The Newburn facility near Newcastle, UK cost £6m ($10m) to construct and yesterday the company announced it had received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to begin commercial production.
Newburn will ensure the company has the capacity to deal with increasing demand coming from clients at SCM’s nearby clinical manufacturing facility - which deals "with novel new clinical trial projects that need developing and small scale sterile manufacturing" - looking to scale up towards commercial production, Managing Director at SCM Dianne Sharp told Outsourcing-Pharma.com.
Furthermore, she added the new facility will allow the firm to deal with licensed products in niche markets on the lower end of the volume scale.
“This has been our sweet spot for several commercial clients over the last few years and we have seen increasing demand in-line with the trend towards personalised medicines.”
Operations are set to begin at the back-end of summer with an oral syringe filling project for an undisclosed EU client with a dedicated suite put in place along with filling and packaging equipment.
According to Sharp, this reinforces the manufacturing progression that the company hopes to provide with the facility:
“We carried out the clinical supply of this product and are now the commercial supply partner with Newburn at the hub of the operation.”
Last month the company was named as commercial supplier for BTG’s candidate treatment for varicose veins, Varisolve, which – if approval is granted – could prove lucrative for both BTG and SCM.
The 26,000 sq ft site includes a range of packaging and labeling areas, temperature controlled warehousing, raw materials and engineering preparation, visual inspection and leak testing, and has led to a 45% increase in staff at SCM, jumping from 75 to 110.