The Role and Benefits of Polymeric Resins in Bioprocessing

Dorie Yontz of DuPont discusses its bioprocessing offering, the role of polymeric resins, and critical elements as they relate to manufacturing.

Recently, DuPont launched a new online sales portal tailored to the needs of bioprocessing industry purchasers. The companybs bioprocessing solutions are designed to enable sophisticated purifications and separations for therapeutics and diagnostics, with established brands such as DuPont AMBERCHROM and DuPont AMBERLITE for the biopharma industry. 
The companybs products are used to purify process streams during drug and diagnostic kit manufacturing. Although these products are not part of the finished formulation, purification resins are critical to final product quality and are therefore selected early in drug development.
The new online store aims to support the bioprocessing market for speed and agility, allowing direct access to DuPont Ls resins in a format suitable for benchtop and early process development phases of drug development.
Dorie Yontz, Global Market Manager, Bioprocessing, DuPont Water Solutions discusses the bioprocessing offering, the role of polymeric resins, and critical elements as they relate to manufacturing. bKB  
Contract Pharma: What were the factors behind DuPontbs addition to its Life Sciences product offering for bioprocessing?
Dorie Yontz: We recognize that drug discovery and benchtop research teams have different needs versus commercial scale manufacturing. Biopharma companies are adopting various strategies to shorten drug development timelines and they need speed and agility when it comes to small-scale product screening. Our online e-store was designed to offer these benefits to our customers and, so far, the feedback has been positive. 
DuPontbs family of purification resins offers high resolution and yield for complicated separations. Our digital store delivers easy and fast access to these products in convenient small-scale packaging for benchtop research. 
Given that the drug pipeline is very diverse, we believe it is important for people to have a means to navigate the product options based on the way they think about their projects, be it based on the type of drug they are purifying, the function they are trying to achieve, or the resin class that they are seeking. The new online store is intuitive and easy to navigate to cater for these requirements. At the same time, users of the platform have access to DuPontbs technical experts for guidance with product selection and troubleshooting, if needed.
CP: Please explain the role and benefits of polymeric resins as they relate to pharmaceutical bioprocessing?
DY: Drug developers have many strategies for designing effective purification processes, depending on the target molecule and type of impurities. There are numerous parameters that factor into polymer resin design and we have a portfolio of options within the ion exchange, reverse phase chromatography resin, and adsorption resin families. Resin characteristics such as particle size, pore size, accessible surface area, resin chemistry, and mobile phase influence the capacity, resolution, and separation kinetics of the purification process.  
Once the best resin for the drug has been identified, the process needs to be scaled and transferred to manufacturing. Development scientists and process technology transfer teams appreciate that our resins consistently perform across a wide range of conditions and readily scale-up, so that they can have confidence in transitioning the drug process through the development phases to commercial manufacturing.
End-users also like that our products are robust. The ability to withstand many cleaning cycles without loss of performance is key in extending the time between replacements.  For example, DuPontb" AmberChromb" chromatography resins are stable to a wide pH range and can therefore be more aggressively cleaned compared to silica alternatives, which offers consistent performance and long lifetimes. 
Due to the increasing complexity of the drug pipeline, there will be greater focus in the future on resin selection and adapting the eluent system to meet the unique purification needs of each drug. This customization will rely on greater collaboration between researchers and resin suppliers, such as DuPont, during drug discovery and scale-up. 
CP: What are the critical elements as they relate to manufacturing?
DY: Drug manufacturers need to ensure consistent supply of safe and effective medicines at prices patients can afford. As a key component of the purification process, polymeric resins separate target drug molecules from impurities, while minimizing loss of precious drug product; therefore, resin resolution and its impact on drug yield and purity are critical in a manufacturing environment. Reliable resin supply with on-time delivery and consistent quality batch after batch are also vital since the complex regulatory environment leaves drug manufacturers with limited flexibility to adjust to supply issues. Time is money, and production up-time is a key metric for manufacturers. This means they need to have confidence that their supplier is trustworthy with knowledgeable support staff who can help them when technical issues arise.  
For decades, DuPont has been a premier supplier of polymeric ion exchange and chromatography resins that are used in drug processes around the world. Our comprehensive product line and technical expertise allow for exceptional performance in even the most complex manufacturing processes. As a global company, we have operations and technical support staff around the world to help manufacturers with their resin purification processes, from discovery, to clinical trials, to commercial manufacturing.
CP: What solutions are available for all phases of drug development from discovery to large-scale commercial production?
DY: DuPontbs purification resins have scalable performance from benchtop to commercial production, so the solutions for different phases of drug development are tailored based on convenience for the user. For drug discovery, where researchers often want the convenience of a pre-packed column, resin is available in HPLC column formats. We also have resin in small quantities for those who prefer to pack their own columns. The small sizes are easy for researchers to handle and provide an affordable way to test a range of products so they can see what works best for them.  
For large-scale commercial production, we offer a range of polymeric resins including reverse phase resins, fine mesh anion exchange resins, fine mesh cation exchange resins, and adsorbent resins. These products are manufactured in large commercial facilities and can support large volume processes with consistent quality from batch to batch.
We are giving our customers an easy route to quickly test our products and select the right one for scale-up, helping them streamline their development and get to market quicker.

Dorie Yontz is the Global Marketing Manager for Bioprocessing, part of the Life Sciences and Specialty group within DuPont Water Solutions (DWS) business.  Before joining DWS in 2016, she spent 7 years leading a wide range of projects at a start-up company dedicated to the development and commercialization of specialty bio-based chemicals. Prior to that, Dorie had a 10-year career with The Dow Chemical Company, serving in a variety of R&D and market development roles across multiple businesses.  She has an MBA from Northwood University and a PhD in Polymer Science and Engineering from the University of Massachusetts, Amherst.