Challenge:

We performed the initial phase of process development and hired a CRO for our pilot batch, however the results did not meet our expectations for scale up.

Solution:

The team performed studies in the M Lab™ Collaboration Center to select the proper filtration train and process adjustments. Clarification and UF/DF studies were carried out with two different lots of feed material to check variability before suggesting the final sizing.

Outcome:

The M Lab™ Collaboration Center team carried out additional studies together with the customer's team to ensure process optimization and smooth scale up.

Challenge:

Our downstream purification process for our Phase II mAb fusion protein had high aggregate and fragment levels with a very low yield. This process was inefficient and costly, and we struggled to find a solution.

Solution:

The team conducted a comprehensive downstream study in the M Lab™ Collaboration Center. The study included screening multiple chromatography resins, optimization of clarification, virus filtration and ultrafiltration operating conditions, and an analysis of extractables and leachables and product stability.

Outcome:

The team successfully optimized the customer's downstream purification process and incorporated multiple products into the process at 1,000-L scale.

Challenge:

We are a small novel therapies manufacturer with limited lab space and have specific technical questions around chromatography, clarification, and TFF.

Solution:

The team at the M Lab™ Collaboration Center met with the customer to answer their technical questions and demonstrated that our non-GMP lab space is a place where they can conduct tests that their own lab cannot accommodate.

Outcome:

The customer walked away from the visit feeling confident in the breadth and depth of our technologies and our commitment to helping emerging novel therapy manufacturers succeed.

Challenge:

We are a cell and gene therapy manufacturer looking to change out hollow fiber technology and replace it with microfiltration cassettes. How can we surmount hurdles in our existing process to make the switch?

Solution:

The tangential flow filtration experts at the M Lab™ Collaboration Center educated the customer on all aspects of TFF from the cassettes and hardware to best practices and implementation in their manufacturing process. The team shared ways to overcome process limitations through optimization techniques.

Outcome:

The customer walked away from the meeting feeling confident in our TFF expertise and agreed to set up local support with our process development scientists to evaluate Pellicon^® ultrafiltration cassettes.

Challenge:

The viscosity properties of our therapeutic at high concentrations slowed the overall performance of diafiltration/concentration significantly.

Solution:

The experts in the M Lab™ Collaboration Center performed Pellicon^® single-pass tangential flow filtration (SPTFF) trials with the customer after they had unsuccessful trials with our competitor. The customer was very surprised by how easy the Pellicon^® 3 Cassettes were to optimize and implement.

Outcome:

The customer achieved concentrations up to 240 g/L after implementing Pellicon^® single-pass TFF. They were so pleased with the results that they decided to implement SPTFF for all future clinical projects using our Pellicon® 3 cassettes.

Learn more about the BioContinuum™ Platform.

Challenge:

Clinical trial data indicated the customer needed to increase their drug production to accommodate a larger patient population, however their manufacturing process did not have the capacity to support more drug. A higher titer process would help, but downstream tank limitations posed a manufacturing bottleneck.

Solution:

The experts from the M Lab™ Collaboration Centers in Europe, the US and Singapore collaborated with the customer to implement Pellicon^® single-pass tangential flow filtration (SPTFF). The team identified where in the customer's process this technology could be placed and demonstrated its performance and feasibility to debottleneck the operation and fit within their existing facility.

Outcome:

In addition to the intensification of the customer's upstream process, the implementation of SPTFF in the downstream process yielded a 75% annual COGS reduction, and plant capacity required for molecule production decreased from 90% to 26%.

Learn more about the BioContinuum™ Platform.

Challenge:

Clinical trial data indicated the customer needed to increase their drug production to accommodate a larger patient population, however their manufacturing process did not have the capacity to support more drug. A higher titer process would help, but downstream tank limitations posed a manufacturing bottleneck.

Solution:

The team executed the first feasibility study using Pellicon^® single-pass tangential flow filtration (SPTFF). Next, the team performed experiments using Pellicon^® 3 cassettes with the client's product and executed an engineering run at scale in the M Lab™ Collaboration Center.

Outcome:

The use of Pellicon^® single-pass tangential flow filtration (SPTFF) will save the customer several millions of dollars per year due to the yield increase. The network of technical experts supporting the customer over the last five years was a huge contribution to this success and will set the stage for addressing challenges specific to plasma manufacturers.

Learn more about the BioContinuum™ Platform.

Challenge:

The customer observed premature pressure hold failures in their perfusion process and asked our team to conduct a study at the M Lab™ Collaboration Center to help them resolve this problem.

