Optimising pharmaceutical contract outsourcing Siegfried

OPTIMISING PHARMACEUTICAL CONTRACT OUTSOURCING

Siegfried is a global leader in process development for specialised products and customised contract manufacturing services to the pharmaceutical industry. Philip Yorke spoke to Marianne Spaene, the company’s EVP of sales, marketing and global business development, about its unique out-licensed portfolio and the global trend towards high-potency products.

Siegfried was founded in 1873 by pharmacist Samuel Benoni Siegfried, who began by supplying medical products to pharmacies. From the outset it was a success and by 1904 it was converted to a joint-stock company and was subsequently listed on the Swiss Stock Exchange in 1973. In the late 1980s the company transformed itself into a leading CMO player. Today it is a truly global organisation with a unique range of contract production capabilities and services that cover chemistry, continuous flow technology and formulation technologies, as well as micronisation and spray drying technologies. In addition, Siegfried offers a range of fully integrated services along the entire supply chain, as well as services relating to regulatory affairs, intellectual property, project management, packaging and logistics.

As a preferred partner to more than 60 per cent of the world’s pharmaceutical companies, manufacturers both large and small rely on Siegfried’s long-standing pharmaceutical and chemical heritage as well as its in-depth knowledge of drug production and licensing. Furthermore, as a global company serving pharmaceutical manufacturers worldwide, Siegfried has continued to invest in new manufacturing capabilities. More recently, investment has been focused on additional technologies in the US and Zofingen and in the expansion at its drug product manufacturing facility in Malta. This is in addition to establishing a manufacturing presence in Asia, by which the company plans to gain a competitive edge in its CMO business.

Increased potency products

In the fast changing world of pharmaceuticals, the demand for drugs with higher potency levels and pharmacological activity shows no sign of abating. Since 2004 Siegfried has continually invested in advanced ‘containment technology’ to offset the potential occupational health hazards and possible threats to the environment of these ‘super-drugs’. However, the company’s significant investment in special containment measures ensures safe

operation through all phases of development and manufacture. Siegfried offers its customers the capability for early stage development, scale-up and commercial manufacture of high-potency drug substances and drug products with occupational exposure limits (OEL) ranging down to 1ug/m3.

Spaene said. “We are a true contract development and manufacturing company offering a broad range of chemistry and formulation options. We focus on being an integrated supplier and concentrate on developing and optimising chemical processes as well as difficult-to-make formulations for our customers. Our portfolio of APIs (Active Pharmaceutical Ingredients) is extensive and we have developed new products in the opiates and nicotine areas and are able to develop and market these mainly in the USA and Europe but also in the emerging societies. Our capability for the development of new opiates in North America is particularly important for us because government legislation there means that opiates cannot be imported.”

Spaene added, “We are very much an innovative, integrated contract supplier that offers bridging technologies using crossfunctional teams. The increasing trend towards producing molecules that offer higher potency levels and pharmacological activity is another area that we have been investing in for many years and today we operate state-of-the-art, segregated, high containment facilities and production areas that we consider to be ‘best-in-class’. We are also able to offer continuous cross-flow technology that is not restricted to batches. This in turn reduces analytical costs.”

Optimising the pharmaceutical value chain

Unlike many of its competitors, Siegfried is able to support and project manage the whole pharmaceutical value chain process from start to finish. The company’s goal is to build up a sustainable and stable relationship with its business partners by offering a range of supply chain solutions that are customised to suit a customer’s specific requirements. As an integrated partner, Siegfried offers its clients synergy, expertise and added value through reduced supply chain complexity

and simplified communication. In addition, clients benefit from a reduced vendor interface as well as a combined and coordinated analytical and manufacturing approach that achieves the optimum required formulation performance. Siegfried also provides complete life-cycle management services from development through to commercial and generic realisation.

Spaene commented, “We are not in the distribution business; our focus is clearly on contract development and manufacturing in addition to offering our own portfolio of products. From our sites in Zofingen, Pennsville and Malta we can provide everything along the entire value chain including formulation development and small-scale sample manufacture. We operate a ‘key client strategy’ and are not only serving the big pharma companies, but also the mediumsized companies and those with only one or two products in their portfolio. As soon as we have a project in place we appoint a project leader to manage the team of chemists and regulatory experts, which means that the customer not only has just one point of contact, but also access to our technical information and cost-effective project management processes.”

Creating value through innovative technology

In exclusive partnerships with its pharmaceutical customers, Siegfried develops and optimises processes for the manufacture of new active ingredients and final drug dosage forms. The shared goal of these joint activities is to increase value for its customers through innovative drug development and the protection of a customer’s intellectual property rights. Regarding Siegfried’s own portfolio of products, which are developed and manufactured for different customers, the company continually strives for innovative approaches and the expansion of its own IP portfolio. This strengthens its competitive position and thereby enhances its customers’ own competitive edge.

Siegfried also creates value through its dedicated approach to project management by guaranteeing that its customers can rely on ‘on-time’ delivery of all deliverables, known as ‘on-time-in-full’ logistics. This service is combined with simplified outsourcing processes.

“We aim to decrease our customers’ outsourcing complexity by helping to free up internal resources across the board, which in turn creates more value for our clients.” concluded Spaene. n