Symbiosis Pharmaceutical Services, a small company launched last year in Scotland, has gotten approval from U.K. regulators for its new plant for APIs and biologics.
The company said in release that it will manufacture sterile liquid, lyophilized, conventional, cytotoxic and biological drugs at the new facility in Stirling, Scotland, which it said it was able to get up and operating in what it believes is record time.
"Symbiosis is proud to have built, qualified and licensed its new manufacturing facility within a matter of months, achieving a timeline never seen before in the industry," Colin MacKay, CEO and founder of the contract manufacturing organization, said in a release. He said the plant has two manufacturing suites, one of which is capable of handling cytotoxic and highly potent pharmaceuticals, but that the company is focused more on speed than size, specializing in products for clinical trials.
"Our intention is to be both the fastest, and the best, small-scale sterile fill/finish company in the world," MacKay said.
He said the company's approach to the plant's design, seeking input from clients, and the speed in which it was raised reflect the approach around which it intends to cement its reputation, flexibility and responsiveness to achieve fast turn-around times for drugmakers.
The company will make biologics in addition to the small-molecule drugs that will make up the biggest part of its production, MacKay told Outsourcing-Pharma. He said the plant is "cross-recognized" by the FDA.
In that regard, Symbiosis joins other companies that have opened biologics plants in just the last few months. Belgian drugmaker UCB Pharma in September completed a €65 million ($84.8 million) biologics plant so it could manufacture products it had been outsourcing. Eisai subsidiary Morphotek in August opened a 60,000-square-foot, $80 million plant in Exton, PA, which will allow it to produce multiple biologics simultaneously.
- here's the release
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