PCI Pharma Services (PCI), a global contract development and manufacturing organisation (CDMO), announced a significant expansion of its facility in Tredegar, Wales, UK, designed to help keep pace with the market growth of powerful, targeted oncology therapies.
Key highlights:
- PCI is expanding it's manufacturing capabilites to a new facility in Tredegar, Wales, UK to help address the growing need for speciality global CDMOs in oncology.
- The expansion includes two new facilities dedicated to the manufacturing and packaging of solid oral-dose tablets and capsules.
- A replica of CMF1’s large-scale granulation suite and a down-flow booth with containment screening will also be designed.
- Oncology treatments also accounted for 25% of all medicines approved by the FDA between 2010 and 2019, signaling that oncology will remain a key focus for the industry in the upcoming years.
“We’re excited to announce the latest expansion in Tredegar that will address the growing and urgent need for specialty global manufacturing services within the oncology arena,” said Salim Haffar, chief executive officer, PCI Pharma Services.
“As the market expands for potent therapies and highly complex, concentrated formulations that can present unique challenges to manufacturing and packaging, we’re proud to be one of the few providers with the global capabilities to manage this specialty at both clinical and importantly, commercial scale.”
The expansion includes two new facilities dedicated to the manufacturing and packaging of solid oral-dose tablets and capsules. A second contained manufacturing building (CMF2), capitalising on the success of the original CMF1 which opened in 2013, will double large-scale processing capacity including dispensing and fluid bed granulation of high-potency solid-dose products at the commercial scale. In addition, there is a new high-potency, multi-product packaging facility with primary and secondary blistering and bottling suites. The primary and secondary packaging lines provide a fully integrated process, delivering end-to-end services for a global client base.
More than 1,300 medicines and vaccines in clinical trials were indicated for cancer treatment in 2021, compared to 1,100 two years prior. Oncology treatments also accounted for 25% of all medicines approved by the FDA between 2010 and 2019, signaling that oncology will remain a key focus for the industry in the upcoming years.
“The rapid evolution of oncology pipelines has coincided with the continued globalisation of clinical development,” said Rebecca Coutts, Ph.D., general manager, Tredegar, PCI Pharma Services. “This latest investment, along with the existing analytical and formulation capabilities, combines a clinical and commercial scale packaging facility to complement the existing clinical and increased commercial scale manufacturing capabilities, placing end-to-end services for these high-potency molecules under one roof to better serve our client’s evolving needs.”
Both facilities will contain qualtity equipment, including a replica of CMF1’s large-scale granulation suite and a down-flow booth with containment screening. Duplicating the original CMF1 facility will provide both greater capacity and business continuity for clients.
The Tredegar expansion is also expected to create up to 40 new jobs in the first year and add more as the facilities scale up. PCI Tredegar currently employs close to 500 people, almost doubling the number of employees since the opening of CMF1 in 2013. PCI has been operating in Tredegar UK for nearly 40 years and is one of the most significant employers in the local area.