Symbiosis confident injectables business will thrive under stricter MHRA

By Gareth Macdonald

- Last updated on GMT

Related tags Pharmacology

Stricter MHRA take requires even greater compliance efforts for injectables CDMOs
Stricter MHRA take requires even greater compliance efforts for injectables CDMOs
Rival injectable drug contractors were felled by a stricter MHRA take on rules says Symbiosis' CEO who is confident his firm's compliance record will help it thrive.

The UK-based CDMO unveiled it plans to expand its facility at Stirling University’s Innovation Park earlier this week​, explaining that it will add injectable drug production capacity and temperature-controlled storage space.

CEO Colin MacKay told us the move was prompted in part by increased drug industry R&D spending, which he said was creating demand for contractors with specialist capabilities.

The current 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 injectable drugs being developed is increasing in proportion.

We are seeing an increase in demand as a result of the high level of regulatory compliance that we offer, which is also a consequence of us building our facility as recently as 2011 with its tailored electronic Quality Management Systems (QMS​)” MacKay continued.

UK capacity

A number of UK injectable drug contractors have been impacted by quality problems in recent years with Aesica​ and SCM Pharma​ being just two examples.

While there have been no significant changes to the rules that cover the manufacture of injectable drugs, “the MHRA’s expectations on the interpretation of the guidelines has become more stringent as demonstrated by license revocations of UK sterile and non-sterile manufacturers in recent years​.”

As a result the ability to adhere to regulations has become increasingly valuable and it is Symbiosis’ “level of compliance is driving the growth that we are seeing as a business within the context of that wider industry demand​” according to MacKay.

He also confirmed that Symbiosis is hiring to meet demand, explaining that that: “Our headcount is already increasing as a direct response, specifically in the manufacturing, project management and quality functions.​ 

The expanded facility is due to be operational before the end of the year.

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