Tracking the Market for APIs and Intermediates

Highlights from CPhI Worldwide and recent news show fine-chemical companies and CMOs making select investments in capacity and expansion of service offerings.

Siegfried is proceeding with a new 300-m³ production plant in Nantong, China. The company broke ground for the new facility in July 2013. The plant will begin commercial production in mid-2014 and employ a workforce of about 300 by 2015. Siegfried is also proceeding with the construction of a new 100-m³ chemical plant in Zofingen, Switzerland. The new building will replace several older plants at the Zofingen site that no longer comply with efficiency requirements and generate high maintenance expenses. The two plants in Nantong and Zofingen are based on an identical technical concept to facilitate product transfers from a regulatory and technical perspective. A new administration building also will be erected in Zofingen. The new offices will be ready for occupation in the second half of 2015.

Cedarburg Hauser Pharmaceuticals has upgraded its API plant in Grafton, Wisconsin. The upgraded facilities are expected to increase API production by 20–25%. Improvements to the plant include the addition of a 30-ton process chiller, an additional 200-kilowatt backup generator, and an industrial vacuum pump. The company also tripled its filtration capacity through the addition of new, large Aurora filters.

In September 2013, International Chemical Investors Group (ICIG) agreed to acquire Allessa, a manufacturer of fine chemicals, intermediates, and specialty chemicals, headquartered in Frankfurt with production sites in Frankfurt’s vicinity in Fechenheim, Griesheim, and Hoechst. Allessa has more than 890 employees and an internal training center of more than 70 apprentices employed by the company.

The WeylChem Group, ICIG’s non-GMP fine chemicals platform, operates its plants in Griesheim and Hoechst as well, which also used to belong to the former Hoechst conglomerate, and any future cooperation between Allessa and the WeylChem Group, under one ownership, would result in additional synergies.

Earlier in 2013, ICIG agreed to acquire from the Solvay Group Peptisyntha SA, the Brussels-based custom manufacturer of peptides. Upon closing of the deal, expected this fall, Peptisyntha will become a member of ICIG’s CordenPharma platform as its third site offering peptide manufacturing. Although the US sister company Peptisyntha Inc., located in Torrance, California, is not part of the transaction, certain customer relationships will be assumed by Peptisyntha in Brussels.

Johnson Matthey’s Catalysis and Chiral Technologies business unit is expanding its existing specialty ligand manufacturing capability to include commercial-scale manufacturing up to 100 kg. The expansion is largely focused on the Buchwald ligands from the Massachusetts Institute of Technology. The Buchwald ligands are a class of bulky and electron-rich dialkylbiaryl monophosphine ligands, which are used for the in situ generation of active catalysts. These ligands are used for coupling reactions in the manufacture of both pharmaceuticals and specialty chemicals and are more commonly offered at a research scale for use in the laboratory, according to the company. This is the third recent investment by the company, which has made investments at facilities in Taloja, India, last year and has further expansion underway in Royston, United Kingdom.

In February 2013, Albemarle announced that its fine-chemistry services business approved and began construction on another expansion of its Tyrone, Pennsylvania custom manufacturing facility. The $30-million expansion adds new capacity to the site for custom manufacturing projects, but also improves the infrastructure to allow for future expansions. The expansion follows an earlier expansion that began operation in November 2012. The first increment of new capacity will be operational late in the first quarter of 2014.

Earlier this year, 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.

Almac completed its knowledge-transfer partnership with Queens University Belfast, which was intended to develop, improve, and embed bioprocesses to facilitate the delivery of products for its biocatalysis business. The overall partnership aim was to allow technology transfer of fermentation and molecular/microbiology expertise from Queens University to Almac. Almac met the specific partnership objectives by not only sharing a program of work with academics at Queens, but also by attending training courses organized through University College London and embedding key learning back into the company.

Sigma-Aldrich's custom-manufacturing services business unit, SAFC, is expanding two of its manufacturing facilities in the United States: The company is investing in commercial-scale manufacturing capacity for antibody-drug conjugates (ADCs) at its facility in St. Louis, Missouri and is expanding its high-potency API (HPAPI) manufacturing and storage capacity at its facility in Verona, Wisconsin. Additional commercial-scale manufacturing capacity has also been designed to accommodate future growth in demand for ADC production.

Carbogen Amcis is investing $4 million to expand its cleanroom clinical-supply facility at its site in Bubendorf, Switzerland. The Bubendorf facility features a new 100-m² ADC cleanroom suite for the development and production of ADC clinical material under cGMP and contains Grade D and Grade C areas to allow aseptic and safe handling of highly potent material at occupational exposure limit values (OELs) below 1 µg/m³ at 8-hour time weighted average (8h-TWA) In 2012, Carbogen Amcis and ADC Biotechnology (ADC Bio) partnered for ADC development and manufacturing services.

In January 2013, Lonza announced plans to invest CHF 14 million ($15 million) to expand ADC manufacturing capacity at its site in Visp, Switzerland. The expansion of the ADC facility will double the company's existing large-scale manufacturing capacity in Visp. The expansion is expected to be completed in the second quarter of 2014.

In October 2012, Fujifilm Diosynth Biotechnologies formed a strategic alliance with Piramal for ADC production, whereby the two parties will offer contract development and manufacture of ADCs. Piramal offers ADC production at its site in Grangemouth, Scotland. Piramal recently invested $2.5 million at is Grangemouth site to upgrade one of its ADC manufacturing sites from clinical phase to commercial grade. The upgrade gives Piramal two commercial grade ADC suites at the Grangemouth facility while retaining clinical phase manufacturing capacity in other suites on site.