Mid-Sized Chemical Players Target Specialized Technology

Informex, ORLANDO - Facing growing competition from offshore suppliers, several mid-sized custom manufacturers announced expansion plans in specialized technologies at Informex this week.

Ampac Fine Chemicals expands SMB unit

Ampac Fine Chemicals (Rancho Cordova, CA, www.apfc.com) is expanding its capabilities in simulated moving bed (SMB) chromatography by adding a sixth unit that is scheduled to be operational in March. The new 5 x 1000 mm unit is the largest SMB unit in North America, says Olivier Dapremont, chromatography specialist, business development at Ampac Fine Chemicals (AFC). Ampac Fine Chemicals also has 8 x 200 mm and 6 x 800 mm SMB units. Its SMB units can accommodate throughput of up to 50 to 100 metric tons.

"SMB is commonly used for enantiomer separation, but it can be also used for impurity removal and other binary-like separations," said Dapremont.  

SMB is one core competency of Ampac Fine Chemicals, which also specializes in energetic chemistry (i.e., azide chemistry), high-potency active pharmaceutical ingredient (API) manufacture, and high-containment manufacture, explains Aslam Malik, president of Ampac Fine Chemicals. Malik took the helm of Ampac Fine Chemicals in late 2005 following the acquisition of Aerojet Fine Chemicals by American Pacific Corporation (Las Vegas, NV, www.american-pacific-corp.com), a specialty chemical company supplying the aerospace, automotive safety and explosives industries. Ampac renamed the former fine chemicals business of Aerojet as Ampac Fine Chemicals, which now operates as a wholly owned subsidiary of American Pacific Corporation.

Ampac Fine Chemicals is keeping to its mission of supplying advanced intermediates and APIs to the pharmaceutical industry, which constitutes 100 percent of its customer base, explains Malik. Over the past 15 months, Ampac Fine Chemicals has spent almost $40 million on capacity expansions, which include a new 8,500-gallon cGMP production line and a new 4-square-meter filter dryer at its facilities in Rancho Cordova, CA. Overall, Ampac has 41,500 gallons of GMP reactor capacity.

CSS launches new radiolabeling service

CSS (Craigavon, Ireland, www.almac-sciences.com) is launching new carbon-14 labeling services. CSS will provide radiolabelling services for the synthesis of metabolites, intermediates and active pharmaceutical ingredients (APIs). The company will also offer GMP synthesis of carbon-14 labeled APIs.

The new radiolabelling service is part of CSS's transformation from a traditional contract chemistry provider to one that offers specialized products and services in chiral chemistry, radiolabeling, high-potency API manufacturing, and peptide manufacturing.

 "We have sought to provide advantages for our customers by providing individually differentiated and connected services," says David Moody, vice president of commercial operations at CSS.

Over the past three years, CSS has invested over $40 million in upgrading its facilities at Craigavon, Ireland. The facility has small-molecule kilo-lab suites, two GMP production lines in the 50 to 600 liter range and potent and cytotoxic manufacturing suites from 1-600 liter scale. "Through 2005, CSS continued to invest in high-potency substances (cytotoxic manufacture) and GMP peptide manufacturing. We are now investing in further GMP capability to manufacture peptides in the gram to multi-ton scale," says Moody.

CSS broadened its portfolio in peptide manufacturing in 2004 when it acquired a controlling interest in Albachem, a Scottish biotechnology company based near Edinburgh, founded by Professor Robert Ramage, an expert in the chemical synthesis and purification of proteins and peptides.

A specialized area of expertise for CSS is being able to produce long-chain peptides. "Advanced, solid-phase synthesis, purification, and folding techniques now allow us to supply proteins up to 170 amino acids in length," says Moody. The company also manufactures shorter-chain peptides, offering more than 100 peptides per month of less than 40 amino acids in length.

CSS also is launching a range of variously labeled chemokines (peptides of 70 amino acids in length) in milligram to gram quantities. "These are particularly important in cell-receptor drug binding studies," says Moody.

Ferro Pfansthiel expands high-potency API manufacturing

Ferro Pfanstiehl (Waukegan, IL, www.ferro.com) , part of the pharmaceuticals and fine chemicals division of Ferro Corporation, has commissioned a new validated Class IV containment facility specifically designed and engineered for low-volume production of high-potency active pharmaceutical ingredients (HPAI) and early-phase small molecule chemical entities. The two-floor, 2,000-square foot facility addition is the first phase of multi-phase Tier 1 provider capital build-out program.

Ferro Pfanstiehl also is nearing completion of a CGMP supercritical fluid-based particle size engineering pilot lab, which will bring additional CGMP capabilities and expertise in particle sizing, purification and formulation applications. It is expected to be operational by the second quarter of 2006.

Excelsyn launches a three-pronged approach

Meanwhile, Excelsyn (Newcastle, UK, www.excelsyn.com) is diversifying its business model and emphasized its three-pronged approach in serving the pharma industry at Informex this week. Founded by Ian Shott, a former executive with Imperial Chemical Industries, Zeneca PLC, Lonza (Basel, Switzerland, www.lonza.com), and Rhodia-ChiRex, the company has a management consultancy business, an engineering technology consultancy, and a molecular development facility that offers contract R&D to small-scale manufacture of pharma ingredients.

Shott started his own management consultancy in 2003 but began transforming the business with key acquisitions in 2004. This included the acquisition of the former fine chemicals site of Great Lakes Corporation in Holywell, UK, which serves as the basis for its molecular development services today, and the acquisition of WH Promation, which serves as the basis of Excelsyn's engineering technology capabilities.

"Our molecular development facility offers kilo-lab (up to 50 kg) and pilot-plant capabilities (reactor volumes up to 4,500 liters) as well as GMP production capacity (up to ton quantities)," says Gareth Jenkins, business development manager, Excelsyn Molecular Development. 

The engineering technology firm, headed by Kenny Gilmour, managing director, specializes in hygienic and sterile processing systems design, construction, operational commissioning, validation and maintenance. "We target small to mid-sized companies, including biotech companies, as well as key projects for big pharma," says Gilmour.

The management consulting piece of Excelsyn is headed by Mark Nugent, managing director of Excelsyn Management Consulting. It has eight associate consultants and also forms alliances with other specialized consultants in fine chemicals and pharmaceutical manufacturing. In 2005, it formed such alliances with Jan Ramakers Fine Chemicals Consulting Group, which provides benchmarking and market research in fine chemicals and DACG, an IT consultancy specializing in enterprise resource planning and information technology system implementation.