March saw the launch of a major contract development and manufacturing company, DPx Holdings, B.V., a merger between Royal DSM’s pharmaceutical businesses and Patheon that combines their assets in API, biologics, sterile, liquid filling and lyophilization, as well as finished dosage form manufacturing.

Merging two corporate cultures is always a challenge, but the new company has been moving forward with several projects that reflect its new capabilities, and enhanced focus on the customer.

Last month, for instance, DPx Holdings, B.V. formally announced its Operational Excellence program called Driving Performance eXponentially or DPx. The program is built upon the strengths and success of existing programs and will be rolled out at all sites globally and has already begun at the Greenville, N.C.; Linz, Austria; Cincinnati, Ohio; and Toronto, Canada sites. The DPx Operational Excellence program focuses on continuous improvement and performance for the organization and is centered on a commitment to Right First Time and On Time Delivery. 

We spoke briefly with Francisco Negron, SVP of North American commercial operations and global CMO integration for DPx Holdings, B.V., for his perspectives (p. 30) on these and other developments, and an update on the company.

Combining OpEx Cultures
Launched in May, DPx Holdings, B.V.’s integrated OpEx program, DPx Operational Excellence, focuses on continuous improvement and performance for the organization and is centered on a commitment to Right First Time and On Time Delivery. DPx will be executed through three drivers, including Lean and Six Sigma; visual management tools and performance boards to monitor key indicators; and employee engagement and empowerment. These three components allow quality, timeliness and efficiency to be measured and result in greater performance and employee satisfaction.

“We truly believe our commitment to excellence is second to none in the industry and drives our culture,” said Harry Gill, senior vice president, quality and operational excellence. “ DPx will allow all sites across the globe to have the same mindset and focus, which will ensure that we are all delivering on our commitment to our company as well as our promise to our customers.”

DSM Pharmeceutical Products’ formal operational excellence and advanced manufacturing programs started in the 1990s, and the company’s focus has always been on process control and asset utilization, with a toolkit that included Six Sigma, Lean, OEE, analytics and change management.

Patheon, meanwhile, had launched its formal program seven years ago, establishing 18 KPIs at nine of its facilities, which led to its first Patheon Advantage program and to the company offering customers a performance guarantee for product quality and timeliness.  This program was followed by Patheon Advantage II, which broadened the original one to address more fundamental issues, including culture and management infrastructure. Patheon’s Advantage II was used to improve the Right First Time performance at several of the company’s facilities, according to Gill, who gave a presentation at CPhI/ICSE 2013 in Frankfurt, Germany, on this topic.

Enhanced Customer Focus, Investment in New Technology
This Spring brought a lot of activity in Europe. In April, the company’s solid oral dosage and nonsterile liquids plant in Bourgoin, France, received FDA approval. The facility had previously been upgraded with new technology, including potent drug containment and innovations in granulation, compression, packaging and bottling. “FDA approval at the Patheon Bourgoin, France site confirms the ability of the site to produce high potent new generation life-saving treatments worldwide,” says David Lescuyer, Executive Director and General Manager, Bourgoin Operations. “New investments in state-of-the-art confined equipment are supporting the site’s strong position as a major solid dose products and development services provider.“

That same month, DPx entered into a strategic coproduction partnership with Pacira Pharmaceuticals, to build dedicated Exparel (bupivaccine loposome inectable suspension) manufacturing suites in Patheon’s sterile manufacturing facility in Swindon, U.K. 
Pacira will be responsible for building the dedicated manufacturing suites, installation and validating manufacturing equipment. Two years ago, Patheon had considered closing the U.K. the plant.  Now, the company has taken a new approach to flexible customer partnerships at the facility and continues to work to help determine creative solutions for its customers’ needs.

“The new strategy at the Swindon site will open it up to a very broad range of yet unspecified technologies,” says Martyn Botterill, Executive Director and General Manager of the Swindon facility. In some cases, that could involve more traditional pharma technologies used in a manner to satisfy the niche requirements of a client or very specific technologies specifically designed and developed for the peculiar requirements of a clients’ product.”

The move represents a strategic partnership, he explained, in which the site and client develop the best solutions for future supplies, providing the specialist services required by the client but at all times maintaining a close collaborative relationship, often with a client representative or “person in the plant,” says Botterill. “The site has two established contracts operating in this manner and the project with Pacira, which has just been announced, is due to proceed into commercial supply late in 2016.” 

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Contract Pharma: Tell us a bit about the thinking behind the merger and what has happened since it was formally announced three months ago?
Francisco Negron: We’re excited about the merger and what it means for us. We came up with the strategy three years ago based on our position in the industry and market insights. The evolution of the concept was really an internal process, and was designed to drive the customer experience and leveragy the expected consolidation within the industry.

In North America, we now have our first sterile liquids operations, which was a goal for us three years ago. Remarkable work is being accomplished with our customers at our Italian sites, and we hope to see similar growth for our customers at our facility in Greenville, N.C., by again sharing best practices and increasing our customers’ experience. 

We also see the Brindel site playing a key role.  We have a very strong commitment to quality and compliance, and a strong track record in each. We also expect significant growth in the sterile liquids business in North America, and at the rest of our sites.

CP: What investments have you made in new technology to enable this approach?
FN: Over the last three years, we have been very systematic about adding capacity in North America, but we recently added granulation, coating and compression at our oral solid dosage forms plant in Toronto.

We’ve also realized capacity investments in our Puerto Rican plant, a medium-to-high-volume production site, and, in general. we continue to invest in capacity capabilities.

Flexibility is critical, customers need to manage capacity utilization, and we believe in maintaining a high utilization rate. However, we also need to keep a flexible response.

CP: What is happening in the company’s biopharma operations?
FN: We have been supporting the biopharma business for a long time.  The merger added biopharma and biosolutions, such as microbial growth and mammalian cell culture, to the Patheon Pharma Services business owned by DPx Holdings, B.V.  We have capabilities and capacities in our facilities in Europe and Australia. Both high-density cell-derived platform, and microbial fermentation are strengths, and have been a new focus since the merger. 

We are a very customer-focused company, and our recent project with Pacira reflects that focus. Specifically, we looked for how we could partner with Pacira and provide them with a solution to their manufacturing need.

CP: Both of your companies were very active in Lean, Six Sigma and Right First Time. What will you be doing in Operational Excellence? 
FN: Even during our due diligence period, before the merger, we knew that both companies’ commitment to OpEx would be critical to our success. OpEx was an area of common focus for our legacy companies and the merger brought our two programs together. DPx’s new program, formally introduced in mid-May, is called Driving Performance eXponentially or DPx. 

CP: Pharma doesn’t tend to have a very high capacity utilization rate, as an industry. How high is DPx’s capacity utilization currently and what is the goal?
FN: For capacity utilization, assuming 7 days, 24-hour 365-day operation, our goal is to be using 80-85% of capacity. It takes this level of utilization for any company to be truly competitive.

We’re driving performance through OpEx. Pharma has a challenge as an industry, where OpEx is concerned, and we’re taking that challenge head on.