As pharmaceutical companies contend with increased cost pressure and the need to accelerate development timelines, CMOs/CDMOs
play a vital role. The author examines the alliance strategies of contract services providers as a means to build their development
and manufacturing capabilities and facilitate more efficient projectmanagement and technology transfer in the outsourced relationship.
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In the arena of pharmaceutical outsourcing, when speaking of partnerships, the discussion typically focuses on the relationship
between a pharmaceutical/biopharmaceutical company as the sponsor company and a contract services provider. The emphasis is
on the expectations between customer and supplier and the capabilities offered by the contract services provider to the sponsor
company and the ways in which the project may be most effectively managed to meet specified deliverables. And while these
partnerships remain the key focus of pharmaceutical outsourcing, partnerships among contract services providers, ingredient
suppliers, and academia also are becoming a part of the outsourcing paradigm as companies seek to combine capabilities, services,
and products to deliver a more integrated and efficient solution to a sponsor company.
Formulation development andfinished-product manufacturing
In 2012, several CDMOs and CMOs formed partnerships as a means to expand their offerings. For example, Catalent Pharma Solutions
and the CDMO Bend Research partnered to provide integrated solutions for pharmaceutical companies seeking to develop and manufacture
specialized multiparticulate oral controlled-release products. The companies offer combined expertise in formulation development,
and Catalent provides further capabilities in analytical and chemistry, manufacturing and control (CMC) development, solid-state
optimization, and clinical and commercial manufacturing. As part of their agreement, Catalent and Bend Research are developing
joint operations and technology-transfer protocols. The partnership is geared toward complex, multiparticulate controlled-release
products, which traditionally have presented a high scale-up risk when they are transferred to commercial manufacturing sites.
The companies are aligning their scientific expertise and processes to ensure that developments are undertaken using quality-by-design
principles (QbD). Bend also brings laboratory-scale modeling expertise that complements Catalent's expertise in formulation
development and manufacture of controlled-release compounds. Catalent's Winchester, Kentucky facility is a commercial facility
for multiparticulate products.
Earlier in 2012, Catalent Pharma Solutions and BASF formed a broad collaboration and open alliance to provide solutions to
overcome bioavailability challenges of new molecular entities with solubility or permeability challenges (i.e., Biopharmaceutics
Classification System Class II and IV compounds). The alliance combines the expertise of both companies to provide feasibility
studies across multiple technologies, solid-state chemistry, consulting and training, formulation services, excipients, and
optimal dose-form development from scale-up to commercial supply. One specific application for addressing solubility issues
is the use of hot-melt extrusion (HME). BASF has a portfolio of solubilizers and excipients for HME, including its Soluplus
excipient, and Catalent offers HME technologies (OptiMelt). Catalent has made recent investment in its OptiMelt HME and fluid-bed
laboratory- pilot-, and commercial-scale equipment at its Schorndorf, Germany, facility as well as in training and method
development at its facility in Somerset, New Jersey.
On the clinical side, Catalent and the CRO PAREXEL formed an alliance in October 2012 to provide a fully integrated, end-to-end
clinical-trial-material supply-chain solution. This solution is intended to streamline the clinical supply process and reduce
development timelines while improving service quality. In the alliance, PAREXEL brings clinical-trial-management services
and global clinical logistics capabilities, and Catalent brings manufacturing, packaging, and labeling solutions.
To build cross-functional expertise, Catalent Pharma Solutions also launched the Catalent Applied Drug Delivery Institute
to promote innovation, knowledge-sharing, and collaboration between industry leaders, academic experts, customers, and regulators
to enhance understanding of available, emerging, and future drug-delivery technologies. As part of its mission, the Catalent
Applied Drug Delivery Institute, which was launched in 2012, will serve as a link between industry and academia by providing
guidance, counsel, and resources on major issues pertaining to drug development, drug delivery, and formulation. The institute
will develop programs that facilitate mutually beneficial collaborations, increase communication, and shed light on regulatory
issues affecting drug developers and researchers. It also will pursue a multitiered approach of seed funding, strategic counsel,
and educational programs to advance the adoption of emerging technologies.
Other companies also are pursuing collaborations. In October 2012, Bend Research and Dow Chemical formed an exclusive collaboration
to provide science-based spray-dried dispersion (SDD) solutions and select new polymers for poorly soluble oral drugs. Under
the agreement, Dow and Bend Research will work together to provide fully characterized polymers supported by QbD principles
as well as tailor materials to meet the performance needs of specific drugs. In addition, the two companies will develop
and commercialize new materials for SDDs that address technology gaps in manufacturability and delivery to provide greater
drug-product utility and therapeutic performance. Specifically, Dow will provide the excipients hypromellose and hypromellose
acetate succinate as well as cellulosic and noncellulosic polymers.
The collaboration combines Dow's capabilities in materials design, high-throughput screening, and pilot-plant and commercial
scale-up operations with Bend Research's SDD screening, formulation, scale-up, and technology-transfer capabilities. Dow is
supporting the collaboration with several technologies, including high-throughput synthesis with API/polymer screening, laboratory-scale
product development, and structure/property optimization as well as a cGMP market-development plant capable of supporting
clinical development.
In January 2013, Xceleron, a provider of bioanalytical accelerator mass spectrometry (AMS) services for early drug development,
partnered with Crystal Pharmatech, a China-based solid-state research CRO, to offer drug developers early bioavailability
data for producing optimized solid-state forms and formulations. The partnership seeks to apply AMS technology and related
expertise to address pharmacokinetic uncertainty by providing early clinical and solid-state information to provide better
information earlier in drug development about a drug candidate's later-stage readiness. Xceleron applies human microdose and
microtracer techniques using ultra-sensitive AMS to investigate the pharmacokinetics and metabolism of developmental drugs
in Phase 0, Phase I, and Phase II/III clinical trials.
