Keys to Successful Implementation of Single-Use Technology

 

As biopharmaceutical projects occupy an increasingly larger share of the development pipeline, drug makers are striving to implement strategies that bring affordable therapies to market quickly and cost effectively.
Over the past several years, the adoption of singleuse technology has emerged as one important strategy for improving downstream and upstream processing while avoiding the downsides of traditional stainless-steel bioreactors.
Uptake of single-use technology shows no signs of slowing. A recent market report predicted the single-use market will become a $6-billion industry by 2024, marking a compound aggregate growth rate of 11.1% from 2015 to 2024.1
While drug companies are highly motivated to use single-use solutions to speed the development of new molecules, increase production efficiency, and decrease capital expenditures, they still face several complicated challenges such as on-time delivery of materials, regulatory issues, and quality questions.
How are innovators addressing these issues and bringing single-use solutions to the next level?

Single-Use Challenges and Opportunities
While many teams can implement single-use systems to some degree, not everyone has the knowledge and experience to do it well. Some firms believe they are restricted to a one-size-fits-all approach for single-use assemblies. In reality, “singleuse” cannot be implemented the same way for every molecule and every project. A knowledgeable third-party expert can efficiently develop single-use assembly elements tailored to a given project while the sponsor company focuses on making its molecule as productive as possible.
At the M LabTM Collaboration Centers, sponsor companies have access to the Mobius® MyWay portfolio, allowing them the flexibility to choose from three single-use assembly routes. Mobius® Stock solutions can ship within 24 hours for clients with immediate needs. Mobius® Select assemblies give sponsor companies with accelerated timelines the option of using custom assemblies from an optimized component library (six-week lead time). Last, Mobius® Choice offers fully customized solutions for endusers with specialized requirements (standard lead time). This diverse portfolio helps us address the many different needs and challenges that users face.
But with the many choices available to them, how do companies choose the best assembly for their project?
We believe having input from a knowledgeable expert as well as state-of-the-art process development tools are key for designing the best prototypes possible. This pairing—expertise and innovative tools—enables projects to quickly move from the draft stage to one that is fully optimized.
Using our non-GMP facility for this work helps spark creativity and allows end-users to explore the full breadth of options available to them. Clients can troubleshoot unit operations freely with modern tools for both small- and large-scale projects without being bound by regulatory restrictions and standard operating procedures. Experts are committed to helping with demonstrations, evaluations, and education about single-use solutions to quickly optimize and implement applications across various processes.
To support such intricate process development teamwork, we chose to establish our nine innovative M Lab™ Collaboration Centers across the globe which include a host of virtual tools for remote discussions and troubleshooting. Centers are located in North America, Latin America, Europe, and Asia, and we tailor our approaches to the various regional dynamics.
The individualized support and guidance offered at the global M Lab™ Collaboration Centers also helps with any regulatory and validation concerns that arise. For instance, sponsor companies often want to know how to generate the best data for testing processing materials for extractables and leachables. The team at the M Lab™ Collaboration Centers is committed to addressing questions like this and creating a transparent way to supply data-backed critical information and solid best practices about our technologies in support of process validation and optimized manufacturing protocols. Regardless of where in the world this work takes place, we align our training and educational materials and tailor it to the situation at hand.
This collaborative effort is not only critical for new projects, but also for facilitating the streamlined transfer of projects from a traditional stainless-steel manufacturing process to one designed around single-use technology. Working with a knowledgeable partner helps avoid time and resources lost to errors and retesting.

Collaboration in Action
A collaborative approach brings together great people and great minds, overcomes barriers, and accelerates progress. We feel this strategy leads to robust best practices that customers can confidently implement in their manufacturing processes. What follows are four examples that illustrate how partnering in a creative M Lab™ Collaboration Center environment played an important role in the success of customer projects.

CASE STUDY 1: Importance of global network
A contract manufacturer located outside of the United States did not have a fully automated single-use TFF system to produce clinical material for a US-based client. The manufacturer needed to see what such a system would look like and immediately decide on a strategy to implement. Using a virtual demonstration, we responded very quickly and showcased appropriate systems. We then invited the client to an M LabTM Collaboration Center in the United States, so they could not only see the most appropriate system, but also discuss the intricacies of the process and how it would translate into recipes they could run. This type of customer engagement would not have been possible without the interconnectivity of our various regional M Lab™ Collaboration Centers.
The contract manufacturer and their client were both very happy with the end result and implemented the system successfully.

CASE STUDY 2: Higher protein concentrations
The need for higher protein concentrations in bulk drug substances is increasing. One client asked us to collaborate on the use of a 500-L single-use mixer to uniformly mix a viscous drug product without risking protein aggregation. With a joint project team, we designed a set of experiments and showed in an M LabTM Collaboration Center that our mixers worked well while maintaining drug product quality.

CASE STUDY 3: Virtual solutions
One client had key team members based in Asia, Europe, and the United States, and wanted employees from all these areas to discuss a specific unit operation. M LabTM Collaboration Center specialists ran the experiment at our Massachusetts Center with the client’s team members in the United States, while other individuals watched the experiment in real time from sites in Europe and Asia using our virtual tools.

CASE STUDY 4: The power of education
The authorities in Singapore wanted to prepare the local workforce for the influx of new biopharmaceutical R&D and manufacturing projects coming into the country. Because our experts have been deeply entrenched in the industry and regional regulatory issues for years, we were able to train employees of biopharma companies based there and well as regulatory personnel. This collaboration was important to us because we believe an educated workforce is vital to the success of a project—especially in emerging markets where employees may not all have the same degree of regulatory and practical experience in the biopharmaceutical industry. Our involvement in industry consortia like the BioPhorum Operations Group plays a major role in our ability to help clients on this front.

Summary
As companies move away from traditional stainless-steel bioreactors and explore new technologies for accelerating timelines and slashing costs, single-use solutions have come to the forefront as an important option. To fully take advantage of this powerful technique, collaborating with a third-party provider that has an established framework and tools for testing and exploring possible single-use platforms alongside clients is essential for maximizing efficiencies and cost savings.

References
1. Single-use Bioprocessing Systems Market: Customizability as per Consumer Requirements Key Feature Driving Adoption, reports TMR,” Sept. 27, 2016, http://www.transparencymarketresearch.com/pressrelease/single-use-bio-processing-systems-market.htm

As seen in Biopharm International



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