3PBIOVIAN strengthens its end‑to‑end CDMO offering with state‑of‑the‑art sterility testing, from clinical to commercial
3PBIOVIAN has significantly strengthened its sterility testing capabilities, reinforcing its position as an integrated, end‑to‑end CDMO serving biopharma customers from early development through commercial supply.
Sterility testing in isolators is required to achieve the highest level of sterility assurance and regulatory confidence. By minimizing operator intervention and environmental exposure, this approach significantly reduces the risk of contamination events, test failures, and inconclusive results. At the same time, isolator‑based sterility testing supports shorter release timelines, lowers long‑term operational costs, and strengthens confidence among both clients and regulatory inspectors.
The expanded sterility testing platform supports development through clinical and commercial manufacturing, enabling seamless project progression without reliance on external laboratories. This in‑house capability provides a streamlined approach, allowing greater efficiency, control, and confidence across the full product lifecycle.
Sterility testing is a core analytical competence at 3PBIOVIAN, with nearly three decades of experience analysing a wide range of product types, including protein‑based and viral products. This capability is routinely used to support internal manufacturing activities across the company’s two sites.
The recent investment builds on this extensive expertise, combining long‑standing know‑how with a state‑of‑the‑art facility and advanced equipment. By integrating Drug Substance and Drug Product manufacturing with critical analytical testing under one roof, 3PBIOVIAN continues to deliver a robust, reliable, and fully aligned development and manufacturing pathway from early clinical stages to commercial production.
ABOUT 3PBIOVIAN
3PBIOVIAN is a globally operating Contract Development and Manufacturing Organization (CDMO), delivering end-to-end services for biotech and pharma companies. Their service offerings include protein expression and production platforms based on microbial strains and mammalian cells, plasmid DNA, viral vectors for adenovirus and adeno-associated virus for gene therapy, and cell therapy products. Additionally, they provide fill and finish services for recombinant proteins and viral vectors. The company has manufacturing facilities in Pamplona-Noáin, Spain, and Turku, Finland, efficiently supporting the diverse needs of their clients, covering everything from preclinical and clinical supply to large-scale commercial manufacturing for drug substance and drug product.
