Schott starts mass production of TopLyo vials

By Gareth Macdonald

- Last updated on GMT

Schott begins commercial scale production of its TopLyo vials in a bid to meet growing demand for packaging solutions for freeze-dried bio-drugs.

At present, up to 50 per cent of drugs in development include biomolecular elements such as proteins, polysaccharides and carbohydrates, and the market is expected to grow considerably in the coming years.

Unlike traditional small-molecule pharmaceuticals which are fairly robust, biomolecular drugs can be highly sensitive to changes in temperature and atmospheric conditions, usually requiring that they must by lyophilised for shipment.

However, while freeze-drying solves stability issues, this type of processing can increase the tendency of drugs to adhere to the interior surfaces of vials in which they are packaged, resulting in high-levels of overfilling and wastage.

Schott’s new TopLyo vials, showcased at AAPS 2009 last week, are coated with smooth 40nm thick hydrophobic layers designed to prevent adherence as company spokesman Gary Waller explained.

Basically this is a combination of two process, the lyophilised bottom process that we’ve matched up with our plasma impulse chemical vapour deposition (PICVD) coating on the inside surface…”​“

Waller also told in-PharmaTechnologist that the primary market for TopLyo is any type of biopharmaceutical for which attachment and absorption to vial surfaces during production has hitherto been a problem.

Schott began commercial-scale mass production of TopLyo at its manufacturing facility in Muellheim, Germany on November 8 and estimates that the plant will produce up to six million units a year.

The vials, which are also designed to withstand sterilisation processes and heat treatments of up to 300ºC, are currently available in 2ml and 10ml versions although Schott plans to roll-out a 6ml version later this year.

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