Why Invest in Multiple Systems When You Can Do It All with One?

Introducing AdaptX™ Multi-Purpose Filtration (MPF) Systems By N+1

Background:

Until now the biopharmaceutical industry has typically focused on designing singular purpose systems for individual unit operations. The result has led to biopharmaceutical manufacturers living with cleanrooms crammed full of equipment from multiple unique vendors and a highly populated asset management system.

For instance, it takes two to three unique pieces of equipment from different vendors to run a viral filtration unit operation immediately followed by a tangential flow filtration operation within a downstream manufacturing suite. Those highly specialized systems come with the added negative of locking the workflow into a single style or portfolio of filters for each unit operation. While beneficial for the supplier, this lack of open architecture can inhibit biopharmaceutical manufacturers from truly optimizing overall workflow efficiency. N+1, in its commitment to helping its customers design forward thinking, lower cost, and more robust manufacturing processes believes that there is a better way for an organization to allocate CAPEX and achieve both open architectural flexibility and manufacturing redundancy.

AdaptX™ MPF Systems By N+1

One Quality Focused System, 6 Out of the Box Unit Operations, Multiple Ways to Optimize Your Workflow

When approaching the N+1 AdaptX™ MPF Pilot Scale System several things become  immediately obvious, the first one being that it does not resemble  a poorly designed science project. Detail has gone into ensuring the equipment is easily cleanable and the location of operation points are ergonomically conscious. From the smartly placed shelves for easy use of priming pumps, or temporary placement of batch records, N+1’s engineers have left no element without purpose.  The second striking observation is that there is an abundance of functionality, flexibility, and features packed into its footprint of just 9 sq. ft.

All variations of the AdaptX™ MPF product line—Benchtop, Pilot, and Full Scale—come with six unique unit operations out of the box and are designed to be linearly scalable from one product size to the next. Each system comes ready to go with:

●        Asymmetric Dialysis

●        Co / Counter Current Flow Perfusion

●        Traditional Ultrafiltration / Diafiltration

●        Single Pass Tangential Flow Filtration

●        Viral Filtration with Inline Gold Particle Testing

●        Microfiltration

The unit operations are designed to be a mixture of both more classical and more forward-thinking manufacturing workflow choices. The AdaptX™ line offers a refined take on the traditional UF/DF, Viral Filtration, Single Pass TFF, and Microfiltration unit operations with the incorporation of Equilibar SDO,valves providing users with an expanded array of TMP control capabilities over currently available commercial systems.

Note: TMP control data SDO (dark blue) vs pinch valve (light blue) courtesy of Equilibar

Platforming on Levitronix pumps, the unit combines this expanded TMP control functionality with one of the lowest shear delivery pumping systems on the market to ensure minimal impact to product quality over all of its unit operations. These classical unit operations are further enhanced by the sheer availability of pumps on the system, allowing customers to easily incorporate manufacturing improvements such as inline dilution of the filtration buffers as a day one workflow platform feature with no additional modifications to the AdaptX™ system for deployment.

What sets the AdaptX™ line apart is it’s out of the box commitment to next generation workflow functionality. AdaptX™ is the first to offer out of the box Asymmetric Dialysis functionality to allow customers a next generation solution with substantial benefits over traditional UF/DF. The system also can be coupled to a bioreactor and is capable of out of the box Co-flow or Counter Current Flow Perfusion modes to offer improvements over traditional Perfusion setups.

AdaptX™ additionally is flat sheet or hollow fiber filter adaptable allowing N+1’s customers to choose the filter and filter utilization strategy that they wish to implement inside of their workflow.

“We wanted to provide the customer with an open architectural, linearly scalable, solution for both todays and tomorrow’s workflows. From our benchtop to full scale system this was accomplished at all levels, from the adaptability of the single use elements to the multifunctionality and workflow automation connectivity strategy” Nephi Jones N+1 CSO

Redundancy to Eliminate Risk:

What is additionally striking when looking at an AdaptX™ filtration system is that you are actually looking at two fully redundant mirror image sides within its 9 sq. ft. footprint. For N+1 this was a critical design choice to help promote better manufacturing robustness and assurance of final product supply for its customers. One side of the system does not impact the other in the event of a failure. Allowing for an in-system assurance that impact to one side of the system will not immediately result in complete loss of functionality and manufacturing impact.

