Lifecore Biomedical Inc.’s recently installed high-speed, multi-purpose 5-head isolator filler is GMP-ready and operational. The CDMO is now positioned to offer existing and future customers the speed and aseptic isolation benefits of this technology for fill/finish services for prefilled syringes, vials, and cartridges. By installing and qualifying the 5-head isolator filler, the company has more than doubled its current capacity.
 
“As the industry evolves to comply with increased controls such as the EU’s Annex 1 requirements, we are thrilled to now have our high-speed 5-head isolator filler GMP-ready and operational. The system enables us to offer quality and safety enhancements to our global customers and their patients while providing operational efficiencies in support of our organizational growth,” said Paul Josephs, president and CEO of Lifecore. “Combined with a robust Quality Management System, a proven regulatory track record, and unique expertise in handling complex formulations, we believe this new technology positions Lifecore as a leading partner for aseptic fill/finish CDMO services.”
 
Lifecore believes that the addition of the flexible 5-head isolator filler will not only improve the company’s leadership position in the development and fill/finish of highly viscous and complex formulations, but will also help diversify its customer base by supporting new projects for less viscous and less complex protein, peptide and antibody products. Furthermore, the new filler offers speed and quality control enhancements, critical areas of focus for manufacturing today’s most advanced injectable pharmaceutical and biopharmaceutical products.
 
“We are highly encouraged by our ongoing conversations with both new and existing customers regarding their interest in accessing this new capacity and capability,” said Darren Hieber, senior vice president of corporate development and partnerships at Lifecore. “What is particularly exciting is that we are not only talking to companies that recognize us for our expertise in working with challenging formulations, but we are also having discussions with potential customers whose products represent more straightforward production processes. We believe we have demonstrated that Lifecore is equally adept at fulfilling the needs of both types of companies and look forward to leveraging the 5-head filler to serve additional customers.”