Ralph Brandenberger - Dark Horse Consulting

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years of experience

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years at DHC

Ralph

's Service Domains

CMC

Regulatory

Quality & Compliance

Business Analytics

Ralph is a resourceful Technical Operations leader with broad experience in cell therapy and biologics in startup environments and established organizations. He brings to DHC his 24 years of experience in development and manufacturing of clinical stage cellular therapeutics & biologics, cGMP master and working cell banks, and biologics process aids used in commercial API manufacturing.

Prior to joining DHC in July 2025, Ralph was Chief Technical Officer at Nkarta Inc. Ralph joined Nkarta in 2018 to lead the process & analytical development, Quality, manufacturing, and supply chain strategy of Nkarta’s allogeneic NK (Natural Killer) cell platform leading to successful INDs for Nkarta’s two product candidates. He built and developed the internal Technical Operations organization and oversaw an external manufacturing and supply chain network for drug product, viral vector, starting materials and raw materials with production of 100+ GMP lots internally and externally. His work included supporting the design, construction and startup of a clinical manufacturing facility and design and construction of a commercial manufacturing facility for production of allogeneic CAR-NK cells.

Prior to Nkarta, Ralph led process development for two early-stage cell therapy companies, Neurona Therapeutics and Geron Corporation. At Neurona, he developed the strategy for translating production and characterization of pluripotent stem cell derived GABAergic inhibitory neurons from research to entry to clinic, as well as sourcing of hESC lines suitable for GMP manufacturing.

At Geron Corporation, he led process development for Geron’s human embryonic stem cell (hESC) therapy platform. His team developed an optimized hESC derived cell therapeutic manufacturing process with improved purity and yield. Ralph was also responsible for technology transfer to pilot production and GMP manufacturing. Earlier during his tenure at Geron Corporation, Ralph was responsible for development of scalable manufacturing technologies, including successful long-term expansion of hESCs and differentiation to target cells on micro carriers in single-use disposable bioreactor. He championed and managed a corporate collaboration to develop synthetic surfaces for hESC culture resulting in launch of the Corning^® Synthemax^™ Surface.

In addition to his cell therapy expertise, Ralph has technical operations experience in biologics and cGMP cell banking. At Baxter Healthcare and its spinoff Baxalta he was head of Technical Operations at the Hayward GMP manufacturing facility. Ralph was member of the site leadership team, and led Cell Banking, Manufacturing Sciences, and Analytical Sciences & Services. He oversaw manufacture and characterization of GMP Master Cell Banks (MCB) and Working Cell Banks (WCB), including cell banks supporting commercial products of ~$3B annual revenue sold in over 60 countries. He co-authored CMC sections of BLA/IND filings & post-approval regulatory changes and served as subject matter expert for EMA and FDA audits. Ralph was responsible for upstream cell culture process development up to 250L single use bioreactor for recombinant protein production in mammalian systems and led feasibility studies for 2,000L single use bioreactor processes, new single use technologies, and next-generation cell banking processes. His team was also responsible for implementation of continuous process improvements for robustness, reduced cycle times and process control. He directed implementation of state-of-the-art high throughput cell culture & purification and high throughput/high content analytical platforms for rapid process development and characterization.