Case Studies

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.

Watch these webinars for more information:

• Single-Pass Tangential Flow Filtration: A Critical Operation Within the Continuous Bioprocess
• High Viscosity Ultrafiltration Formulation for Plasma IgG and mAbs
• Application of QbD Principles to Ultrafiltration Operations in Bioprocessing

Learn more about Single-Pass TFF technology:

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.

Watch these webinars for more information:

• Ion Exchange Chromatography for Protein Production Part 1
• Ion Exchange Chromatography for Protein Production Part 2

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.

Watch these webinars for more information:

• Designing an Economic and Efficient Buffer Operation
• Overcoming Quality and Regulatory Challenges of Implementing Single-Use Pharmaceutical Manufacturing

Read this application note about sizing methods:

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.

Watch this webinar for more information:

• Process Development Best Practices: Optimizing Normal Flow Membrane Filters Operated in Series

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.

Watch these webinars for more information:

• Quality by Design Principles in Aseptic Processing: Have you minimized your sterile filtration risk?
• Sterile Filtration Validation Best Practices