CMOs Invest in High-Potency Manufacturing

CDMOs and CMOs offering high-potency manufacturing and related services are expanding in response to increased demand for antibody drug conjugates and other highly potent compounds. Companies are expanding on both the API and finished product side for highly potent compounds.

API expansions
In September 2013, Carbogen Amcis announced a series of investments aimed at enhancing its ADC capabilities. The investments include a $4-million cleanroom clinical-supply facility at its Bubendorf, Switzerland site and on the finished product side, a $950,000-upgrade of the sterile-manufacturing area at its facility in Riom, France. The upgrades at Riom include the implementation of a new vaporized hydrogen peroxide disinfection system and the installation of two new aseptic filling isolators.

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 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. 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. Also, in 2010, SAFC opened a new $30-million high-potency manufacturing facility in Verona, Wisconsin.

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.

Finished product manufacturing

Companies also are expanding high-potency manufacturing on the finished product side. Piramal Healthcare announced in September 2013 that it is investing $11 million at its facility in Morpeth, UK to triple production capacity for hormonal products, including contraceptive pills and hormone-replacement therapies. The expansion will increase the Morpeth site’s production capacity by approximately 2 billion tablets per annum. Work on the new suite, which will house formulation, packaging, coating, and tableting equipment, will begin at the end of 2013, with mechanical completion anticipated within 12 months and full operations expected to begin following a six-month validation period.

This latest investment follows Piramal |Healthcare’s recent $2.5-million investment at its site in Grangemouth, UK, site to upgrade one of its ADC manufacturing suites from clinical phase to commercial grade. The upgrade will give Piramal two commercial-grade ADC suites at the Grangemouth facility while retaining clinical-phase manufacturing capacity in other suites at the site.

In July 2013, Almac’s Clinical Services business unit expanded its service offering for dispensing and bottling solid dosage products by introducing enhanced containment equipment and processes at its EU and US headquarters, respectively in Craigavon, Northern Ireland, and Souderton, Pennsylvania.

In February 2013, Baxter International's BioPharma Solutions business began an approximately 1750-m²capacity 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.

In September 2013, Capsugel’s Dosage Form Solutions business unit announced it will increase it containment capacity at is facility in Ploermel, France to handle hormonal as well as high-potent compounds in softgel manufacturing. Upgrades include a high-precision dosing system and high-speed capsule printing capability.

Other investments

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.