In general, what are some industry issues biopharmaceutical manufacturers are currently dealing with in order to be competitive in the market?
Andrew Bulpin; Executive Vice President, Process Solutions; Millipore Sigma
Biosimiliars, emerging markets, novel therapies and adoption of next generation processing technologies are just a few of the many market dynamics impacting the biopharmaceutical industry. Drug manufacturers are taking a hard look at how to reduce costs, while increasing their flexibility and productivity.
Many biopharmaceutical manufacturers are turning to single-use technologies for their flexibility, cost savings, speed and reduced risk. Flexibility is highly beneficial to multiproduct facilities that produce a variety of different products at different scales. Single-use also helps lower costs by reducing plant footprints and upfront capital spend, as compared to traditional stainless steel facilities. A third benefit is speed. With single-use, there is no need for clean-in-place or steam-in-place, and no need for validation of these operations, which greatly reduces the time it takes to get a facility up and running. Finally, single-use reduces a drug manufacturer’s risk profile. As the name suggests, once you use the product you discard it and install a brand new sterilized assembly, so the risk of product carry-over is eliminated. In addition, due to the closed nature of single-use, you have better biological and viral contamination control.
MilliporeSigma provides the industry’s most comprehensive portfolio of high quality products, services and testing for biopharmaceutical manufacturing, including single-use.
Single-use and disposable technologies have shown their worth in biopharmaceutical manufacturing. However, there are still challenges to working with these technologies. Can you tell us about these challenges and what is being done to eliminate any issues?
Although single-use provides many benefits to drug manufacturers, there are also challenges to be considered. With the implementation of single-use, there is a major shift or “outsourcing” of validation. With traditional stainless steel facilities, drug manufacturers define, own and control the validation strategies associated with sterility, cleanliness and stability. With the implementation of single-use, the ownership of these key strategies shifts from the drug manufacturer to the single-use supplier. For this reason, it is critical to select a single-use supplier with experience, expertise and a strong quality management system.
At MilliporeSigma, we pride ourselves on being problem solvers. The Process Solutions business unit collaborates with drug manufacturers to work through these challenges and help bring life-enhancing drug therapies to market, faster.
In particular, the issue of consumables has become a major concern when working with single-use technologies. Can you describe the current situation and how the topic of consumables has become a major issue/concern for biopharmaceutical manufacturers?
With traditional stainless steel manufacturing, the number of consumables needed to run a process is limited to cell culture media, process chemicals, resins and filter elements. Additionally, production plans are driven by turn-around time, or the time it takes to clean and sterilize vessels between batches. With single use, the number of consumables needed to run the process significantly increases. Varying supplier lead times and delivery delays can impact production plans, which can adversely impact the ability to supply drug products to market.
Many single-use suppliers also have their own proprietary single use components, such as films, filtration devices, connectors, and tubing. This makes it very challenging for drug manufacturers to dual source the consumables needed to run their processes, so they are forced to manage the risk by holding large quantities of safety stock or perform testing to justify that two different products are “like for like”. For these reasons, many users are looking to standardize and harmonize their single-use assembly part numbers, and build a library of preferred components.
As a supplier/vendor of products for biopharmaceutical manufacturing, what technologies and expertise can you offer to a biopharmaceutical manufacturer? What strategies can you offer a biopharmaceutical manufacturer to reduce and manage the amount of consumables?
In January 2017, MilliporeSigma launched the Mobius® MyWay portfolio, designed to help biopharmaceutical manufacturers implement single-use with speed and an increased level of supply security, but also provide a scalable operational model to keep pace with single-use growth. The portfolio offers three options.
Mobius® Stock covers standard catalog items and high-volume repeat custom assemblies. With this option, we maintain stock of the assembly part number on our shelf and deliver when needed, allowing users to maintain less inventory.
Mobius® Select gives users the ability to design configured assemblies from an optimized, prequalified component library or design space, and receive them within six weeks. We maintain safety stock of every component in this library, and provide all the required quality and regulatory documentation, thus enabling fast implementation and reliable delivery.
The third option is Mobius® Choice, which allows users to design customized single-use assemblies, using our full Mobius® component library, and receive them with a traditional lead-time of 12–14 weeks. MilliporeSigma offers support in evaluating single-use assembly designs from across user sites and global networks, to help identify areas of opportunity for standardization and harmonization. Part number harmonization reduces the total amount of different assemblies that need to be managed, thus simplifying procurement, inventory and change management. Additionally, the use of a prequalified design space can reduce qualification costs and speed up implementation.
As the pharmaceutical industry increasingly becomes more global in nature, how can you help a biomanufacturer navigate through increasingly stringent and varying regulations and how can you assist them to meet their global supply chain needs and requirements?
MilliporeSigma’s deep-rooted industry experience and application expertise is relied upon by drug manufacturers worldwide. We are a global organization, with both single-use and regulatory experts based in different geographies around the world. We have over ten years of single-use design, engineering, quality and validation expertise, as well as a network of M Lab™ Customer
Collaboration Centers, which offer scientists and engineers a non-GMP environment where they can test, optimize, analyze, and troubleshoot in real scale without the strict requirements of their own production facilities. We are also actively engaged in different industry consortiums that are currently defining the standards associated with single-use technologies.
We will continue to collaborate with drug manufacturers, as well as other single-use suppliers, to standardize test methods for single use systems, and to ease the implementation and regulatory filing challenges associated with single-use.
We are defining the future and leading the evolution of drug development and manufacturing of life-enhancing drugs, increasing the quality, safety and access to patients and at a reduced cost.
Finally, looking ahead, do you see any industry trends developing that will significantly affect the dynamics of the biopharmaceutical industry, and if so, how will you position your company to meet the needs of your current and future clients?
Emerging countries are driving the need for modular and flexible, quick scale-up facilities. MilliporeSigma continues to see strong growth in the emerging markets and we are expanding single-use manufacturing capabilities in Asia to support drug development in this fast-growing region. By the end of 2018, we will have a single use manufacturing facility in China for Mobius® Select assemblies.
Next generation processing will also have a significant impact on how our customers bring new therapies to market, delivering them to patients faster and more cost-effectively than ever before. This new approach has the potential to make a significant shift in the industry. Next Generation has three key elements: Process Intensification, Single Use, and Process Analytics. These are key strategic focus areas for us and the highest levels of our organization are committed to leading the industry in this process evolution, structuring our organization with dedicated teams working on new innovative technologies and applications in these areas. For decades, MilliporeSigma has, does and will continue to collaborate with our customers to shape how drug production is done today, and will continue to shape the possibilities of tomorrow.