The technology – known as Veriseq Nucleation – uses a freezing mist that is introduced into lyophilisation chambers where it spreads evenly and rapidly, providing nuclei – or seeds -around which ice crystals form in a uniform and predictable way.
This is potentially very significant for biologics and vaccine makers because current methods of controlling crystal formation, such as sudden depressurisation or post-lyophilisation annealing, are costly, inefficient and can substantially extend cycle times.
A Linde Gases spokeswoman told in-Pharmatechnologist.com that tests on sucrose, mannitol and the antibiotic vancomycin HCL show that in addition to shorter cycle times the technology has other potential benefits for manufacturers.
“[Veriseq nucleation enables] more efficient removal of moisture leading to shorter operating cycles, due to better ice structure as evidenced by scanning electron microscopy of dried product and tunable diode laser absorption spectroscopy (TDLAS).”
She added that the approach also provides greater vial-to-vial uniformity, reduces the number of vials that break during freeze drying and improves the visual appearance of the final product.
Linde also claims that biologic drugs and vaccines processed using Veriseq can be reconstituted three to four times faster than those freeze-dried using traditional approaches, which the firm believes has implications for physicians and patients.
“From a patient administration perspective as an average nurse pharmacist is less likely to shake a vial for more than 30s when trying to dissolve a powder prior to injection administration.”
Veriseq nucleation was developed and tested in collaboration with IMA Life North America, the unit of Italian firm IMA Industrial Machinery SpA that supplies industrial lyophilisation systems, but can be applied to a wide range of platforms.
“It can be retrofitted on all lab and commercial systems, not just the ones made by IMA,” the spokeswoman explained, adding that it “will be made available through a freeze drying original equipment manufacturer OEM for both new as well as retrofits. Details of this will be announced in the near future.”