The challenging environment for companies supplying chemicals into the pharmaceutical sector, with a relentless increase in competition, has prompted German company Merck KGaA to start a new service aimed at reducing the workload of its customers.
Emprove, as the new initiative is called, has been launched to bundle chemical supply with a documentation service covering the essential ancillary data, such as product monographs and stability testing results, that can be used to support new drug filings.
There is no question that the approach is novel. Currently, many suppliers of pharmaceutical ingredients leave the onus for stability and other testing on the customer, although some provide this data free as part of the package. Merck intends to develop complete dossiers on the bulk of its chemical products, which will be made available to its customers - at a price.
The cost of a complete dossier - which will contain all the necessary data and any updates for a period of five years - is set at around €7,500, although certain modules will be available separately for a lower price.
Merck's senior manager for the Life Science Materials division, Dr Arnulf Heubner, told In-PharmaTechnologist.com at this week's CPhI show that customers buying ingredients for pharmaceutical applications generally have to conduct their own testing as the onus is on the producer of the medicine to ensure quality.
If you consider that a typical stability test can cost €15,000 to €25,000, the outlay for an Emprove-branded ingredient with a complete accompanying data dossier is relatively modest, he said. And some of the information will continue to be available free of charge, he stressed.
"Emprove offers convenience and time-saving in quality assurance, reduces costs by simplifying processes and rendering regulatory affairs and QA more efficient and increases product safety in production," said Merck in a statement.
This service is unique in the industry at preset, said Heubner, adding that ingredients suppliers are having to find ways to add value to their offerings in order to operate effectively in an increasingly competitive marketplace.
But Merck is also facing the reality of rising costs at a time when the cost of producing ingredients has been rising and prices have been constant, cutting into margins. This is partly the result of rising raw material and energy costs but also the need to maintain ever-growing teams of quality control staff.
Merck maintains a staff of 450 to cover QC/QA and regulatory affairs - some 5 per cent of the 8,000 headcount in production - and across the industry companies are having to maintain an ever-growing QC staff as regulators insist on more stringent standards.
For example, the new pharmaceutical legislation in the EU, implemented last April, is extending the requirement for Good Manufacturing Practice into the excipients field.
Merck has already created the accompanying dossiers for its 85 most important products so far, accounting for around 60 to 70 per cent of total sales, and will add an additional 200-300 by the end of 2006. The Life Science Materials division has a total portfolio of around 600 ingredients.
Heubner also noted that the Emprove service is likely to be extended to cover other services, such as customising ingredients and improved packaging.
For example, at last year's CPhI, Merck launched a new double polyethylene (PE) Safer Sack designed to overcome a problem with conventional sacks, i.e. that contamination adhering to them could be unintentionally carried into clean production areas.
The new design overcomes this problem, by allowing technicians to remove the sterilised inner sack only when inside the aseptic environment. Heubner said that this and other ingredient packaging concepts would be added to the Emprove service.