate limiting. 

 

MULTIPLE DOCKING OPTIONS FOR ASEPTIC TRANSFER OF LIQUID OR MATERIAL FROM ONE ISOLATOR TO ANOTHER

 

SCALING THE PRODIGY WITH 3RD PARTY CULTURE VESSELS

 

SCALE-UP: Massively Parallel Large Batch

 

Quality recognizes that unlimited batches must be producible simultaneously side-by-side (massively parallel) with 0% cross contamination risk and 0% variance risk and evidence to prove it. The Platform does this now.

SCALE-UP: Large Batch

 

Quality recognizes the need to integrate with external large scale production equipment in order to close and cell optimize the critical upstream inoculums seed train. The Platform does this now.

SCALE-OUT: Different Processes

 

Quality recognizes that scaling out of different production processes must be efficient (precisely proportionate, fast, and elastic) and not dependent on risky long term predictions (just-in-time on demand) with 0% variance risk and evidence to prove it. The Platform does this now.

 

4 Different Production Processes

 

SCALE-OUT: Distributed Manufacturing of Same Process

 

Quality recognizes that scale out of unlimited numbers of identical batches must be producible widely dispersed globally with 0% variance risk and evidence to prove it. The Platform does this now.

Replication/Reproduction — Cloneable Conditions

Toronto

 

Replication/Reproduction — Cloneable Conditions

San Diego

 

Replication/Reproduction — Cloneable Conditions

London

 

Remote Access: monitor all from one location!

1X Scale

 

2X National Scale-out

 

4X National Scale-out

 

8X International Scale-out

 

TRACKING QUALITY OF EVERY BATCH GLOBALLY…

with evidence to prove it.

 

GLOBAL PREVENTIVE MAINTENANCE AND TECH SUPPORT…

with evidence to prove it.

 

MOBILITY

 

Quality recognizes that production capacity must be quick and easy to move, to different locations globally, nationally, locally as needed, within weeks, with re- validation guaranteed. The Platform does this now.

Former Location: Biotech incubator/office space for Pre-IND/Phase 1 trials

Current Location: New company headquarters for Phase 2 scale up

ECOFRIENDLY & COST EFFECTIVE

 

Quality recognizes that cost efficiency and low-carbon footprint are fundamental quality attributes, critical for commercial viability and sustainability. Drastically reducing carbon footprint of facility lifecycle, compared to conventional brick-and-mortar legacy GMP facilities, reduces production facility costs by 90%. Closing processes dramatically alleviates need for expensive, high-carbon footprint cleanroom quantity and quality, and allows smaller facilities that operate more efficiently by an order of magnitude. The Platform does this now.

AT EQUIVALENT PRODUCTION CAPACITY, LEGACY GMP CLEANROOMS COST 10X MORE

CYTOCENTRIC ISOLATOR OPERATING COSTS ARE EXTREMELY LOW

HVAC

Low Carbon Footprint

CLEANING

Low Carbon Footprint

GARB

Low Carbon Footprint

LEGACY GMP CLEANROOM OPERATING COSTS ARE STAGGERING

HVAC

High Carbon Footprint

CLEANING

High Carbon Footprint

GARB

High Carbon Footprint

The move to Cytocentric Isolators reduced costs, processing times and risk to the product as well as provides a safer and more comfortable environment for operators.”

– Victorian Consortium for Cell-based Therapies (VCCT)

CLOSING PROCESSES DECREASES FACILITY COST

Closing decreases classification and square footage requirement for cleanrooms, without affecting production capacity.