The Scotland, UK-based contract manufacturing organisation (CMO) launched a bulk freeze drying service this week, adding cleanroom capacity for aseptic and low bioburden dispensing of bulk materials and explaining that customer demand prompted the investment.
Symbiosis has provided lyophilisation services since 2011. However, the initial focus was “small-to-medium scale batches of liquid and lyophilized injectable drugs” according to CEO Colin MacKay, who told us the expansion reflected changing market dynamics.
“Our offering was knowingly designed to align with the demand we anticipated principally from small-to-medium biotech companies in the US and European markets, however what we have actually seen is demand for our world class capabilities from across a range of biotech, specialty pharma, generic pharma and big pharma clients from all around the world.”
For smaller biotech companies the ability to provide specialist manufacturing services – including lyophilisation – at short notice is key according to MacKay, who said such companies are often dependend on hitting clinical trial milestones.
Larger drug companies are also looking for CMOs with freeze drying capacity, although this demand is driven less by pressure to hit clinical goals than it is by the number of biopharmaceuticals in the product pipelines.
“Some of the physico-chemical challenges of large biological drug molecules invite the use of lyophilized formulations in order for drug product to be manufactured in a stable state and therefore available to make clinical trials possible” MacKay said.
Drugmakers’ need to refill pipelines is also a factor. Mackay said that: “The current high level of finance being pumped into the drug development industry is meaning that a greater total number of drugs are being resourced and therefore advanced into the clinic and to market, and the number of lyophilised drugs being developed is increasing in proportion with that.”