The investment activity of CDMOs and CMOs reveals the broader business and technical trends of the pharmaceutical industry.
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The author examines recent expansion activity. Some key areas of investment are technologies for bioavailability/solubilization
enhancement, formulation and manufacture of high-potency drugs, and modified-release applications.
Contract service providers offering formulation-development, drug-delivery, and manufacturing services are an important part
of the value chain for pharmaceutical companies. Recent expansion activity of CDMOs and CMOs reflect the business and technical
trends in the pharmaceutical industry as a whole. Key areas of investment include capabilities to support bioavailability
enhancement, modified-release applications, parenteral-drug manufacturing, and high-potency drugs.
Building the toolbox
Thus far in 2013, Catalent Pharma Solutions has made several moves to strengthen its position globally as well as to strengthen
its toolbox. Earlier this year, the company formed two joint ventures in China, one for its softgel technologies business
and one for its clinical-supply-solutions business. In softgels, Catalent agreed to acquire, pending regulatory approvals,
a majority share in the Haining-based and privately held Zhejiang Jiang Yuan Tang Biotechnology, which produces nutritional
softgel products for the Chinese and Asia Pacific markets. In a separate move, Catalent, and ShangPharma Corp., formed a new
joint venture, which includes a new 31,000-ft2 facility in Shanghai. The facility, currently under construction, will offer capabilities in clinical-trial supplies, including
comparator sourcing, primary and secondary packaging and labeling, storage, and distribution. The facility is scheduled to
open later this year.
On an organizational basis, in July 2013, Catalent created a new business unit, Advanced Delivery Technologies, which aligns
the company’s existing modified-release and
medication-delivery businesses. The company’s business units now include Catalent Softgel Technologies, Advanced Delivery
Technologies, and Development and Clinical Services. Additionally, Catalent is investing $35 million to expand its controlled-release
manufacturing facility in Winchester, Kentucky. The 100,000-ft2 facility is expanding by almost 80,000-ft2. Catalent expects the expansion to be completed by October 2014.
Earlier this year, Almac’s Clinical Services business unit expanded its services for dispensing and bottling solid dosage
products with new enhanced containment equipment and processes at its EU and US headquarters, respectively in Craigavon, the
United Kingdom and Souderton, Pennsylvania. Additionally, Almac is expanding its commercial-manufacturing capacity and recently
added a new non-GMP drug formulation-development facility in Craigavon for a total investment of £13.7million ($21 million).
The commercial expansion adds blending equipment and an automated packing and integrated cartoning line for high-volume bulk
commercial manufacturing scheduled to begin in November 2013. Almac also launched US commercial packaging services following
a successful FDA inspection and new client partnership for its facility in Audubon, Pennsylvania. The facility offers flexible
packaging from primary packaging of solid oral dosage forms to customized secondary labeling and packaging of sterile biopharmaceutical
Metrics launched a new proprietary technology (SUBA) that enhances the bioavailability of poorly water-soluble drugs. The
technology was successfully used by the parent company of Metrics, Mayne Pharma, which acquired Metrics in 2012. Mayne Pharma
has applied SUBA technology to improve the bioavailability of the antifungal drug itraconazole. Metrics also introduced proprietary
taste-masking technology, Cleantaste. The company also launched capabilities to produce nonsterile liquids, creams, and gels.
The company’s cream suite can manufacture two- and three-phase suspensions and emulsions, including pastes, creams, lotions,
and gels. Its two filling lines, which are modular and can be assembled according to product format, and its liquid-processing
equipment can produce batch sizes ranging from 250 kg to 2000 kg. Metrics also introduced proprietary pellet technologies
for controlled-release applications. Mayne Pharma has successfully applied the pellet technology to a number of proprietary
pharmaceuticals with modified-release profiles, including Eryc (delayed-release erythromycin), Doryx (delayed-release doxycycline),
Kadian (extended-release morphine), Astrix (delayed-release low-dose aspirin), and pulsed-release diltiazem.
The CDMO UPM Pharmaceuticals acquired a former Pfizer 500,000-ft2 commercial-manufacturing facility in Bristol, Tennessee. The acquisition provides UPM with large-scale commercial capabilities
for manufacturing and packaging of solid oral dosage tablets and capsules as well as for semisolid manufacturing of creams
and ointments. The facility further provides for technology-transfer support, pilot-plant scale-up capabilities, analytical
and microbial testing, and dedicated suites for potent compounds. As part of the purchase, UPM will continue to manufacture
Pfizer’s current portfolio of products within the facility for two years. Pfizer gained the facility with its acquisition
of King Pharmaceuticals in 2012. King Pharmaceuticals was founded by UPM’s current Chairman and CEO John Gregory. In addition,
in May 2013, UPM increased its capabilities for API-in-capsule dosage forms with the addition of a powder-microdosing system
(Xcelodose, Capsugel). The company also added to its analytical capabilities with the addition of a differential scanning
calorimeter and a thermogravimetric analyzer.