BioProgress will install its line at Custom Pharmaceuticals' new pharmaceutical contract manufacturing facility currently being built at Moulescoombe, near Brighton, in the south of England, according to a letter of intent between the two companies.
Custom is a privately owned CMO, established in 1979, which manufactures prescription and over-the-counter (OTC) medicines, vitamins and herbal supplements. Under these proposals, BioProgress will occupy a segregated part of the new Moulescoombe facility and will install one of the film casting lines it purchased from Valence Technology in August.
BioProgress decided to operate its own production for XGEL last year once it emerged that its suppliers were unable to meet the standards required for a pharmaceutical-grade film.
The agreement benefits both parties, with Custom offsetting some of the cost of the facility and BioProgress avoiding the hefty start-up costs of setting up, validating and maintaining its own unit - in effect it can operate 'virtual' in-house manufacturing. And the closer collaboration between the companies will give Custom the opportunity to be an early adopter of some of BioProgress' film-based drug delivery technologies.
The line will manufacture BioProgress' SOLULEAVES, WAFERTAB and FOAMBURST technologies, as well as the films required for its SWOLLO, TABWRAP and NROBE systems.
BioProgress has started to win major contracts for some of these technologies - with the likes of Wyeth, Perrigo and Colgate Palmolive - and these players demand multiple manufacturing lines to safeguard production. The Moulescoombe unit will operate alongside BioProgress' existing facilities at Tampa in the US, but will have three times the capacity, said Graham Hind, the firm's CEO.
Moreover, the structure of the deal - dubbed LOCUM (Low Cost, Out Sourced, Capital Based, Unrestricted, Manufacturing) - will act as a model for BioProgress' expansion into other markets, said Graham Hind, the firm's CEO.
Under the terms of the agreement, Custom will provide the building space to full pharmaceutical standard, and will be responsible for maintaining full European and US regulatory manufacturing approvals for the production of pharmaceutical grade film and film containing pharmaceutical actives.
Custom will provide the necessary personnel for film manufacturing, quality control and quality assurance, as well as the qualified staff to sign off batches of pharmaceutical film products on a cost plus basis. It will also provide raw material and finished goods storage, and access to technical and analytical laboratories. BioProgress will have dedicated office space and meeting facilities for the use of BioProgress staff and customers on site.
Nigel Richardson, chairman of Custom, noted that contract manufacturing of medicines is becoming a fiercely competitive global business, and companies must invest in state of the art facilities like Moulescoombe in order to stay competitive. And this is more the case than ever now that new low cost pharmaceutical manufacturing capacity is coming on line from China and India.
"Dosage forms like SWOLLO, TABWRAP and WAFERTAB which we can see could have a serious impact on the traditional pharmaceutical manufacturing cost model …could offer Custom a significant competitive advantage in our contract manufacturing core business," he said.
Hind said the film casting line should be operational by May 2005.