Further to Custom Pharma Services’ earlier announcement on the commencement of the building work on its £20 million investment in a new, high containment development and manufacturing facility in Moulsecoomb, Brighton; we are pleased to provide an update on its progression.
The strip out of the existing building has been completed and the new mezzanine floor constructed. Installation of mechanical and electrical services has progressed well and the main fit out work is already partially complete. In parallel, we continue to procure new automated high containment process equipment from the industry’s leading suppliers. The contract development, clinical and commercial manufacturing teams will all operate together in a single new, purpose-built facility. This investment is in addition to the previously completed expansion of our analytical laboratories and the project to introduce serialisation to Custom’s commercial packing lines which goes live in January 2019.
State of the Art Product Containment Facilities
Custom Pharma Services was founded in 1979 as a contract manufacturing organisation (CMO), focusing exclusively on solid oral dose products. Both Custom and the wider pharmaceutical industry continues to develop highly potent products. Mankind’s greater understanding of disease has led to stratification in treatment options and hence an increased requirement for smaller commercial batches in state-of-the-art, high containment facilities. Whilst satisfying this demand it is important to recognise that we will also retain our existing capability and capacities for less potent molecules, which will transfer to the new facility to a carefully constructed programme. This allows our clients to continue to place both standard and potent molecules for both development and commercial supply at Custom with complete confidence.
Clinical Development
In the clinical arena, Custom is seeing an increase in the potency of molecules and concurrently, a wish from pharmaceutical companies to switch from a simple “drug in capsule” formulations to more commercially acceptable formulations as early as possible. The philosophy of “develop once, develop right” has been the mantra of major pharmaceutical companies for some time in order to reduce their time to market and clinical costs. Within this facility, Custom are investing in both capsule and tableting capabilities for potent clinical development and commercial manufacturing. Custom has the capability to offer clients a genuine choice during the product lifecycle for their solid phase product – from simple capsule formulations for early clinical programmes to more demanding commercial formulations for complex products whilst ensuring a smooth clinical and regulatory pathway.
All-in-One Site
The team at Custom works for clients of all sizes, from virtual pharma to large multinational, who wish to develop their potent new chemical entity or their new generic (or super generic) product. The ability to deliver clinical and commercial products from the same facility allows our clients to avoid the delays caused by switching between separate clinical contract development organisation (CDO); and the delays caused by switching between large CMO sites. The product knowledge, so carefully learnt during the products development lifecycle, is fully retained by Custom for commercial application by the integrated team.
Regulatory Authorities
The design team which is overseeing the development of this new facility, has been engaged with the regulatory authorities to ensure that it fully meets their expectations. As a UK facility, it will subject to a full MHRA inspection once the build and associated validation activities have been completed.
Custom Pharma’s new development and manufacturing facility has been designed from the ground-up to be multi-regulatory agency friendly and will allow Custom Pharma Services to expand the manufacturing solid oral dose formulations of potent molecules; both for clinical and commercial products. Our fabulous new high containment facility is targeted to be available for highly potent development, clinical and commercial manufacturing.
