The Road Ahead for Contract Service Excellence

Leading contract service organizations discuss operations and strategies driving success.

By Steven Kuehn, Editor-in-Chief

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For biopharmaceuticals it’s well established that the process is the product, but it might be fair to say that for CMOs — regardless of small or large molecule production — process is their true product, and strategically the means in which these companies excel and differentiate themselves by creating and sustaining the value (and hence profitable sales) for their services. “In regards to DSM’s high-value offerings,” says Nowak, “we were the first Safebridge Certified cytotoxics sterile production site globally. We also have the largest lyophilization capacity in the North American CMO industry category.”

One notable challenge within Pharma, notes Wright, is the difficulty of getting certain complex proteins to express accurately and with high purity. Low yields, protein degradation, aggregation, and timely purification processes are common frustrations with protein expression in microbial systems. “Through its patented and novel expression technology, Corynex, Ajinomoto Althea can provide the industry a solution to many of these problems, says Wright. “Using the bacterium strand Corynebacterium glutamicum, Corynex is able to secrete fully active and folded proteins, with high initial purity, directly into the cell medium. This eliminates many of the costly and time-consuming purification steps required with traditional expression systems.”

Last October, DSM Pharmaceutical Products officially announced opening of its new cGMP facility for biopharmaceutical contract manufacturing in Brisbane, Australia. The Brisbane facility serves DSM’s blueprint for its future. Not only does the facility field current industry standard technologies, DSM has integrated its own innovative and proprietary technologies including XD process technology and its RHOBUST direct capture downstream technology that optimizes bioprocess manufacturing processes, driving down cost and processing times. DSM’s proprietary techniques and technologies, says the company, can cut out several processing steps. According to DSM, its XD cell culture technology achieves 5 to 25 times higher product output than standard processes, producing very high cell densities while retaining high cell viability and consistent quality.

Catalent continues to make significant investment into drug delivery technologies, capabilities, as well, maintaining the presence necessary to help Pharma’s innovators bring better products to market. “In fact,” says Berger, “around $1 billion has been invested globally over the last five years. Catalent’s strategy has, for some time, been to build deep expertise in those segments in which we operate, and we have invested on a major scale in quality people and processes to ensure reliable global supply.” Speaking of reliable supply, last summer Catalent opened its new biomanufacturing facility in Madison, Wis., that features state-of-the-art disposable technology and an efficient process layout that supports sterility and throughput. “We don’t compromise on quality. We maintain a single Quality Management System and our inspection outcomes are three times better than the industry average, and we are approved to ship to over 80 countries,” says Berger.

Catalent counts among its value leaders a number of innovative offerings including advanced SMARTag ADC technology in partnership with Redwood BioSciences, an advanced oral dose form development and supply including OptiMelt hot melt extrusion technology in Europe, expert development to final dose scale up and manufacturing in the U.S., as well as OptiDose tableting technologies for sophisticated drug delivery profiles including combination therapies, complex timed delivery and pulsatile release. Catalent says it also offers oral delivery of macromolecules with its new industry-leading technologies OptiGel Bio and Zydis Bio.

Irvine Pharmaceutical Services says supporting its value to customers is the company’s ability to accelerate its processes to meet customer’s needs. “We believe our manufacturing turnaround time, typically less than 25 days, is among the best in the CMO space,” says Ruby. “We can accomplish this task because we have invested in experienced operators and talented scientists.”

A key area in which Catalent is making rapid advancement in data and information sharing is with its global Clinical Trial Supply business focusing on digital solutions for advanced Clinical Supply Management, inventory and supply transparency and customer data access. Irvine is currently in the process of moving its IT infrastructure to a secure and compliant cloud-based system. “With well established systems and contingency plans,” says Ruby, this update in infrastructure allows Irvine to have even stronger data security and system reliability. We are also implementing secure, Web-based client access to real time data and project status updates.”

With broad geographic operations, Patheon’s systems landscape is complex, which can make collaboration and information sharing tough. “As a global CMO,” explains Charlie Lickfold, Vice President and head of IT, “We have specific challenges that we use information technology to help resolve. In an effort to utilize technology to improve communication processes with our customers, Patheon established and utilizes a customer collaboration strategy and platform. This platform provides the needed framework for information exchange, which enables us to exchange and share information electronically with our customers.” This electronic collaboration solution, says Patheon, allows the company to expedite supply chain processes and simplify the means of information exchange by providing a single integration point for all of Patheon’s sites to its customers.

“Innovation comes from many sources,” explains Catalent’s Berger, “and through effective collaboration between those engaged in the improvement of medicines, improved clinical outcomes can be found.” Berger says that is why his company established the Catalent Applied Drug Delivery Institute with the aim of “harnessing the knowledge of the world’s leading experts; partnering with pharmaceutical companies; facilitating mutually beneficial collaborations; and sponsoring, educating and counseling to advance the adoption of emerging technologies.”



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