The landscape of biologics manufacturing is continuously evolving. The shift towards more diversified and advanced therapies is driving the need for robust and efficient viral clearance strategies to ensure safe products reach patients without delays.
The expansion of viral clearance capabilities in Europe, alongside our well-established expertise in the US, reflects the Eurofins network of laboratories’ ambition and commitment to continuous improvement through local access to harmonised, high-quality services.
Among the key factors shaping an effective project strategy are turnaround time and budget optimisation. For this reason, Eurofins BPT Italy launched a new project this year focused on developing co-spiking methods to support clients in managing development programmes more efficiently and accelerating early development phases, process changes, and screening activities.
While multi-spiking is gaining attention in viral removal studies, limited data are available for tissue-based applications. Our purpose is to exploit this tool by simultaneously testing more than one virus in a single study design, significantly reducing timelines and cost.
First experimentations have already delivered promising results, presented at the PDA Virus Conference 2026 in Eurofins BPT’s poster titled, “Empowering the multi-spiking tool in viral safety for pharmaceutical and biologics products.”
Our data show that co-spiking two widely used viruses - Porcine Parvovirus (PPV) and Bovine Viral Diarrhea Virus (BVDV), as referenced in ICH Q5A(R2), does not affect the infectivity detection. Importantly, the inactivation kinetics of PPV and BVDV challenged with glutaraldehyde remain comparable whether tested individually or in combination, confirming that co-spiking does not affect viral susceptibility and can improve the efficiency of viral clearance studies.
The next step is to validate the co-spiking approach on biological matrices, to provide more representative data, in line with our commitment to translate scientific innovation into efficient solutions that accelerate timelines and support successful regulatory submissions. Explore our approach to viral clearance.