Phase I

Early stage clients have completed their preclinical studies, are anticipating IND approval and gearing up to start Phase I clinical studies. We can support you through this stage by providing Intelligent SolutionsTM to challenges such as:

How do you meet clinical-grade lentiviral vector production standards while also securing supply?

Complete Lifecycle Support

Producing vector to support your preclinical and early-stage programs is not the issue, the issue is securing enough vector of sufficient quality while concurrently competing for scarce manufacturing slots.

iVexSol’s Intelligent Manufacturing provides complete lifecycle support by using a process compatible with all stages of clinical development from pre-IND to post-commercial, assuring that you always have vector at the quality you need, when you need it, and without resorting to over-buying to secure your supply.

How do you align your pre-clinical process and data with your GMP process and data?

Monoclonal Process

Preclinical manufacturing methods are not appropriate for clinical use. The necessary changes in quality and (production) scale often alters both process and product behavior, leading to new rounds of process development and prolonged comparability studies that can threaten to derail early programs.

iVexSol’s Intelligent Manufacturing uses a monoclonal process capable of generating raw material that can be faithfully reproduced batch-to-batch and is easily amenable to scale up, eliminating these costly delays.

How do you ensure your lentiviral vector is fit for purpose?

Vector Fitness Testing

If your vector is capable of high-titer production at lab scale, then iVexSol’s Intelligent Manufacturing will preserve and likely improve those titers. This is often however, not the case, and even at small scale, challenges such as splice variation, codon usage, and non-optimized promoter and backbone choices can rob your vector of titer and clinical efficacy.

iVexSol performs Vector Fitness Testing as part of our Intelligent Manufacturing to assure that you are delivering the best possible construct to your process.

Producing vector to support your preclinical and early-stage programs is not the issue, the issue is securing enough vector of sufficient quality while concurrently competing for scarce manufacturing slots.

iVexSol’s Intelligent Manufacturing provides complete lifecycle support by using a process compatible with all stages of clinical development from pre-IND to post-commercial, assuring that you always have vector at the quality you need, when you need it, and without resorting to over-buying to secure your supply.

Preclinical manufacturing methods are not appropriate for clinical use. The necessary changes in quality and (production) scale often alters both process and product behavior, leading to new rounds of process development and prolonged comparability studies that can threaten to derail early programs.

iVexSol’s Intelligent Manufacturing uses a monoclonal process capable of generating raw material that can be faithfully reproduced batch-to-batch and is easily amenable to scale up, eliminating these costly delays.

If your vector is capable of high-titer production at lab scale, then iVexSol’s Intelligent Manufacturing will preserve and likely improve those titers. This is often however, not the case, and even at small scale, challenges such as splice variation, codon usage, and non-optimized promoter and backbone choices can rob your vector of titer and clinical efficacy.

iVexSol performs Vector Fitness Testing as part of our Intelligent Manufacturing to assure that you are delivering the best possible construct to your process.


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.

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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.