The Rapidly Evolving Landscape of Contract Biologics Manufacturing

Scorpius BioManufacturing is a contract development and manufacturing organization (CDMO) based in San Antonio, TX, that focuses on mammalian- and microbial-cell production at the 200-L and 500-L scales. The company specializes in process optimization during phase 1 and phase 2 development to improve a client’s speed to market. Scorpius’s boutique CDMO operations enable flexible working relationships. Joe Payne (president and chief operating officer (COO) of Scorpius) discussed his company’s strengths in a 2024 Ask the Expert presentation.

Payne’s Presentation

Scorpius began operations with three objectives: ensuring quality, focusing on science and delivery, and providing scalability. The company’s manufacturing operations span multiple modalities, including protein drugs and cell therapies. Using a broad spectrum of technologies, Scorpius can help clients to expedite timelines by helping to create bespoke production strategies. Focusing on 200-L and 500-L processes enables the company to perform contract work according to lean manufacturing principles, decreasing costs while increasing flexibility.

Consolidation is prevalent in the volatile CDMO environment. Several large players in the industry partner with drug developers frequently; however, many such CDMOs have relatively slower and more expensive processes. Bringing complex biologics to market is a multifaceted process that requires collaboration among many stakeholders. Service providers must be flexible with clients so that they can adjust plans together.

Choosing Your CDMO: Payne posed a question: How might a US-based customer choose between a domestic CDMO and one located in a different country? Many overseas CDMOs offer solid solutions, but the market is generally oversaturated with underprepared service providers. Some such manufacturers have staffed up quickly to provide capacity solutions, but they might not focus on establishing quality by design (QbD) from the onset of operations. Problems can arise once production begins, leaving customers in reactionary states rather than proactive dialogues with their CDMO partners. Customers also can experience problems with different time zones and regulatory requirements in other countries. In such cases, partnering with a domestic CDMO such as Scorpius, which puts QbD first, can provide greater benefits to clients.

Single-Use Technologies: Scorpius implements single-use technologies for its operations. Such systems help to mitigate risks of cross-contamination. Stainless-steel systems, on the other hand, can increase production timelines because of their need for regular cleaning and associated validation activities.

Scorpius leverages protein-expression platforms from Cytiva and Thermo Fisher Scientific for its upstream activities. Both platforms use a breadth of operational controls that enable users to address many aspects of batch-production optimization in mammalian and microbial operations. The platforms also facilitate process changeover for increased efficiency.

Operations Transition: Scorpius began as a research-based organization before transitioning to development and manufacturing. As an independent consultant, Payne facilitated the company’s transition by implementing a quality management system (QMS). Over seven months, a new operations team was created, and Scorpius entered the supply chain of biologics manufacturing.

Questions and Answers

What biosafety levels can Scorpius accommodate? We work with many drugs in SafeBridge categories 1, 2, and 3. Although we prefer working at an occupational exposure band (OEB) level of ≥1 µg/m³, we hope to provide further contamination controls in the future.

When will Scorpius release its first good manufacturing practice (GMP) batches? We currently have the systems and the workforce needed for our GMP batches. We are executing clinical activities and planning to release GMP batches beginning in Q3 2024.

Does Scorpius perform standalone process development? Yes, we provide such services. We look forward to working with clients that have unique challenges. Not all products that we encounter will stay with us for commercial manufacturing, but we want to further your process development as needed. Such collaboration creates relationships for the future as well, so we recognize early manufacturing stages as opportunities to address needs in the biologic field.

Find the full webinar online at www.bioprocessintl.com/category/webinars.