Exclusives Custom Manufacturing

Custom manufacturing (CM) signifies the Konigsdisziplin, that is, the most prominent activity of the fine-chemical industry. Because of their long experience in safeguarding the intellectual property interests of its customers, it is the stronghold of the Western companies. CM is the antonym of outsourcing. 

The transfer an industrial activity—production or service—that thus far was carried out in-house to a third party through a contractual arrangement. 

Custom and toll manufacturing account for the majority of business between fine-chemical and life science industries. The specialty chemicals industry outside life sciences sources mainly standard products. 

In order to identify the success factors for custom manufacturing, an antagonistic approach is recommended the selection criteria for outsourcing partners, as established by a major pharmaceutical company, are listed in Appendix A.6. Those fine-chemical companies, which best comply with the 28 criteria, obviously have the best chance to become suppliers. The ranking is typically based on an extensive audit of the prospective supplier. 

Business model Project-driven Product-driven 

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Fine-chemical/custom manufacturing companies (discussed in Section 2.1) are active in process scaleup, pilot plant (trial) production, and industrial-scale exclusive and nonexclusive manufacture contract research organizations are discussed in Section 2.2, and laboratory chemical suppliers are discussed in Section 2.3. 

The products offered by the fine-chemical industry fall into two broad categories (1) exclusives and standard or (2) catalog products. Serviceintensive exclusives , provided mostly through contract research or custom manufacturing arrangements, prevail in business with life science companies standards prevail in other target markets. 

Since Lonza carried out its first homogeneous asymmetric hydrogenation on a 17 ton scale in 1994, the development and application of asymmetric hydrogenations has been a major strength in Lonza s technology portfolio. The applications in Lonza have varied from internally-generated projects, for end-products marketed by Lonza, to projects in the custom-manufacturing field, in which the Lonza Exclusive Synthesis department is active. This chapter will illustrate how process de-... 

Substances used only for process-orientated research and development are exempt from registration for 5 years. The exemption can be extended for a further 5 years in exceptional circumstances, or 10 years for substances used exclusively to develop human or veterinary medicines. The manufacturer or importer has to inform the ECA of the substance identity, labelling and quantity, justify the quality, summarise the research programme and list the customers. 

The international standard ISO 9001 2000 specifies quality system requirements for use where a contract between the company and customers requires demonstration of the capability to design and supply the product in compliance with the applicable regulatory requirements and customer satisfaction. The contents of the adopted standard refer to design, manufacture, and final product inspection and testing. No exclusions permitted. 

Many firms can use contractors to manufacture product. This can be done for many reasons, such as a sudden demand to increase production or to accommodate new product lines. Active pharmaceutical ingredient (API) firms usually manufacture exclusively for other sites that make finished product. Regardless of the operation, at some point there will be an audit from aclient or customer firm. 

As discussed in the PMN Exclusions and Exemptions Chapter, 5(h)3 of the Toxic Substances Control Act (TSCA) exempts from TSCA 5(a) and (b) (the PMN and Significant New Use rules, respectively) small quantities of new chemicals or chemicals subject to a Significant New Use Rule (SNUR), if used solely for research and development (R D) purposes underspecified circumstances. R D substances are often sampled for outside testing to laboratories or to customers. If the product is not on the TSCA Inventory, or is the subject of a SNUR, the R D substance must be sampled in a way that meets the TSCA exemption requirements for research and development samples. TSCA s PMN rules apply to manufacturers and importers SNURs apply to processors as well as manufacturers and importers. 

This generalization allows the product to flow through multiple independent retailers. However, the retailers do not interact because end customers are assumed to be captive to a particular retailer (i.e., exclusive territories) and the manufacturer produces enough to satisfy all retailer requests. Recent examples include Ingene and Parry (1995(a)), Chen et al. (2001), Fransoo et al. (2001), Netessine and Rudi (2001(b)). The first considers price-sensitive end demand while the other three include inventory effects. 

Seifert, et al. (2001) assume that the manufacturer has a direct (internet) market that serves a different customer segment than the traditional retail channel (not owned by the manufacturer) and that demands in the two channels are thus independent. They model the inventory decisions for a supply chain comprised of a manufacturer and N retailers, as shown in Figure 15.4. They compare a dedicated supply chain to a cooperative supply chain. In a dedicated supply chain the inventory sent to each retailer is used exclusively to meet demand at that retailer while inventory at the internet store is used exclusively to meet demand at that store. In a cooperative supply chain, leftover inventory at the retailers is available to fill demand at the internet store. 

We have undertaken to sell our products by essentially all the means known to us. In Canada we sell directly. In the United States we sell directly and through non-exclusive agents for particular products and in some cases in restricted locations. Off continent, we sell mostly through agents, by which means we are represented in some 75 countries. We have sought and received help from Canadian Trade Commissioners. We have sold for cash and we have sold for credit. In two countries in Europe, because of customs duties and local competition, we have licensed manufacture of our therapy machines. Every two weeks, on average, our people travel a distance equal to Yuri Gj arins trip around the world. ... 

These negative influences were, however, reflected in the staff development on the site a relatively sharp decrease in the number of site personnel from the end of 1983 from a temporary peak of approximately 3200 to about 1200 people in the summer of 1985, which was largely planned. The problems described later, made it necessary, however, to increase the number to 1900 people by the turn of the year 1985/86 (Figure 3.1). In the middle of 1986, the work force was again roughly up to schedule. In May 1987, only about 350-400 people were still working on the site, almost exclusively commissioning personnel of the manufacturer and the customer. 

At higher temperatures the internal pressure of SO2 cells is also high, up to 30 bar and more. So the geometry of these cells is restricted to round tubes, which may be easily and economically used as pressure vessels. They are manufactured in standard or customized sizes from stainless steel - exclusively hermetically welded... 

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