RepliGen's OPUS "Open Platform User Specified" chromatography columns have been intentionally designed to offer users unparalleled flexibility in biological purification. With a completely configurable and disposable pre-packed platform, the OPUS column can accommodate a wide range of purification and polishing applications for vaccines, monoclonal antibodies, and recombinant proteins. Compared to traditional chromatography columns the simplified design of the OPUS platform allows for faster product changeover, favorable economics, and improved usability. The move toward disposable bioprocessing and the implementation of more flexible facilities is becoming a standard in many of the world's leading biopharmaceutical companies. As with any paradigm shift, overcoming barriers to implementation is critical, and the downstream purification of biologics had a critical need for pre-packed disposable chromatography columns. The OPUS column is configurable for nearly any bed height and accepts virtually all commercially available filtration resins. The fully ergonomically designed handles allow for effortless transport through the lab, while easily accessible inlet and outlet ports streamline the typically labor intensive set up process. Not only has the OPUS column been developed to be configurable for specific packing procedures, release tests, and storage solutions, but it maintains a unified design across the product platform. This intuitive design supports a simplified and consistent workflow across different column sizes, which aids scale-up, reduces labor and enhances usability, productivity, efficiency, and ultimate speed to market.
Mario Gonzalez IDSA, Ryan Hall IDSA, Michael Miller IDSA, Ben Clement IDSA, Peter Rezac, Tim Vanderpoel and Neal Anderson
Preexisting reusable chromatography columns require intensive cleaning, sterilizing and resin packing procedures between each use, which consume time, incur costs, and increase the risk of exposing users to potentially harmful byproducts. To reduce this harmful risk and eliminate down time, RepliGen's OPUS columns offer a uniquely configurable disposable chromatography platform which customers receive ready-for-use. While RepliGen is widely known for their filtration resins, media, and growth factors, OPUS was their first product in the process equipment space. This meant that the OPUS columns needed to exemplify an effective and intuitive design that supports a simplified and consistent workflow across different column sizes, all while defining a brand language that would introduce RepliGen to the market in a new capacity. The design challenge for OPUS became a balancing act of developing a new and innovative configurable family of chromatography columns that promote an improved user workflow, ensure consistent purification results, and reduce the risk of environmental exposure to harmful byproducts, all while staying true to a unified design language. In order to achieve this goal the team needed to enhance the user experience and meet each stakeholder's unique requirements. These ranged from RepliGen's requirement to manufacture and fill each column in house in a low-throughput but high-precision process, to the end user's requirement for easy transport, set up, and operation in a variety of different lab and production environments. The product line also needed to be configurable to each customer's specific application while simultaneously meeting stringent purification performance criteria.
The OPUS columns set themselves apart from other traditional chromatography columns through a holistic approach. Unlike other chromatography columns available, the OPUS columns address the needs of today's fast-growing pharmaceutical and biotech industry by providing unparalleled configurability, precise purification, enhanced usability, and simple and safe disposal. The flexibility of the system and intuitive design simplifies user workflow across different sizes, which aids scale-up, reduces labor and enhances usability, productivity, efficiency, and ultimate speed to market. By offering this family of columns to various pharmaceutical and biotech companies, RepliGen is helping to enable the smaller-scale and more customized vaccines and proteins in small production runs, which in may ultimately help provide treatments and cures for less prevalent diseases.