Several companies have announced overall manufacturing capacity additions. For example, Albemarle is expanding its manufacturing
facility in Tyrone, Pennsylvania. The $30-million expansion builds on an earlier expansion that began operations in November
2012, which will result in an eventual 40% increase in reactor capacity for the company’s custom-manufacturing business. The
first increment of new capacity will be operational late in the first
quarter of 2014.
In February 2013, PharmaZell added an additional manufacturing site to its European manufacturing network. The company acquired
a manufacturing site in Liestal, Switzerland previously operated by AbbVie (formerly Abbott). Abbott’s pharmaceutical business
was spun off in a separate company,
AbbVie, in January 2013. The Liestal site consists of multipurpose manufacturing equipment with 150 m3 of reactor volume with
drying and milling capacity, packaging cleanrooms, a pilot plant, quality-control laboratories, and warehouses for manufacturing
small-molecule, large-volume APIs.
In 2012, Almac expanded its API manufacturing facility at its European headquarters in Craigavon, United Kingdom, with a scheduled
completion for the end of 2012. The upgrade included installation of two 1000-L reactors and a pressure-filter dryer, which
allows production of GMP APIs up to 150-kg batches.
In September 2012, Cambridge Major Laboratories (CML) reported that it is expanding its large-scale API manufacturing facility
in Germantown, Wisconsin. The expansion comes three years after commissioning the new site. The expansion includes additional
reactor capacity and isolation equipment as well as additional investments in engineering controls. Also, in 2012, Cedarburg
Hauser Pharmaceuticals expanded its capacity at its Wisconsin-based API manufacturing plant and made additional upgrades for
improving safety and GMP systems.
Other companies are making targeted investment in select manufacturing activities. In 2012, Dr. Reddy’s Custom Pharmaceutical
Services expanded its activated mPEG manufacturing capabilities at is facility in Mirfield, United Kingdom. SAFC, part of
Sigma-Aldrich, is expanding its operations in Scotland by investing in the development of a new powder-manufacturing facility
at its Irvine site. SAFC’s new facility in Irvine is its second powder manufacturing facility, which will support SAFC’s risk-
management program, which provides an internal back-up supplier for its customers. The new facility will be used to serve
customers across Europe.
Almac and DSM Pharmaceutical Products recently reported the successful transfer of enzymes for enzyme screening, process development
and scale-up as part of the companies’ agreement in biocatalysis, which was announced in October 2012. The agreement grants
both companies 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 February 2013, DSM Pharmaceutical Products signed an agreement with Chemtrix, a supplier of flow-chemistry equipment and
services, for providing equipment, development and manufacturing services to the pharmaceutical industry. Chemtrix specializes
in ready-to-use laboratory and kilo-scale microreactors as well as reactor and process design for industrial reactors. DSM
provides drug-synthesis route development, scale-up, and implementation of
continuous-flow processes for manufacturing. DSM has FDA approval for using microreactors for making a pharmaceutical product
at commercial scale under cGMP at its facility in Linz, Austria, where its dedicated commercial-scale installation is located.
The DSM–Chemtrix collaboration will initially offer an industrial flow process-
development package for customized scalable flow-chemistry solutions. The package covers all phases of process design, scanning
chemistries, chemistry development, route scouting, equipment design, and scale-up for fully continuous or integrated processes.
Ajinomoto plans to invest approximately JPY 1.3 billion ($13.9 million) to double production capacity for amino acids for
use in pharmaceuticals and foods at its subsidiary Shanghai Ajinomoto Amino Acid in Shanghai. The expansion is scheduled to
come on line in October 2013. Ajinomoto estimates the current global market for amino acids for pharmaceuticals and foods
at 30,000 tons, and with growth in emerging markets, expects demand to rise to 45,000 tons by 2020.
Several fine-chemical producers and contract API producers also recently announced activity in support of finished product
manufacturing. For example, earlier this year, Ajinomoto agreed to acquire Althea Technologies, a San Diego-based contract
provider of fill–finish services. Aesica and the CDMO EmulTech are partnering on the commercial development of ET4ME, an emulsion
technology for product formulation. ET4ME is a microencapsulation technology that uses a microfluidic process to create a
measurable microparticulate suspension. The technology can be used for small molecules and biologics.
Cambrex agreed to contract manufacture Dow Chemical’s hydroxypropyl methylcellulose acetate succinate, an excipient provided
by Dow as part of a solubilization partnership that Dow and Bend Research formed in 2012 under which Dow is commercially supplying
solubility-enabling excipients. Cambrex has begun construction of the new facility at Cambrex’s site in Karlskoga Sweden with
commercial product availability set for year end 2013. In another development, ScinoPharm and Foresee Pharmaceuticals agreed
to form a joint venture to develop a series of peptide injectable drugs, with the first being a leuprolide injectable drug
product, by which leuprolide will be formulated in a proprietary controlled-release drug delivery system originally developed
by Foresee and transferred to the joint venture. ScinoPharm is investing $3.6 million for a minority ownership in the new