Case Studies

 
 
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You might be faced with numerous challenges during blood plasma processing. Rest assured we have a dedicated team of experts with the experience and capabilities you need to help with reducing time to market, improving process economics and increasing productivity, as well as managing risk.

Our global network of regulatory, quality and technical experts, combined with our process and analytical capabilities, can provide a flexible and customized solution for you. We will power through every challenge that faces you.

Read the following examples of customer collaborations to envision how we can help you reach your goals today.

Speed to Market  | Process Economics & Productivity | Risk Management

Speed to Market


Customer Challenges
How can I isolate and purify a molecule from my existing feed stream without damaging it?
We’d like to isolate additional molecules from our existing feed stream. We’ve been unsuccessful in designing a process that would achieve the correct concentration without damaging the molecules or requiring additional capital for our equipment. How can we minimize the shear stress caused by multiple pump passes and decrease process volume prior to the chromatography step?

Our Solution:

We recommended that the customer use Single-Pass Tangential Flow Filtration (TFF) for this process, as we believed it would meet their high concentration goals, while minimizing stress placed on the molecules. We ran bench-scale trials to determine the proper membrane, number of sections, processing conditions and membrane area. This was followed by a pilot scale run to confirm process conditions and make larger quantities of materials for process validation. The trials identified Pellicon® 3 Cassettes with Biomax® Membrane as the best option for recovery and purity of the customer’s molecules.

Customer Outcome:

The customer ultimately selected our Single-Pass TFF option including Pellicon® 3 cassettes with Biomax® 50 membrane due to its simplicity and effective performance, as well as successful scale-up capabilities. Additionally, they appreciated the ongoing on-site and off-site support available to them throughout the evaluation and implementation process. A successful outcome was possible thanks to the approach and capabilities of Single-Pass TFF which helped to reduce process volume, eliminating the need for additional capital investment for their chromatography step.
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Learn more about Single-Pass TFF technology:

How can I optimize a new chromatography process efficiently and quickly?
We’re developing the chromatography step for a new process and our flow rates and purity levels are much lower than our targets. We’re under pressure to get this process validated quickly but we have limited resources to make the necessary improvements. How can we optimize this chromatography step efficiently and quickly?

Our Solution:

For this application, we performed a series of on-site chromatography trials with systematic parameters that we developed for the customer using a selection of our Fractogel® resins. For process development screening, we evaluated the purity and yield of the therapeutic after two chromatography steps. We identified Fractogel® TMAE and Fractogel® DEAE resins as the most suitable options for their process.

Customer Outcome:

Fractogel® TMAE and DEAE resins along with QuikScale columns were selected by the customer as they provided a solution to decrease processing time, while increasing purity and yield in comparison to the competitive resin they had been using. 
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Process Economics & Productivity


Customer Challenges
How can I minimize stainless steel tanks in buffer preparation?
How can we minimize the use of stainless steel tanks and reduce the buffer batch preparation required for each lot of our plasma product?

Our Solution:

Due to the broad need for buffer solutions throughout a plasma manufacturing process, buffer filtration is typically a high volume operation. Thus, efficient sterile filtration of buffer solutions is critical to ensure a successful and timely batch operation. Our dedicated team of experts started the project by running Vmax™ studies on the customer’s buffers, in triplicate. The Vmax™ method is commonly used in a variety of applications to estimate filter size requirements for normal flow membrane filters. Based on the study results and superior performance in similar applications, we recommended Millipore Express® PHF filters attached to 10, 20, 50, 100, 200, and 1000 L single-use bag assemblies. These assemblies included Mobius® 2D bags and Lynx® S2S connectors. To allow for one filter to fill several bags, filters were not built into the assembly.

Customer Outcome:

Once these new assemblies were implemented, the customer was able to make larger batches of buffers that could be used over multiple lots of product, increasing process efficiency and decreasing time and cost associated with cleaning of tanks and intensive buffer preparation. The consistent communication from our on-site team continues to provide the customer with simple order tracking and assurance that everything will arrive on time.
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Read this application note about sizing methods:

How can I better harmonize my prefiltration process?
We use a variety of filters and a range of suppliers for our chromatography column protection needs. How can we effectively harmonize these processes across multiple manufacturing facilities and decrease our cost?

Our Solution:

To achieve a more streamlined process, we recommended that the client investigate the savings possibilities in their prefiltration steps. We performed scale-down trials to demonstrate that one Opticap® XLT 30-inch filters with Polygard® CN media could provide the same level of performance as two of the competitive filters currently in use for their prefiltration steps.

Customer Outcome:

With our help and the robust performance of our Polygard® CN filters, our clients realized the cost benefits of process compaction and successfully harmonized the processes of multiple facilities with the added benefits of cost savings. Additionally, since Polygard® CN filters are standard, in-stock items in our catalogue, the customer was assured of increased security of supply.
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Risk Management


Customer Challenges
How can I prevent contamination at the final fill step?
We’re concerned about contamination risks at the final fill step and need to convert to a single-use process. However, the filters we’ve evaluated are absorbing our plasma product and decreasing our yields.

Our Solution:

For this application, we recommended the customer evaluate our single-use redundant filtration assembly. Our Manufacturing Sciences and Technology (MSAT) engineer evaluated filter performance after the customer’s stabilizing treatment and heating processes. For prefiltration, we recommended Polysep® filters because they decreased the necessary sterile filtration area, providing cost benefits to the customer. We also recommended Durapore® filters because they have historically proven to not decrease yield in similar processes. Additionally, we provided extensive training and technical support to ensure operators were equipped with the knowledge to run these processes.

Customer Outcome:

The customer selected Polysep® 1-0.5 and Durapore® 0.22 filters for use after stabilizer treatment and heating processes. By assembling these filters into a single-use redundant filtration format, the result was decreased contamination risk, improved process economics and improved product yield.
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