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PTSM: Pharmaceutical Technology Sourcing and Management
Buoyed by increased demand for pharmaceutical outsourcing services, Ricerca Biosciences proceeds with an expansion plan.
Ricerca Biosciences LLC (Concord, Ohio), a contract drug-development company, is moving forward with a steady expansion program by adding staffing and broadening its biological and pharmaceutical chemical development capabilities.
Ricerca focuses on providing drug-development services of small molecules from discovery through commercial manufacture using both biological and chemical capabilities. Its services include lead optimization, analytical and process chemistry, services for toxicology and pharmacology, radiosynthesis, manufacturing of active pharmaceutical ingredients (APIs), and regulatory support. Its API production facilities in Concord, Ohio, include kilo laboratories operating at the 50-L scale and plant-production systems with capacities of between 200–2000 L in scale. Ricerca works with large pharmaceutical companies as well as emerging or start-up companies that often need a broader scope of services to support their drug development.
In 2007, the company completed a financial restructuring that includes new equity and term facilities of more than $75 million. That refinancing is allowing the company to implement a three-year business plan that includes $25 million of new investment to expand chemistry and biological laboratories at its 45-acre site in Concord.
During the past year, in its chemistry operation, the company added and qualified isolation and drying suites to allow for more efficient utilization of pilot-plant equipment. In addition, the company expanded its nuclear magnetic resonance (NMR) capacity through the acquisition and qualification of a Bruker 400 MHz Avance III NMR (fitted with an autosampler and a low temperature probe to –100 degrees C with capability to run two- and three-dimensional spectra).
In its biological services (toxicology, bioanalytical, drug metabolism and pharmacokinetics), the company has made significant investment in a building expansion to augment its toxicology services, high-end equipment (such as liquid chromatographic–mass spectrometric equipment, API 4000 LC–MS–MS, and flow cytometry) and increased staff numbers by nearly 50% during 2007 and 2008.
Ricerca offers integrated resources to an investigational new drug (IND) program. Its services support advancing hit molecules to development candidates for an IND application. These capabilities include medicinal chemistry services for evaluating, validating and optimizing active compounds for a discovery program, lead-chemistry optimization, custom-focused libraries synthesis, synthesis to establish structure activity relationships, chemistry and synthetic route development, and synthesis of reference compounds, scaffolds, building blocks, and starting materials. It also provides drug-ability assessment, metabolite identification, and impurity studies as well as toxicology and pharmacology services, which include in vitro absorption distribution, metabolism, elimination, and toxicity (ADMET) testing and in vivo biological testing, including animal-efficacy models. To support IND candidates through clinical development, Ricerca provides process optimization, scale-up, manufacturing under good manufacturing practices (GMPs), and bioanalytical testing.
To support these programs, Ricerca has a strategic alliance with Latitude Pharmaceuticals (San Diego), a formulation company with expertise and experience in preclinical formulation development. “This alliance has increased our ability to offer formulation capability for drug product to complement our expertise with drug substance API manufacture,” says Jack Jiang, PhD and vice-president of drug discovery at Ricerca.
In addition, Ricerca has a close working relationship with a Chinese partner, Bicoll (Shanghai), which allows the company to offer low-cost full-time equivalent medicinal chemists for the synthesis of custom intermediates for early-stage API synthesis. “Such work is performed in collaboration and under the direction of our US-based medicinal chemists,” explains Jiang. Ricerca also outsources late-stage custom intermediates to TCL Research in Ranipet, Tamil Nadu, India, to enable further cost-savings.
Overall, Ricerca reports good growth for outsourcing on an industry level and for the company specifically. “Pharmaceutical outsourcing is continuing to grow, and demand for service is at an all-time-high,” says R. Ian Lennox, chairman and CEO. “Market performance in 2008 clearly outstrips 2007, and we have every expectation that demand will again increase in 2009.”