“As an end user when a system is down it can cripple your organizations throughput, in the best case this means wheeling your product into another manufacturing suite and limping along, in the worst case this means dumping your current batch and trying to fix the broken system as quickly as possible and re-forecasting your supply. In all of our systems, we want to try and eliminate this scenario from happening.” Robert Hendrix Ojeda N+1 CEO

A System Built for Batch or Semi Continuous Processing You Choose:

By designing the system with a mirror image profile N+1 wanted to give our customers additional benefits which cannot be realized by current system designs. Users can operate each skid in series or in parallel allowing for additional production benefits when choosing to utilize both sides of the AdaptX™ system simultaneously.

On AdaptX™, an end user can execute manufacturing processes on a single system that are normally only accomplished today by multiple systems of different sizes or by multiple systems for multiple unit operations. The AdaptX™ mirror image sides, for example, can be connected in series to achieve higher concentration specifications or handle higher starting concentration batches for final UF/DF processes. In other examples the system can be run in parallel and be pooled downstream for a perfusion process or be used to run separate unit operations in a semi continuous process such as running Viral Filtration on one side of the system while running UF/DF on the other.

The AdaptX™ system additionally comes in both low- and high-pressure pump configurations and has the capability to upsize the pumps on either side of the system with an easy change out feature. This allows the AdaptX™ system additional optimization functionality for semicontinuous workflow optimization, where scaling up or down in the subsequent unit operation is required.

Ultimately when compared against traditional workflow competitors this means that the AdaptX™ Pilot Scale System accomplishes in 9 sq.ft. of cleanroom space and a single system what a competing workflow accomplishes in 21-45 sq.ft and 2-4 unique systems.

Modular Single Use Manifolds Drive both Ease of Installation, Cost Effectiveness, and Adaptability of Functionality

N+1’s AdaptX™ design set out to additionally change the customers ease of installation and utilization of the single use elements on its filtration systems. Instead of bulky, hard to install, hard to safely ship, all in one flow kits; N+1’s AdaptX™ System incorporates smartly designed modular single use manifolds.

This strategy allows N+1’s customers to fully optimize the cost of the single use materials for each use of the system by only consuming and using the functionality that they need. The AdaptX™ controls its functionality by allowing the customer to adjust the single use configuration on the retentate and permeate inlets and outlets by adjusting 4 modular blocks. These blocks contain a combination of control valves and sensors. By adjusting the single use tubing flow through these blocks the skid can be easily adjusted to an optimized configuration for all 6 of the AdaptX™ out of the box unit operations.

“The modular single use elements were designed with operations in mind…. they are small, lightweight, easily installed, easy to train on, and ultimately adapt the skid’s functionality to the customer’s needs” Connor McCarthy EVP Commercial System Design

Multifunctionality of AdaptX™ Lowers Workflow CAPEX Allocation Necessary to Achieve Manufacturing Robustness

AdaptX™ multifunctional and modular design was purpose built to allow organizations to implement the system in multiple locations throughout the workflow and thus drastically reduce the needed capital necessary to achieve manufacturing redundancy. Purchasing two N+1 AdaptX™ systems provides equivalent redundancy to multiple separate systems. In a multi-unit operational scenario, this setup achieves n+1 redundancy for the series of unit operations and n+3 redundancy for each individual operation within the workflow. When compared to the current status quo a customer would need to purchase up to 6 competitor products across 2 to 3 vendors to achieve the equivalent level of manufacturing workflow redundancy offered by just 2 AdaptX™ skids.

“Our commitment is to ensure that our customers have the best available technology with the peace of mind that their manufacturing process will always be in a position to supply the treatments their patients rely upon. I think our strategy is definitely an improved design model for the CAPEX allocation necessary to achieve this desired level of manufacturing robustness” Nephi Jones CSO N+1

Summary

Within N+1 AdaptX™ space conscious design, the industry is now poised to benefit from new product features that offer customers a different, forward-thinking, and open solution for building out their process workflow. This system provides a streamlined pathway to next generation functionality with enhanced manufacturing redundancy. To learn more about the AdaptX™ product line and its open architectural features visit N+1 Process Engineering Solutions LLC .