Pharma must focus on processes

The pharmaceutical industry is at a critical point in its history where it must shift away from spending millions on new drug development and instead focus on better manufacturing, according to one trade body.

In an article entitled “Milking out a profit or is this an industry on the turn?”, North East Process Industry Cluster (NEPIC) chief executive Stan Higgins claims that the pharmaceutical industry is at a critical point where it must reassess its priorities because “R&D performance of the pharmaceutical industry over the last 12 years has become something of a nightmare for the sector despite so much of the industry’s cash being poured into the research portfolio”.

This poor R&D performance is verging on a disaster for many large pharmaceutical companies

NEPIC chief executive Stan Higgins

“This poor R&D performance is verging on a disaster for many large pharmaceutical companies that have built business strategies based on profits from bringing new products to market,” writes Higgins.

“We have already seen the impact this has had in the UK with a fall in R&D capability such as the withdrawal of Pfizer research almost completely from the UK. The current business model of pharmaceutical companies relies too heavily on the need to get new products into existing and new markets as rapidly as possible in order to maximise the benefit from a limited patent life. Cleary focusing on an industry strategy that relies on innovation alone is not working for the pharmaceutical industry.”

As a result, says the article, “more and more companies” are coming to “realise that manufacturing efficiency and better control of operating costs has a bigger role to play in their strategic plans”.

Higgins calls for a “strategic approach that really drives the whole value chain”, and there are signs that such changes are already taking place.

Speaking in the February issue of Process Engineering, Robert Hardy, the chief executive of contract pharmaceutical manufacturer Aesica, said that there was a growing trend for many big pharmaceutical companies to contract out the manufacturing process for their products in order to achieve greater efficiency.

“It’s been a long time coming, but some of the big American pharmaceutical companies are well on the way to outsourcing a high percentage of their products,” he said.

It’s clear with the price pressures brought to bear on large pharmaceutical companies they have to outsource more because they are not going to get the cost benefits within their organisations.”

Contract manufacturers, said Hardy, are able to be more cost competitive because they can run their plants for multiple customers, unlike big pharma firms who will often have plants “operating at only 20% capacity”.

Firms such as Aesica are also seeking to further improve their efficiency and reliability by bringing in technologies commonly found in other process sectors, such as continuous production. Hardy said this was a significant step for an industry dominated by batch processes.

The idea of different batches having different quality profiles is something that the regulators are trying to get away from

Aesica chief executive Robert Hardy

“We are looking at a lot of cutting edge stuff – we have continuous tablet processing capabilities at our Queenborough site [a tablet production facility in Kent],” said Hardy.

“There is this push towards continuous technology that is being driven by the regulators, the idea of different batches having different quality profiles is something that the regulators are trying to get away from. If you can have continuous production with the same quality throughout, that’s the utopian position.”