October 1, 2014 (Vol. 34, No. 17)

Cytovance Views Clear Communication Skills as well as Technical Expertise as Keys to Success

The ability and willingness to use new expression platforms, coupled with a communicative culture, is adding value to contract manufacturing organizations (CMOs) and triggering a thriving price competition, particularly among CMOs involved in product development.

“CMOs are engaged in price wars, particularly on the mammalian side of the business,” notes Darren Head, president and CEO, Cytovance Biologics. He says this competition is driven largely by a growing variety of expression platforms that offer better titers and yields, or that improve other aspects of cellular output, such as structural properties, activity, immunogenicity, or toxicity.

CHO cells are just one example. They used to be the only commercialized vector for manufacturing antibodies and are still the dominant expression platform. But there’s also increasing commercial interest in using PER.C6, NS0, and HEK293 cell lines.

Likewise, the standard E. coli bacterial and P. pastoris yeast systems have been augmented with insect cell, baculovirus, and other expression systems. Commercial use of transgenic systems also is growing.

With multiple expression systems available, companies are comparing results from various systems early in their research and selecting the best for scaleup for individual projects. The consequent speed and cost savings lends a competitive advantage to the biopharma company, but also to the CMOs well-versed in alternative cell lines, Head explains.

In 2012, Cytovance Biologics completed a 1,000 L mammalian bioreactor suite at its biologics manufacturing headquarters. At the time, the new bioreactor was expected to complement the company’s existing manufacturing process trains—100 L and 500 L bioreactors, a 100 L Wave system, 50 L and 200 L Sartorius subs, and a 100 L microbial manufacturing train.

International Interest

International efforts in developing a thriving biotech industry also are spurring interest in western CMOs. “Many western companies operate in Asia, and the number of contract research organizations (CROs) there are growing. However,” Head stresses, “bioreactor capacity is limited. Very few CMOs operating in Asia are capable of producing products for manufacturing in a way that meets FDA guidelines.”

Cytovance, he adds, has several clients in Taiwan and sees great growth opportunity there. “The Taiwanese biopharma industry values American CMOs,” because of the perception of quality and their experience working with the FDA. Europe, in contrast, has ample, high-quality CMO capacity. Work there is based more often on a history of success and long-standing relationships.

At Cytovance, that history begins in 2003 when the management team spun out of Novazyme Pharmaceuticals. After frustrating client-side experiences managing CMOs, consultants and multiple ancillary service providers, the executive team put its expertise to work, designing Cytovance Biologics from a client’s perspective.

Based on its own experience, Cytovance’s management understood that clear communications could make or break a project. “Companies operate and communicate differently depending on their size and culture,” Head says, noting significant differences between even large and mid-tier biotechs.

In working with these differences, establishing clear communication pathways is vital. At Cytovance, this includes working with new clients to ensure they understand how a CMO operates and that they work with the project-management team established for their project and, within it, the designated point of contact.

Routing communications through a single point of contact, even though multiple team members are consulted, ensures the entire team functions with the most current information. “Understanding the communication pathways is vital,” Head emphasizes.

That’s especially true for biologic development. While the scientific challenges inherent in developing a drug from concept through commercialization ensure that no project ever progresses without changes, “Biologics, in particular, are unique. They’re living organisms, so expecting biologic development to go without a hitch is unrealistic,” Head says.

How you deal with those challenges is really critical, according to Head. In addition to establishing clear communication channels, “As a CMO, you must communicate with the client proactively.” That means advising pharma and biotech clients not only about corrective options and actions, but also identifying potential challenges early, before they arise.

For example, proactive management looks at the supply chain as well as the scientific and production elements of a project. Considering the supply chain allows managers to identify and plan for potential issues, like APIs that require long lead times or that are sourced from trouble-prone regions.

Communications glitches, not surprisingly, are most likely with new clients. “With on-going clients, communications and relationships already are well-established,” Head says.

Some of Cytovance’s relationships emerged through outside communication efforts. The CMO is active as a presenter at conferences and in discussing the biotech industry, entrepreneurship, and manufacturing with a new generation by contributing content to biotech textbooks.

Cytovance has established its niche in “true product development, clinical trial support and manufacturing for Phase I and II trials,” Head explains. “And, we’re anticipating our first pre-approval inspection from the FDA in mid-2015.”

He says nine INDs have been filed in the past nine months for projects Cytovance is developing with its clients and, “We’re moving toward commercial manufacturing.”

The company has three different manufacturing plants for microbial, mammalian, and other development technologies, like transgenics.

“Business is increasing 40 to 50 percent per year,” notes Head—so much so that its new 30,000 square-foot warehouse was redesigned to include a 1,000 liter fermentation area before the warehouse even opened two months ago.

In early 2014, Cytovance Biologics introduced a 200 L microbial fermentation suite and an automated fill/finish line at its biologics manu-facturing headquarters in Oklahoma City. The company expects to expand its capabilities for microbial services to 1,000 L in early 2015.

Cytovance Biologics

Location: 800 Research Parkway, Suite 200, Oklahoma City, OK 73104
Phone: (405) 319-8310
Website: www.cytovance.com
Principal: Darren Head, President and CEO
Number of Employees: 135
Focus: Cytovance Biologics is a cGMP-certified contract manufacturing company focusing on product development and manufacturing for clinical trials using mammalian, microbial, and new vector platforms.

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