Pfizer CentreSource has decided to outsource the manufacture of some of its active pharmaceutical ingredients (API) to two Asian contract manufacturers and intends to work with the Food and Drug Administration's (FDA) during the process.
The pharma heavyweight has enlisted the firms, ScinoPharm* of Taiwan and Shanghai Pharmaceutical Co. of China to "enable more cost-efficient API production" and the two firms are now adding manufacturing capacity to deal with the new contracts. Pfizer will transfer the late-stage processing of 18 steroid API and intermediate products to the new manufacturing partners in three phases over the next four years, beginning with the commodity APIs that involve the less sophisticated chemistry first.
"Outsourcing these finishing steps will prove very beneficial for us as these steps are very costly to conduct currently in our US plant," spokesperson for PCS global contract manufacturing division, Carlos Fernandez, told Outsourcing-Pharma.com at the recent CPhI show in Paris.
"We will soon be able to bring more competitively priced steroid APIs to the global market and we expect the first of these to be available on the market by early 2008," he said.
The firm said it will still continue to do the early-stage bioconversion operations at its US plant in Kalamazoo, Michigan.
"We wanted to keep the more technical and complex early-stage processes in-house," said Fernandez.
Pfizer is adopting the new strategy as it feels the squeeze from the barrage of low-cost Asian API and intermediate producers that are flooding the market and eroding its business, along with that of most other Western fine chemicals manufacturers, many who, like Pfizer are seeking new strategies as well as offshore locations and partnerships in a bid to remain in the game.
In this latest move Pfizer has also undertaken an interesting course, believed to be the first company to receive acceptance from the FDA to implement a comparability protocol for these Asian-made API ingredients.
Previously comparability protocols have only been implemented by the FDA on finished dose products.
As a result, Fernandez said that Pfizer will undertake a parallel quality control testing of the APIs, first of all at the Asian locations where the processing is conducted and then at its shadow lab in the US as a second-line measure.
"Switching from one raw material provider to another can be unpredictable so in this way our customers can be assured that the FDA has reviewed their product," he said.
When posed the question as to why such an approach had not been taken by the FDA with any company before, Steven Grieve, the newly appointed director of technical development and regulatory affairs, said "I believe it is because no one else has asked."
"Pfizer has been trying to work with the FDA in may ways to achieve better science - our head of quality is very involved with process analytical technology (PAT) - and he approached the FDA for advice on what was the best way forward in this situation and this is what they suggested," explained Grieve.
"From a company standpoint, this may become the standard way forward for Pfizer's next initiatives in China."
Meanwhile the firm has also become the 16th company to join other big industry names such as AstraZeneca, GSK, ICI and Johnson Matthey in the Britest process improvement organisation, focused on bringing a more innovative approach to manufacturing process design in pharma chemical manufacturing.
Britest methodologies work through a "toolkit" to analyse processes and determine potential improvements to yield, quality, throughput, and reliability that can be achieved through improvement of conventional batch manufacturing operations, or the application of process intensification techniques.
"Britest is doing some exciting things that will help us to better understand our manufacturing processes and enable us to change the way we do things in the future," said Rick McCabe, global manufacturing senior manager of Pfizer.
*UPDATE July 31 2014 - the deal between ScinoPharm and Pfizer has since fallen through