As a production line ages, it becomes incapable of delivering products that meet current regulatory requirements. However, it is difficult for many pharmaceutical companies to justify the huge investment needed to upgrade or replace it. Outsourcing the production of injectable ampoules to a specialist contractor is one of the most efficient and cost-effective solutions.
It has been estimated that pharmaceutical companies would need to invest around E10 million to install a new or upgraded injectable ampoules production line. With the global contract manufacturing market expected to exceed $26 billion by 2011, it is important for contract manufacturers to offer innovative, real-time services to stay ahead of the competition.
The cleanliness of the manufacturing site should always be of the highest quality, ensuring constant sterility of the water and air-conditioning system. Personnel must wear protective clothing at all times and the machines have to be kept on, even during weekends and holidays. All equipment must be sterilised before it comes into contact with the ampoules.
These processes reduce the risk of contamination from dust particles and dirt.
By taking all these safety measures, a class-C cleanliness is achieved. Such a high level of cleanliness is extremely expensive to maintain, and increases the running costs of the plant.
This considerable financial burden is lifted from pharmaceutical companies that outsource their ampoule production, freeing up funds and production space for higher margin products.
Regulations require that no impurities should be found in ampoules, which means a high-standard, quality-control process must be established. This is an additional cost for pharmaceutical companies. At Cenexi, expensive optical inspection equipment is used to check for three main nonconformities while a member of staff carries out random inspections at the end of the line.
Cenexi employs a pinhole detection machine for ampoules and vials. The machine uses a high-voltage electrical field and impedance measurement to examine each container at four inspection points, checking for hairline fissures and pinholes, leaking ampoule neck tips, insufficient glass thickness at the tip and absence of fill. Such machines are very expensive, employing the latest in high-frequency, high-voltage technology. They ensure the reliable, accurate and non-destructive inspection required to comply with rigorous industry standards for high-quality and safe products.
Another advantage of transferring production to a contract supplier is that the existing production line can remain in use while work is processed, establishing and validating the contractor's facilities. This helps minimise the risk of supply interruptions. Without a contract supplier, the pharmaceutical company would have to build up large stocks of certain drugs, which is costly, inconvenient and, in the case of short-lived products, may even be impossible.
Cenexi offers a complete solution from manufacturing to delivery as well as employing a dedicated team to deal with registrations of injectable ampoules worldwide. Pharmaceutical companies outsourcing their ampoule production to Cenexi can focus on the market, letting a reliable and resourceful partner take care of their supply needs.
Cenexi is a contract manufacturer of pharmaceuticals for human and veterinary markets. Production began in 1923 with the manufacture of syrups followed by high-quality vitamins in the 1950s and benzodiazepines in the early 1960s. It now manufactures solid dosage forms and injectable ampoules for the global market.
With drug producers under great pressure to reduce prices, one contract manufacturer argues that the industry should consider contracting out at least some of its production.
Downward price pressures, escalating drug development costs, stricter validation requirements and unpredictable market futures all affect pharmaceutical companies' decision-making when it comes to investment in production facilities.
Apart from the high cost of new drug development, the expensive and time-consuming compliance with stricter GMP and/or FDA validation requirements make investment in new manufacturing plant prohibitive at times.
Other driving factors include rising energy prices, direct labour costs and other overheads. While both big pharma and smaller drug producers are affected by all of these factors, contract manufacturers can aid cost containment and help shorten lead times to market by taking responsibility for manufacturing technology, validation and packaging.
Findings published at the end of 2001 by the Tufts Center for the Study of Drug Development in Boston, USA showed that the average cost to develop a new prescription drug is $802m. Moreover, it still takes up to 15 years to develop a new treatment, from patenting the molecule to reaching the market.
Every pharmaceutical manufacturer and contract manufacturer is acutely aware of the need to comply with all the regulatory requirements for each product and every market served. At Cenexi for example, the company must comply with a large number of regional health authorities, all of which make regular inspections. It must also satisfy all the overseas authorities in the countries where its drugs are sold. There is also the good manufacturing practice (GMP) standard to which the company subscribes.
Finally, because veterinary medicines are also produced at the plant, there are veterinary standards to meet. All of these require documentation and time, which costs money.
All pharmaceutical companies are under competitive pressure. While everyone in the industry would accept that the time to market a new drug can be unbearably long, new treatments can still be copied by generic producers long before the development costs have been recovered.
One important factor is that development time for a new prescription drug can take up to 15 years and that of a typical molecule patent may last as little as seven years. Competition from generics can hit the original developer even as its own product reaches the market - driving down prices and lengthening amortisation of the development costs.
Contract manufacturers have convincing arguments for the service they bring to a changing pharmaceutical industry. To satisfy the needs of their clients and exploit the growth opportunities inherent in the market, contractors must embrace new production processes, take greater responsibility in the validation and transfer cycle, and undertake firm commitments for both product quality and delivery. If the industry fulfils these criteria, it has a very healthy future.
Cenexi works for human and veterinarian pharma companies. In 2005, it had a turnover of e73m and it estimates that this will reach e80m this year. Cenexi has the capacity to produce 300 million injectable ampoules, from 1ml to 20ml; 1,300 tonnes of solids, hard-gelatine capsules S.1&2 and tablets; ten million units of syrups; 20 million units of suppositories and 120 million items of packaging.
The company offers a full service package and its customers' products are sold in more than 115 countries.