Phase I to II

Having demonstrated safety on a limited number of patients, your focus is now on efficacy. Many more patients are being dosed at multiple centers, while investigators are urgently addressing process, analytical and logistics challenges to meet demand and satisfy increased quality and regulatory requirements.

How does iVexSol solve batch-to-batch comparability issues?

Monocolonal Process

Traditional vector manufacturing results in a new batch of packaging cells with every run. Polyclonal processes like these are difficult to control and have wide fluctuations in yield and quality even within a given scale.

Using your vector backbone and accessory genes, iVexSol will create a project-specific, clinical-grade master cell bank of producer cells engineered to generate optimized vector for your unique process. This bank of monoclonal producer cells will create a final vector preparation of predictable quality with minimal batch-to-batch variability. This will minimize your CMC burden and greatly reduce your need for comparability studies saving you time and money.

How does iVexSol solve the need for securing additional production slots?

Vector On Demand

Clinical Lentiviral vector manufacturing campaigns often take 12-18 months to secure and execute. Programs at this stage of development are often attempting to increase their production scale, requiring new rounds of process development. These large-scale development runs are costly in terms of time and money, frequently resulting in stalled programs and missed milestones.

Our ability to generate master cell banks of stable vector-producing cells transforms production by enabling “vector on demand”. Rather than restarting a highly variable and risky process from scratch each time you need more vector, we simply expand a vial from your bank, harvest and cryopreserve the precise amount of vector you require, and ship it to you (or anywhere else in the world) ready to use within weeks, not months, of your order.

How does iVexSol solve skyrocketing production costs and changes in product potency?

Ultra Batch

As vector production volumes increase, so does cost of goods, capital costs, overhead, and batch failure rates. Increasing scale and aligning manufacturing with increasing quality demands such as removing serum or changing from adherent to suspension production commonly results in altered product potency. This variability increases CMC and analytical filing demands. Resulting in a significant amount of the batch being used to support QA/QC regulatory testing requirements rather than the manufacture of patient doses. This, in turn, requires the production of yet more batches to ensure supply and yet more CMC burden to prove comparability.

iVexSol’s uses an optimized monoclonal master cell bank to initiate every production run which can be expanded to any scale without changes in product quality. As opposed to traditional manufacturing, iVexSol’s Intelligent Manufacturing allows for rapid progression from small to ultra-scale batches which allow you to treat more patients with the same batch reducing clinical variability, CMC burden, and timeline delays.

Traditional vector manufacturing results in a new batch of packaging cells with every run. Polyclonal processes like these are difficult to control and have wide fluctuations in yield and quality even within a given scale.

Using your vector backbone and accessory genes, iVexSol will create a project-specific, clinical-grade master cell bank of producer cells engineered to generate optimized vector for your unique process. This bank of monoclonal producer cells will create a final vector preparation of predictable quality with minimal batch-to-batch variability. This will minimize your CMC burden and greatly reduce your need for comparability studies saving you time and money.

Clinical Lentiviral vector manufacturing campaigns often take 12-18 months to secure and execute. Programs at this stage of development are often attempting to increase their production scale, requiring new rounds of process development. These large-scale development runs are costly in terms of time and money, frequently resulting in stalled programs and missed milestones.

Our ability to generate master cell banks of stable vector-producing cells transforms production by enabling “vector on demand”. Rather than restarting a highly variable and risky process from scratch each time you need more vector, we simply expand a vial from your bank, harvest and cryopreserve the precise amount of vector you require, and ship it to you (or anywhere else in the world) ready to use within weeks, not months, of your order.

As vector production volumes increase, so does cost of goods, capital costs, overhead, and batch failure rates. Increasing scale and aligning manufacturing with increasing quality demands such as removing serum or changing from adherent to suspension production commonly results in altered product potency. This variability increases CMC and analytical filing demands. Resulting in a significant amount of the batch being used to support QA/QC regulatory testing requirements rather than the manufacture of patient doses. This, in turn, requires the production of yet more batches to ensure supply and yet more CMC burden to prove comparability.

iVexSol’s uses an optimized monoclonal master cell bank to initiate every production run which can be expanded to any scale without changes in product quality. As opposed to traditional manufacturing, iVexSol’s Intelligent Manufacturing allows for rapid progression from small to ultra-scale batches which allow you to treat more patients with the same batch reducing clinical variability, CMC burden, and timeline delays.


Meet iVexSol’s Intelligent ManufacturingTM

How does it work?

iVexSol’s next-generation stable lentiviral vector production platform begins with the generation of a clonally-derived master cell bank of stable vector-producing cells for the production of your gene of interest.