Solution:

An N-1 perfusion process simulation study was initiated at the M Lab™ Collaboration Center. This collaborative effort was designed to provide our current Best Engineering Practice (cBEP) recommendation for Prostak™ microfiltration modules that are exposed to multiple steam cycles, and to provide a formal data set that could be leveraged to support the customer's perfusion process using steam to achieve aseptic operating conditions.

Outcome:

The installation of spring washers reduced the magnitude of compressive forces that the Prostak™ microfiltration modules were exposed to during thermal cycles by a factor of 5-6x. The reduction in overall exposure is expected to prolong the life of these modules when used in a drug manufacturing process that includes steaming. The team was able to successfully produce data to support modification of the holder hardware, which would allow the customer to reliably achieve the specified target number of cycles with their modules.

Learn how to Lay the Groundwork for Downstream Success..

Challenge:

The customer recently acquired a new molecule and needed a strong partner who could provide advice on viral safety to ensure smooth production.

Solution:

The team of experts at the M Lab™ Collaboration Center left no questions unanswered during the customer visit. Post-visit, our scientists conducted trials using their product to give them complete confidence in our filters and concrete data to share with the FDA.

Outcome:

The customer was so pleased with the outcome of the trials that they adopted Viresolve^® Pro Solution. Their confidence in our viral safety expertise strengthened our partnership and led to further discussions on process optimization.

Visit our viral safety learning center for additional resources.

Challenge:

The customer was using Millipore Express^® SHF filters to sterilize a high pH cleaning solution containing detergent. They experienced periodic integrity test failures and were unable to determine the root cause.

Solution:

The team replicated the customer's process in the M Lab™ Collaboration Center and, after extensive investigation, determined that the integrity test failures were a consequence of high pressure pulse in the supply line rather than solution composition.

Outcome:

Partnering with the M Lab™ Collaboration Center team of experts resulted in the customer having a better understanding of process risks, so operations could be controlled to prevent future filter failures. Best of all, this saved the customer time, and the problem was identified without interrupting production schedules.

Challenge:

The customer's product failed to achieve specification of hardness during manufacturing due to poor compressibility of mannitol in wet granulation. They could not change the excipients or process since the product had already been approved in the US and Europe.

Solution:

The team was able to achieve the desired hardness with Parteck^® Delta M (mannitol) excipient in wet granulation through a live demo at the M Lab™ Collaboration Center.

Outcome:

The customer solved their formulation challenge quickly by adopting the excipient that reached the desired hardness during manufacturing and would not interrupt their process or production.

Challenge:

The customer was preparing buffer solutions at very high concentrations, which increased mixing time required and created bottlenecks with existing equipment. In addition, the customer was considering expanding their manufacturing capacity and wanted to explore buffer preparation equipment and hardware.

Solution:

The team invited the customer into the M Lab™ Collaboration Center for two days of hands-on work with products and tools associated with buffer preparation. On the first day, our experts discussed hardware (TFF, Viresolve^® Pro holder, etc.), and on the second day, our single-use specialists performed a mixing demo with the 2,000 L Mobius^® Power MIX. Next, the technical team simulated the customer’s own process and recipe at real scale, which was an extremely powerful way of showing the customer how easy the mixer was to handle in their unique process scenario.

Outcome:

The customer is planning to extend their pilot plant capabilities, and following their visit, they expressed strong interest in implementing Mobius^® Power MIX (1,000 L or 2,000 L) as part of this initiative. The customer also scheduled follow-up demos of our single-use TFF devices and the Mobius^® FlexReady Solutions for TFF.

Challenge:

The customer was looking for a way to increase their mixing productivity and processing flexibility.

Solution:

The technical team and single-use experts worked with the customer to customize two single-use mixers, and a demo was performed in the M Lab™ Collaboration Center.

Outcome:

The combination of excellent support at the M Lab Collaboration center and quality product design demonstrated during the demo (low working volume, good drainability, option to include diverter plate) led the customer to replace their existing stainless steel tanks with two customized Mobius^® Power MIX Single-use Mixing Systems.

Challenge:

A cell and gene therapy customer recently adopted our Mobius^® MyWay Program to address their speed-to-market challenge and wanted to explore further options for single-use implementation at two GMP suites they were building.

Solution:

The team at the M Lab™ Collaboration Center showcased our full suite of single-use technologies, including mixers and bioreactors. The customer engaged with our experts, had detailed discussions, and gained a good sense of the support network we could offer them.

Outcome:

The visit to the M Lab™ Collaboration Center solidified the customer’s confidence in our single-use expertise, and future visits are scheduled to help them prepare to open their new GMP suites and work towards their goal of accelerating access to health.