Informex, the exhibition of custom and batch manufacturers, which was held last month in Anaheim, California, provides an opportunity to review recent activity in the fine-chemicals and contract API market. In examining developments from 2012 and 2013 to date, companies are proceeding with select investments to build capacity and service capabilities. Highlights of some of this activity is outlined below.
On the expansion side, Lonza reported on the first two build-out phases of its large-scale multpurpose cGMP API plant in Nansha, China, following FDA approval of several customer projects in late 2011. Also, a new cGMP kilo-laboratory in Nansha and an additional small-scale manufacturing train were successfully brought on line. The company’s large-scale antibody drug conjugates project in Visp, Switzerland was finalized on schedule and the plant received FDA approval in the third quarter of 2012. A second expansion phase has started and will be finalized toward the end of the first half of 2014. Five additional high-potency API (HPAPI) laboratories in Visp, with capabilities for cytotoxic substances, are operational and utilized, and new investment in additional cytotoxic API manufacturing capacity in Visp was started up, according to the company. Lonza also increased peptide-manufacturing capabilities at it site in Braine, Belgium.
Other companies are proceeding with investments and alliances to build HPAPI capabilities. In 2012, Carbogen Amcis and ADC Biotechnology announced a partnership to provide customers with development and manufacturing services for antibody drug conjugates. ADC Bio will provide access to proprietary solid-phase immobilization technologies for conjugation and long-term storage of antibody drug conjugates, and Carbogen Amcis will focus on small- to large-scale GMP supply and on the formulation of antibody drug conjugate. In October 2012, Fujifilm Diosynth Biotechnologies formed a strategic alliance with Piramal for antibody drug conjugate production, whereby the two parties will offer contract development and manufacture of ADCs. Piramal offers antibody drug conjugate production at its site in Grangemouth, Scotland. Fujifilm recently announced an expansion of its cGMP manufacturing facilities at its sites in Research Triangle Park, North Carolina, and Billingham, United Kingdom. Novasep announced in 2012 a $3.9-million (EUR 3 million) investment to expand its highly potent API manufacturing capabilities at its Le Mans, France, facility. The plant expansion is expected to be fully operational by the beginning of 2013. The new Le Mans facility adds to Novasep’s strategy for total synthesis of antibody drug conjugates.
Other companies are proceeding with investment or recently made investments in 2012. Almac expanded its API manufacturing facility at its European Headquarters in Craigavon, United Kingdom, with a scheduled completion for end of 2012. This upgrade includes installation of two 1000-L reactors and a pressure-filter dryer, which allows production of GMP APIs up to 150-kg batch. Cambridge Major Laboratories (CML) is planning an expansion of its large-scale API manufacturing facility in Germantown, Wisconsin. The expansion comes three years after commissioning the new site. The expansion will include additional reactor capacity as well as isolation equipment. Alongside capacity additions, CML has made additional investments in engineering controls to ensure the sustainability of the business. Cedarburg Hauser Pharmaceuticals expanded the capacity of its Wisconsin-based API manufacturing plant as a result of an increased demand for contract manufacturing of commercial APIs as well as additional upgrades for improving safety and GMP systems.
Dr. Reddy’s reports expansion in the areas of activated mPEG manufacturing and in the development and manufacture of APIs for use in preclinical through to commercial development at its manufacturing facility in Mirfield, United Kingdom. Also,in addition to its HPAPI capacity expansion, Novasep is investing EUR 30 million ($39 million) to build a chromatography plant for the production of large volumes of commercial APIs. The plant will be built on Novasep’s existing site in Mourenx, France, and is expected to be operational and validated within 18 months. The new plant will contain Varicol continuous chromatography systems with 1200-mm diameter columns operated at up to 70 bars. SAFC, part of Sigma-Aldrich, is expanding its operations in Scotland by investing in the development of a new powder-manufacturing facility on its Irvine site. SAFC’s new facility in Irvine is its second powder manufacturing facility, which will support SAFC’s risk-management program, providing an internal back-up supplier for its customers. The new facility will be used to service customers across Europe.
Almac and DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM, recently reported the successful transfer of enzymes for enzyme screening, process development and scale-up manufacture, as part of an October 2012 agreement in biocatalysis. The agreement grants both parties access to their enzyme platform technologies and services for the manufacturing of APIs. The collaboration also enables Almac to offer its customers a preferred partner for large-scale production. In other news, DSM Pharmaceutical Products signed a collaboration agreement with Chemtrix in the field of continuous flow chemistry. The collaboration is intended to provide equipment, development, and manufacturing services to the pharmaceutical industry.