Last week Vindon Scientific opened the doors to its new 8,100 sq ft facility in Santa Fe, California, offering biopharmaceutical storage solutions to Californian and West Coast drugmakers, just months after it announced plans to up capacity at another storage facility in Ireland.
Patrick Jackson – Director at Vindon Scientific – told Biopharma-Reporter.com though the expansions have been driven by an overall increase in demand for controlled storage, in his experience biomanufacturers “are not as inclined to outsource storage solutions as small molecule manufacturers.”
This is “possibly due to the need to have the samples close to the research site, or possibly due to the high cost of the material,” he said.
Biopharma partnerships with service providers are becoming increasingly important he added, as “in the interrelated multi-layered world in which Vindon operates, competition is becoming increasingly intensified with outmoded business models being thrown out,” as firms look to significantly decrease their costs.
Third-party firms in general “enable pharmaceutical and Biopharmaceutical companies [to] reduce their fixed cost base and become more flexible,” Jackson told us.
With firms increasingly losing exclusivity on topsellers and “a fourfold increase since 1970” in gaining regulatory approval of an NME (new molecular entity), “the consensus amongst independent market analysts is that this trend will increase considerably.”
Biopharma-Reporter.com also spoke with Lindsay Haney, Operations Manager at Vindon Claifornia, about how a site needs to cater to specifically store biopharmaceuticals.
As well as ensuring the facility is GMP compliant and has a complete backup and security solution in place, it is necessary “to ensure the temperature and/or humidity ranges are maintained at all times,” she said, with a monitoring system compliant with regulatory guidelines (in the US Title 21 CFR Part 11 of the Code of Federal Regulations for the US Food and Drug Administration).
Furthermore, she continued, it is necessary to have properly trained staff following Standard operating Procedures (SOPs) and “appropriate means of transportation for product shipment.”
Jackson added: “The problems in storing biopharmaceuticals instead of small molecule drugs is not an issue as we have put people, equipment and systems in place to address all activities relating to biologics."
This is further bolstered by “clear communications with the client company, an understanding of the various requirements of the regulatory bodies involved and a [full] risk assessment,” he said.