SUNDERLAND, U.K.—For the second time in recent months, Onyx Scientific has announced a major expansion of its facilities to meet an uptick in demand for its contract research and small-scale active pharmaceutical ingredient (API) manufacturing services. The latest plans for expansion come following a year in which the company achieved what it is calling “the best performance in the company’s 15-year history.”
Onyx plans to increase its current facilities in Northeast England by about 30 percent, and has already recruited several new chemists.
“Although we have come to the end of a very positive year, we have never been a firm to rest on our laurels,” said Onyx Commercial Director Denise Bowser in a press statement. “With the support of our parent company Ipca Laboratories, we are very much investing in our physical capacity, equipment and technical resource.”
The latest plans for expansion come just several months after Onyx announced that it was adding to a new cleanroom suite designation as Class 100,000 under good manufacturing practice (GMP) regulations. The company said the new suite was needed due to an upsurge in Phase 1 and 2 GMP campaigns from clients in Europe and the United States.
“We have worked with hundreds of clients at the small-scale non-GMP stage and have been able to provide rapid scale-up to GMP for many of them with the same technical team, all under one roof,” said Bowser. “So by having an additional GMP suite at our disposal, it gives us even greater flexibility to assist our clients that are under increasing timeline pressure to deliver against their development programs.”
Last year, Onyx made yet another investment in its facilities by expanding its continuous flow manufacturing capabilities. Continuous flow manufacturing is a method of processing that is rapidly becoming commonplace within the pharma industry. Onyx says that improving its continuous flow processing was intended to allow its customers to explore alternatives during product research and development programs.
Since its launch 15 years ago Onyx has partnered with many pharmaceutical, biotech and specialty drug development firms to provide contract chemistry, development and production services. The company’s facilities now allow for the production of API in up to 50-liter to 100-liter equipment under current GMP regulations, a scale that fits naturally with its early-stage custom synthesis, lead optimization and analytical services. Onyx typically works with firms in the early stages of drug development and production, but its clients are also able to scale up using parent company Ipca Laboratories’ large-scale manufacturing sites in India.
“The decision to expand into an additional building has been driven by increased demand for GMP services as well as continuous flow projects and solid-state chemistry, which has fully utilized our resources over the past 12 months,” said Bowser. “It’s been a challenging few years for CROs across the industry, but our team has continued to work hard to always exceed clients’ expectations, which has led to a very loyal customer base and regular repeat business.”
Mumbai, India-based Ipca Laboratories, which acquired Onyx in 2011, hit a rough patch recently due to regulatory concerns. The company received a warning letter from the U.S. Food and Drug Administration last month regarding failures to comply with GMP regulations at three of its India plants. The letter followed import alerts issued by the FDA in 2014 and 2015 that banned the plants from supplying to the United States. The FDA’s actions have no direct impact on Onyx.
“We remain committed to supporting drug developers across the globe with routine chemistry and overcoming early-stage complex chemistry challenges to allow them to progress, scale up and meet clinical deadline with robust lead candidates,” says Bowser.