Companies also have made investments to increase capacity for high-potency forms. 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. Goodwin 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. Penn invested £14 million ($21 million) for the new 15,000-ft2 facility, which includes the capability
to handle potent compounds. In July 2013, the company announced an additional £3-million investment ($4.6 million).
Other companies are making moves as well. Bend Research expanded its GMP analytical capabilities with the addition of onsite
stability storage and additional GMP testing capabilities for clinical-trial material supply. The company recently added instrumentation
to its existing suite of GMP-qualified analytical equipment, including a differential scanning calorimeter and particle-size
analyzer. In May 2013, Halo Pharma took a minority ownership position in and established a formal collaboration with the
drug-formulation and development company Altus Formulation. Capsugel launched its new LIPIDEX technology platform that integrates
its lipid, liquid, and semisolid fill technologies, product-development capabilites, and commercial-manufacturing infrastructure.
The platform is part of Capsugel’s Dosage Form Solutions business unit.
Earlier this year, Azaya Therapeutics, an oncology company developing cancer treatments through its nanotechnology platform,
launched Parexo Labs, a CDMO providing contract chemical testing and liposomal manufacturing services. In April 2013, the
fine-chemicals company Ajinomoto acquired the CDMO Althea Technologies, which offers protein formulation and fill-finish services
as well as contract biologics manufacturing. Aptuit launched a translational strategy (i.e., Complementary Vision) for chemistry,
manufacturing and control (CMC) services. It is an approach that encompasses all the services that precede and follow CMC
in the target product profile: API development and manufacture; qualitative/quantitative chemical, physical and biopharmaceutical
characterization of actives and dosage forms; dosage-form design; development and manufacturing for preclinical and clinical
dosing; and the development, manufacturing and testing of inhaled products such as dry powder inhalers.