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.
After only 2 months on site, the strip out of the existing building has been completed and the new mezzanine slab constructed. Initial installation of mechanical and electrical services has started and the main fit out work is imminent, in line with the construction programme. The new facility will house the contract development, clinical and commercial manufacturing teams in a new, purpose built facility. This investment is in addition to the previously announced expansion of our analytical laboratories and the ongoing project to introduce serialisation to Custom’s commercial packing lines.
State of the Art Product Containment Facilities
Custom Pharma Services was founded in 1979 as a CMO, focusing exclusively on solid oral dose products. The decision to expand Custom Pharma’s offer into commercial potent molecules has been led by client enquiries and a detailed assessment of the UK’s pharmaceutical manufacturing environment. The pharmaceutical industry is developing more potent molecules whilst simultaneously the understanding of diseases has led to more stratification in treatment options. This core understanding and associated creation of personalised medicines has led to the requirement for smaller commercial batches in “state of the art” product containment facilities. It is important to recognise that Custom will retain its existing capability and capacities for less potent molecules. The new facility will allow our clients to place both “standard” and potent molecules with us.
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” formulation to a more commercially acceptable formulation as early as possible. The philosophy of “develop once, develop right” has been the mantra of Big Pharma for some time 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 to clients a genuine choice for their solid phase product – from simple capsule formulations that will need refining during the clinical programme to a more complex formulation option, from first intent, that can ensure a smoother clinical and regulatory pathway.
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 CDMO and commercial CMO; and the delays caused by switching between large CMO sites. The product knowledge, so carefully learnt during the products development lifecycle, is fully retained within Custom by the integrated team.
The design team who are overseeing the development of this new facility, have been engaged with the regulatory authorities to ensure that the new facility fully meets their expectations. As a UK facility, the MHRA will inspect the facility once the build has 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 manufacture solid oral dose formulations of potent molecules; both for clinical and commercial products. The new facility is expected to be available for development, clinical and potent commercial manufacturing in 2019.