A new pilot plant at UK firm Aesica's Cramlington site has filled a void in the active pharmaceutical ingredient (API) specialist's offering, allowing them to provide services all the way from Phase I through to product launch.
The new small scale pilot plant will be used to produce small quantities (10kg - 100kg) of compounds for Phase I/II clinical trials, a scale Aesica's existing facilities were unable to cater for.
"We had a gap between 1kg and 50kg," Robert Hardy, Aesica's CEO, explained to in-PharmaTechnologist.com.
"With the new plant we have the whole range and can support clients from Phase I right through to launch of their products."
The company already has a network of five computer-controlled, good manufacturing practice (GMP) compliant, multi-product plants located at its UK sites in Cramlington in the Northeast of England, and Ponders End in North London. Between its facilities, the company can now cater to companies requiring volumes just above pilot scale right through to hundreds of tons of product.
The GMP-compliant pilot plant will also provide the company with valuable process information and experience, which it intends to exploit to improve its own full-scale commercial manufacturing operations.
Today's announcement comes after the first of a four to five phase project for the pilot plant, which has been housed in an existing building at the Cramlington site and constructed over the last six to nine months.
The first project at the new pilot facility will begin within the month, with several more already earmarked to follow close behind.
Aesica specialises in supplying APIs and custom synthesis services to the pharmaceutical industry, counting a number of industry leaders among its client base. The company was formed following a management buyout of the specialist pharmaceutical manufacturing business of chemical firm BASF in 2004, and has grown significantly over the three short years since its formation.
Just under a year ago the company acquired the Ponders End facility from Merck Sharp & Dohme (MSD), gaining it a 300 ton-per-year capacity plant and significantly increasing the firm's manufacturing capacity.
The deal also included a multi-year supply agreement to provide MSD with intermediates and APIs over a number of years, resulting in a potential revenue stream of $150m-$300m (€111m - €222m) for the company.
Aesica is also in advanced talks with another of its customers, Abbott, to buy its chemical and pharmaceutical manufacturing facilities on the Isle of Sheppey in Kent. This deal is also likely to be supplemented with a supply agreement, whereby Aesica will take over production of a number of Abbott products currently manufactured at the site.
The sale is hoped to be complete by the end of August, providing Aesica with even greater manufacturing capacity and moving the company into the production of formulated products.
Given the strides the company seems to have made over the first three years of its independent operation, it is unsurprising that it has no plans to slow down in the near future:
"Within three years we intend to become the leading supplier of APIs and formulated products to the pharmaceutical industry," said Hardy.