3

Transduction

Serum-free, suspension host cells are transduced with uL quantities of plasmids.

2

Plasmid Engineering

Plasmids are linearized and re-engineered to include inducible constructs.

1

Vector Fitness Testing

We begin by fitness testing your current platform to ensure it is fit for purpose.

Group 722 Group 723 Group 724 Group 725 Path 1370 Group 726 Group 727
4

Selection

Cells are seeded, expanded, and screened in to identify highly productive clones.

5

Optimal Producer

Optimal producers are further screened for stability, functionality and safety.

6

MCB Generation

Optimal clones are expanded to create a Master Cell Bank.

7

Long Term Storage

MCB is cryopreserved and split 50/50 for off-site storage.

1

Vector Fitness Testing

We begin by fitness testing your current platform to ensure it is fit for purpose.

2

Plasmid Engineering

Plasmids are linearized and re-engineered to include inducible constructs.

3

Transduction

Serum-free, suspension host cells are transduced with uL quantities of plasmids.

4

Selection

Cells are seeded, expanded, and screened in to identify highly productive clones.

5

Optimal Producer

Optimal producers are further screened for stability, functionality and safety.

6

MCB Generation

Optimal clones are expanded to create a Master Cell Bank.

7

Long Term Storage

MCB is cryopreserved and split 50/50 for off-site storage.

Then, whether it be your initial production run or a subsequent run, each time you need more vector, we simply expand a vial from your bank, harvest and cryopreserve the precise amount of vector you require and then send it to you (or anywhere else in the world). On demand: All within weeks, not months of your order.

brand icon

Vector “On Demand”

 


A quantum leap for cell and gene therapy…

iVexSol’s Intelligent ManufacturingTM uses technology that solves many of the challenges facing next generation cell and gene therapy developers

Reduced CMC and
Analytical Demands
Reduced Comparability
& Release Testing
Simplified Trial Design
& Interpretation
Increased
Safety Profile
Reduced Supply
Chain Risk
Reduced Inventory
and Wait-Times

Please click the options to see how iVexSol solves the challenges

optimal_producer

Generating vector from a uniform population of cells (in your bank) significantly reduces batch to batch variations, which minimizes variations in transduction, reducing both CMC and analytical testing.

Group 613-1

Generation of ultra-scale batches precludes the need to repeatedly perform comparability studies on multiple batches of vector, preserving vector and reducing regulatory burden and complexity.

graph_icon-1

employing a single (ultra-scale) batch that virtually eliminates batch to batch variation minimizes the number of replicates needed, greatly simplifying clinical trial design and interpretation.

clip_board-01-1

Generating vector from a thawed vial (from your bank) precludes the need for plasmids or transduction-improving reagents, greatly increasing the safety profile as compared to transient systems.

Group 615-1

The ability to rapidly produce ultra-scale batches of vector from banks that are securely stored at multiple locations minimizes supply chain risk.

Group 611-1

The ability to generating vector “on-demand” from a thawed vial (from your bank) in weeks rather than 9-12 months minimizes the need for companies to produce (and secure) large inventories of vector before they are needed.

Reduced CMC and
Analytical Demands
optimal_producer

Generating vector from a uniform population of cells (in your bank) significantly reduces batch to batch variations, which minimizes variations in transduction, reducing both CMC and analytical testing.

Reduced Comparability
& Release Testing
Group 613-1

Generation of ultra-scale batches precludes the need to repeatedly perform comparability studies on multiple batches of vector, preserving vector and reducing regulatory burden and complexity.

Simplified Trial Design
& Interpretation
graph_icon-1

employing a single (ultra-scale) batch that virtually eliminates batch to batch variation minimizes the number of replicates needed, greatly simplifying clinical trial design and interpretation.

Increased
Safety Profile
clip_board-01-1

Generating vector from a thawed vial (from your bank) precludes the need for plasmids or transduction-improving reagents, greatly increasing the safety profile as compared to transient systems.

Reduced Supply
Chain Risk
Group 615-1

The ability to rapidly produce ultra-scale batches of vector from banks that are securely stored at multiple locations minimizes supply chain risk.

Reduced Inventory
and Wait-Times
Group 611-1

The ability to generating vector “on-demand” from a thawed vial (from your bank) in weeks rather than 9-12 months minimizes the need for companies to produce (and secure) large inventories of vector before they are needed.

iVexSol Vector Graphic - gray-01
Any Lenti
Mask Group 23
Any Scale
iVexSol Vector Graphic - gray-01
Mask Group 1

Want more information?

Or let us know where you are in your clinical development to learn more about how our solutions can help you now.

HOW CAN WE HELP?

CONTACT US TODAY.