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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Far from the monoplant model is Irvine Pharmaceutical Services Inc. and its subsidiary Avrio Biopharma. The 26-year CMO veteran prides itself on being able to take on projects with unique challenges and needs and fast turnaround times. “We are seeing an increase in requests for nano-particle formulations and suspensions for both marketed products and NCEs,” offers Irvine’s Kale Ruby, senior vice president, operations. “We believe that the broad experience of our formulation and manufacturing groups will aid our clients in the challenges associated with new formulation technologies.”

ON INNOVATION
In a piece published by Results healthcare, “Pharmaceutical Manufacturing trends and investment opportunities in 2013,” authored by Dr. Sarah Houlton, prominent Pharma journalist and Kevin Bottomley, Results healthcare’s managing director, Contract Pharma’s agility and technical acumen is an acknowledged fact: “Many CMOs have developed significant chemical synthesis capabilities and are now able to take on complex chemistries. They can also design new and improved routes to make API molecules more cheaply and efficiently. If a better, more cost effective synthetic route can be devised, particularly if the IP is protected in some way, this can enable CMOs to gain advantages in the manufacture and supply of individual APIs to secondary manufacturers.”

Whether through research, survey or anecdotal evidence, there is plenty of data supporting Holton and Bottomley’s assertion that CMOs are the engines revving development and manufacturing innovation, something backed up by the CMOs queried for this look across the CMO fleet. “Customers come to DSM Pharmaceuticals for support of complex drug product development,” says DSM’s Nowak. “As a traditional contract manufacturing organization DSM must continually innovate its processes and technologies to stay ahead of the ever-changing and complex requests made by our customers. Pharma companies will continue to increase their demands for flexible, reputable and high-quality CMO partners. Many Pharma companies will co-invest to build out particular technologies, processes and capacity. Some CMOs will begin to assume more risk during the product-development phases, and in turn, will expect to receive milestone payments.”

Elliott Berger, Catalent’s Vice President, Global Marketing & Strategy explains that with a high proportion of drugs in development suffering from poor solubility and/or permeability, customers are increasingly looking for partners to help improve the bioavailability of their development products or to optimize the treatment to patients. “Formulations vary significantly, so it is helpful that Catalent is able to offer a variety of technologies that improve the effectiveness of pharmaceutical products for certain patient groups; for example, those who have difficulty swallowing, to alter the release profile of an API into the bloodstream, perhaps making the dose more convenient or minimizing side-effects — that is, to delay or pulse release, or to combine multiple APIs in one convenient dose form — to prevent abuse or redirection, and ultimately to make better treatments that are clearly differentiated from a patient and payer perspective.”

Vetter’s Soelkner finds that the ability to innovate in response to a customer’s technical roadblocks is really the stock-in-trade of successful CMOs. “As a strategic partner for (bio-) pharmaceutical companies in today’s complex environment, we are continually being challenged to develop new services and products in order to support them in the best possible way.” He explains that state-of-the-art technology, while critical to the process, is not the only requirement that it takes to be successful. “This is particularly true when considering the ever-growing share of more and more complex molecules and sensitive drug substances. Experience-based solutions that conclude in innovative and product-specific approaches in development and commercial manufacturing are equally important and are playing an ever-increasing role in realizing successful outcomes.”

Ajinomoto Althea’s Wright notes that innovation in Pharma is characteristically different than other industries. “While many other industries are made up of individual innovations that can be differentiated, the Pharma industry as a whole represents innovation. The mere nature of the industry is comprised of continuous advances that strive to push the frontiers of medicine and bring life-saving medicines to those in need. In an industry as complex as pharmaceuticals and life sciences, there are many challenges to overcome, and a single solution to a challenge helps push the entire industry forward.”

As a whole, the industry is now less able to sustain the research and development budgets of years gone by, says Catalent’s Berger. “If innovation were ever proportional to R&D activity, then it would naturally have declined unless new models of research and development were found.

Innovation is becoming more challenging for pharma because of the more difficult molecules coming through their pipelines — often for rare disease states and specialty treatments. “We believe innovation is ramping up of late, taking advantage of better economic and funding environments,” says Berger. “We partner with customers in helping to drive this innovation with advanced drug delivery technologies that help take these molecules from ‘desired drug delivery profiles’ into ‘successful treatments,’ facilitating a less difficult road from lab to patient.”

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