Informex, the exhibition of custom and batch manufacturers, which was held in February in Anaheim, California, provided 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 expand manufacturing capacity and enhance service capabilities. High-potency manufacturing continues to be an active area of investment among CMOs, and several CMOs also are expanding overall manufacturing capacity.
Lonza, the bellwether of the contract API manufacturing sector, proceeded with several expansions in its small-molecule custom-manufacturing business in 2012. Earlier this year, Lonza reported that its custom manufacturing and bioscience sectors will be regrouped into one pharmaceutical market segments group. In 2012, Lonza completed the first two build-out phases of its large-scale multipurpose cGMP API plant in Nansha, China, following FDA approval of several customer projects in late 2011. Also, the company successfully brought on line a small-scale manufacturing train and a GMP kilo-laboratory in Nansha. 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 in 2012. Lonza also increased peptide-manufacturing capabilities at its site in Braine, Belgium.Other companies are proceeding with investments and alliances to build HPAPI capabilities. In 2012, Carbogen Amcis and ADC Biotechnology formed 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. Carbogen Amcis will focus on small- to large-scale GMP supply and on the formulation of antibody drug conjugates.
In October 2012, Fujifilm Diosynth Biotechnologies formed a strategic alliance with Piramal for antibody drug conjugate production, whereby the two companies will offer contract development and manufacture of antibody drug conjugates. Piramal offers antibody drug conjugate production at its site in Grangemouth, Scotland. In 2012, Fujifilm also expanded 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 HPAPI manufacturing capabilities at its facility in Le Mans, France. The plant expansion was scheduled to be fully operational by the beginning of 2013.
In addition to its HPAPI capacity expansion, Novasep is investing EUR 30 million ($39 million) to build a chromatography plant for the large-volume production of commercial APIs. The plant is being built on Novasep’s existing site in Mourenx, France and is expected to be operational and validated in 2014 . The new plant will contain Varicol continuous chromatography systems with 1200-mm diameter columns operated at up to 70 bars.