UK-based sterile filling firm Symbiosis Pharmaceutical Services has expanded its presence in the US through the recruitment of an East Coast-based business development manager in order to help service the demand for sterile manufacturing.
The growing demand “is directly linked to several industry-wide factors,” according to CEO Colin MacKay, including “the number of drugs in the collective drug pipeline of the global biopharma industry, and the proportion of those drugs that will be administered by injection,” he told Outsourcing-Pharma.com.
“Fuelling all of these is the amount of finance recently raised to fund biotech in the US in particular,” he continued, but added that “on a less positive note, there have been some high profile examples of sterile manufacturers being challenged as a result of regulatory non-compliance both in the US and in the UK,” further driving demand for sterile manufacturing and lyophilization capabilities.
Boehringer Ingelheim’s US subsidiary Ben Venue Laboratories - the oldest, and one of the largest, contract developer and manufacturer of sterile pharmaceuticals in the world – finally shut its doors after years of regulatory compliance issues last January, while across the pond 2014 saw such CMOs as Aesica and SCM Pharma exit the injectables sector.
While MacKay told us “compliance is of paramount importance,” Symbiosis is hoping to offer its US clients “a level of service excellence which exceeds our clients’ expectations,” in order to successfully capitalise on the growing demand from US firms.
In terms of capital investment in the US MacKay said the firm “needs to keep an open mind in terms of developing its future strategies,” but in the meantime it has a facility in Stirling, Scotland that has manufacturing capacity for Symbiosis to grow into.
“A future physical presence in the US would provide an opportunity to add further value to our clients and our wider stakeholders, but only when the timing is right,” he said. “In the meantime we have a clear strategic plan to developing our presence in the US market and are very busy implementing it.”
We asked MacKay whether providing such services to the US from the UK would cause any regulatory issues, and while he admitted there are a number of relatively minor differences between EU regulators and the US FDA for sterile fill/finish and the GMP manufacture of injectable drugs, the industry, he said, is becoming increasingly harmonised.
“We have seen the regulators become increasingly pragmatic over that past 10 years while ensuring absolute compliance. Like any specialism, the thought leadership is continually advancing and that translates over time into guideline revisions which reflect an industry which is changing dynamically.”
Last month Symbiosis appointed Derek Richards, a commercial executive with 20 years of experience in the pharmaceutical industry to oversee its business development activities across the East Coast and is looking to appoint a senior executive to look after commercial interests on the West Coast.