Bulk filling is an essential step in the global distribution of biopharmaceutical products such as vaccines. “This has become poignantly clear in the global Covid-19 pandemic”, says Michael Matthijssen, sales manager Benelux at Parker Bioscience. “The major vaccines are produced in central hubs, from where they are distributed overseas. Automated sterile filling and coldchain transport have proven to be a bottleneck in this regard.”

Autospomated control

In recent years, Parker Bioscience Filtration has developed a fully automated, single-use solution for controlled freeze-and-thaw and final filling: Scipure FD. “This system can help speed up global distribution”, says Matthijssen. “It tackles a variety of challenges – not just the typical problems concerning the contact points between stainless steel and single use. The Scipure FD removes manual processes, for instance, and uses standard operating procedures, automated monitoring and control.”

The system eliminates open processing in order to avoid contamination. It provides for automated traceability, as part of complete logging of Good Manufacturing Practice (GMP) procedures. It also uses client-specific ‘recipes’ for continuity and repeatability.

Validation

“This system focuses on automating the single-use part of bulkfilling into bottles or bags”, summarises Matthijssen, “but it doesn’t end there. It also ensures for freeze-and-thaw cycles that maintain product integrity, even at temperatures down to -90°C for longer transports. And it includes the tools for complete validation, as well as the software needed to control the entire procedure.” The Scipure FD can work either on its own, or be integrated into the client’s own system.

Parker Bioscience offers its clients on-site assessments and testing, and as well complete annual service. “What’s unique about the whole package is its comprehensiveness: it combines all hardware, software, testing, training and service”, says Matthijssen. “In addition, there’s several unique elements. One is our patented close seal on the bottle systems that has been validated to minus 85 degrees. Another is a J-tube system that diverts the liquid flow to the side of the bottle, which reduces foaming and allows for more controlled filling.” The full single-use manifolds are produced in-house from pre-validated Scilog Select Go design spaces.

Scalability

Parker Bioscience is also developing solutions for downscaling to smaller volumes, for instance for RNA techniques and to allow for smaller volumes for risk mitigation purposes. “Naturally, these smaller-volume processes have to be GMP-compliant as well”, says Matthijssen. “We’ve come a long way, but making this system plug-and-play is still a challenge. For now, we’re focusing on the scalability of single use and automation.”