Contract manufacturers expand
Contract API manufacturers offering high-potency manufacturing and related services are expanding in response to increased
demand for ADCs and other highly potent compounds. In January 2013, Lonza announced plans to invest CHF 14 million ($15 million)
to expand ADC manufacturing capacity 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 2012, Carbogen Amcis and ADC Biotechnology (ADC Bio) partnered for ADC development and manufacturing services. ADC Bio
is providing proprietary solid-phase immobilization technologies for conjugation and long-term storage of ADCs, and Carbogen
Amcis is providing small- to large-scale GMP supply and the formulation of ADCs. ADC Bio also recently expanded its facility
in St. Asaph, United Kingdom in northern Wales with the addition of a new technical service laboratory. Commissioned in April
2013, the additional facility at St. Asaph provides ADC screening, process development, and scale-up capabilites.
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. Fujifilm recently announced an expansion of its cGMP manufacturing facilities at its sites in Research Triangle
Park, North Carolina, and Billingham, UK. Novasep announced in 2012 a EUR 3 million ($3.9-million) investment to expand its
highly potent API manufacturing capabilities at its Le Mans, France facility, which is part of the company's strategy to be
positioned in the ADCs.
Earlier this year, Catalent Pharma Solutions acquired an exclusive license to market Redwood Bioscience's proprietary SMARTag
protein-chemical engineering technology used in site-specific protein modification and linker chemistry for ADCs. Catalent
will have the exclusive right to sublicense the SMARTagtechnology and will work with Redwood to comarket the technology and
support sublicense programs. As part of the collaboration, Catalent will also take a minority equity stake in Redwood, which
may increase over time up to a potential acquisition.
Companies also are expanding on the finished product side. In February 2013, Baxter International's BioPharma Solutions business
began an approximately 1750-m2 capacity expansion at the company's fill–finish cytotoxic contract manufacturing facility in Halle (Westfalen), Germany.
This expansion follows previous expansions in Halle in 2007 and 2011. In April 2013, Goodwin Technology and Coldstream Laboratories
agreed to develop and manufacture high-potency, highly cytotoxic materials, such as small molecules, protein toxins, cytotoxic
ADCs, and other bioconjugates. GBI will use Coldstream's cGMP platform of services, including analytical testing, formulation,
liquid or lyophilized fill–finish, storage and shipment of manufactured highly-potent bioconjugates.
In May 2013, Penn Pharma successfully completed the first batch of coated tablets at its new contained manufacturing facility
in South Wales, UK. The facility is designed for the clinical and commercial manufacture of tablets and capsules. In November
2011, Metrics began offering neat API capsule-filling at its potent and cytotoxic facility in Greenville, North Carolina.
The company secured a Capsugel Xcelodose system, a powder microdoser and automated encapsulator that places API directly into
capsules with a high level of accuracy. Metrics also installed a custom-built isolation system for the equipment. The company
offers dedicated and segregated potent and cytotoxic cGMP manufacturing for Phase I–III projects. It opened a new potent and
cytotoxic drug-development facility in 2009 as part of an expansion of the company's Greenville facility.
Other companies are positioned in both API and finished product manufacturing for highly potent compounds. For example, CordenParma
has facilities in Plankstadt (Germany), Latina (Italy), and Boulder (Colorado) for manufacturing highly potent APIs and drug
products. Aesica, based in Newcastle-Upon-Tyne, UK, opened a new high-potency manufacturing facility in Queenborough for formulated
products in late 2011. The company later upgraded its UK-based API manufacturing facilities in Cramlington and Queenborough
to manufacture high-potency APIs.
Patricia Van Arnum is a executive editor of Pharmaceutical Technology, 485 Route One South, Bldg F, First Floor, Iselin, NJ 08830 tel. 732.346.3072, email@example.com
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