Building Technology Positions in API Manufacturing - Pharmaceutical Technology

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Building Technology Positions in API Manufacturing
As contract manufacturers and fine-chemical suppliers gather for CPhI/ICSE, effective strategies for technology differentiation are key in an increasingly competitive environment.


Pharmaceutical Technology
Volume 35, pp. s10-s14

A changing landscape

As companies enhance their technology positions and invest, others are restructuring, and some are emerging as new players in contract biologics manufacturing. In March 2011, International Chemical Investors Group acquired the pharmaceutical intermediates business of Genzyme and integrated it into its pharmaceutical subsidiary Corden Pharma as Corden Pharma Switzerland. Corden Pharma Switzerland is a supplier of lipids, peptides, carbohydrates, amino acid derivatives, pseudoprolines, and small molecules.

In April 2011, Fujifilm Diosynth Biotechnologies, a provider of contract biologics development and manufacturing services, began operations following the completion of its acquisition of the Merck Biomanufacturing Network. The acquisition included facilities in Billingham, United Kingdom, and Research Triangle Park, North Carolina. In June 2011, Fujifilm Diosynth Biotechnologies and Mitsubishi formed a partnership for contract biopharmaceutical manufacturing under which Mitsubishi took a 20% equity stake in Fujifilm Diosynth Biotechnologies.

In June 2011, Fujifilm Diosynth Biotechnologies expanded its mammalian cell-culture capacity by adding a 1000-L single-use bioreactor from the biomanufacturing company Xcellerex to its Research Triangle Park, North Carolina, plant. The expansion is slated to be validated and operational by the first quarter of 2012. The project is the continuation of a cell-culture capacity expansion by Fujifilm Diosynth Biotechnologies.

In February 2011, the materials manufacturer Nitto Denko acquired Avecia Biotechnology, a provider of therapeutic nucleic-acid manufacturing and development services. Avecia provides cGMP manufacturing services, development of analytical methods, process validation, stability studies, quality control, and regulatory support.

Nitto Denko is positioned in nucleic-acid drug technology with its wholly owned subsidiary Nitto Denko Technical, which is based in Oceanside, California.

In May 2011, the private-equity firm Ridgemont Equity Partners acquired a majority stake in Gallus Biopharmaceuticals, a contract biologics manufacturer based in St. Louis. The investment by Ridgemont allows Gallus to acquire a biologics manufacturing facility in Berkeley, Missouri, from Centocor Biologics, a part of Johnson & Johnson. The plant manufactures two Centocor products, Remicade (infliximab) and Stelara (ustekinumab). Ridgemont's investment also will expand the facility's manufacturing capabilities, including by building a clinical-services suite and expanding the existing development laboratory. Gallus plans to make an initial capital investment of $20 million to expand the facility, according to a May 18, 2011, press release by the governor's office in Missouri. Also, in May, Gallus formed a collaboration with the biomanufacturing equipment provider Xcellerex under which Gallus will acquire several Xcellerex bioproduction systems.

Granules India, a vertically integrated pharmaceutical manufacturer, and Ajinomoto OmniChem, a producer of fine chemicals, recently formed a joint venture to offer APIs and intermediates. The new company, Granules–OmniChem is equally owned by both companies and will operate a new production facility in Vishakhapatnam, Andhra Pradesh, India. Construction of the facility will begin by November 2011 and is expected to be completed by late 2012. The facility will begin production by January 2013. The company will initially focus on high-value, low-volume APIs and intermediates for existing customers and will custom manufacture new chemical entities in the future.

In August 2011, CABB, a provider of chemical building blocks, fine and specialty chemicals, and custom-manufacturing services, completed the acquisition of the fine-chemicals company KemFine Group Oy. CABB is a supplier of chemical building blocks based on chlorine and acetic acid. In 2010, CABB employed 750 people and had revenue of EUR 311 million ($447 million). KemFine Group Oy, headquartered in Helsinki, operated a production facility in Kokkola, Finland with approximately 190 employees. It had 2010 sales of EUR 81 million ($116 million).

Carbogen Amcis announced a restructuring in February 2011 for its Swiss operations in Bubendorf, Aarau, and Hunzenschwil. The Aarau site will focus more strongly on development, and the Hunzenschwil site on the pilot production of early-phase projects. Large-volume production and the manufacturing of highly active agents will continue at the Bubendorf site. The restructuring involves a headcount reduction of 60 employees.


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