Company achieves next major manufacturing milestone and advances global commercial strategy
Menlo Park, CA – January 8, 2024 – Antheia, the pharmaceutical ingredient manufacturer transforming essential medicine supply chains, today announced it has completed a successful validation campaign for its first product, thebaine, consisting of three consecutive full-scale fermentation runs at 116,000L to demonstrate process efficacy and consistency. With the successful completion of this next manufacturing milestone, Antheia is rapidly advancing its commercial strategy to bring its Biosynthetic key starting materials (KSMs) and active pharmaceutical ingredients (APIs) to its leading global pharmaceutical customers.
“Achieving process validation with a novel bio-based process in just one year is phenomenal and speaks volumes to the technical capabilities of our R&D and operations teams,” said Zack McGahey, COO of Antheia. “As a company, we’ve demonstrated the viability and robustness of our platform at commercial scale and have established the foundation for the future of resilient pharmaceutical supply chains.”
Completing a successful validation campaign in a short time frame is the result of Antheia’s focused efforts to develop streamlined engineering solutions for its first product. The company will continue to invest in engineering and process optimizations to improve production throughput of thebaine, which will also bolster production and commercialization of Antheia’s broader pipeline of KSMs and APIs in 2024 and beyond.
“Achieving this next milestone of a successful validation campaign comes on the heels of a hallmark year of transformative growth for Antheia and is a testament to our team’s unwavering dedication to ending drug shortages,” said Christina Smolke, PhD, CEO and co-founder of Antheia. “We saw widespread industry commitment to our first products in 2023 and as we begin a new year, we are laser-focused on our commercial strategy to ship our first orders in 2024.”
Antheia successfully achieved its first major commercial milestone in 2023 and unveiled the first products in a pipeline of 70+ pharmaceutical ingredients spanning seven critical therapeutic areas. The company also expanded its leadership team in 2023 with the addition of Richard Sherwin, SVP of Commercialization, Jesse Ahrendt, SVP of Quality Assurance and Regulatory Affairs, and industry veteran, John Nicols as Chair of Board of Directors. The company’s continued success at full manufacturing scale further cements its platform as a next-gen solution for resilient, agile, and controlled pharmaceutical supply chains.
Antheia is the next-generation pharmaceutical ingredient producer transforming essential medicine supply chains to end drug shortages. Using its novel whole-cell engineering approach, Antheia’s biomanufacturing platform enables the reconstruction of biosynthetic pathways of unprecedented complexity in yeast cells and the scaling of fermentation processes to commercial levels. This highly flexible approach enables on-demand, agile, and resilient biomanufacturing of critical pharmaceutical ingredients, replacing legacy approaches that cannot support the needs of modern healthcare. For more information, visit www.antheia.bio.
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