Vaccines & CMOs

What have we learned from H1N1?

By Gil Roth

Contract Pharma

Around this time last year, we explored the role of contract service providers in the vaccine market. That article was written against the backdrop of H1N1, the swine flu variant that we feared would become a global pandemic of massive lethality. The jury’s still out on why H1N1 largely fizzled out, but that doesn’t mean lessons weren’t learned throughout the healthcare sphere.

Kalorama Information recently published a report on Europe’s vaccine market (http://www.kaloramainformation. com/redirect.asp?progid=79864&productid=2833006) that mentioned how the continent’s adult flu vaccine market shot up 81% to $1.6 billion in 2009. In financial statements and earnings calls, vaccine makers took pains to separate out their pandemic flu sales figures, to smooth out the rest of their quarterly earnings. That got me wondering how vaccine-related CMOs — most if not all privately held — were dealing with the peaks and valleys of pandemic demand.

I asked Kalorama’s publisher, Bruce Carlson, for his opinion about the post-H1N1 market and how it may impact CMOs. He told me, “We do know that companies like Glaxo and Novartis went into a kind of overdrive that might not have been sustainable for a second or third year — they went through extraordinary procedures for manufacturing the H1N1 vaccine for various governments — contracting with egg suppliers and CMOs before competitors could, bringing all personnel, including management in some cases, into the vaccine project, and hiring temporary workers to manage contracts, supply logistics and projects.”

He added, “I would be curious to see what might be going on in sponsor relationships with CROs and CMOs now that the big order from last year isn’t there.”

So I decided to check in on our sector of the industry to find out what lessons some of our CMOs learned from H1N1. Most of them wouldn’t discuss the ups and downs of revenues, but it’s clear that the H1N1 experience affected how some of them are doing business. Here’s what they had to say:

JHP Pharmaceuticals

“H1N1 presented a more extreme example of performance requirements of a CMO. In responding to the pandemic, the scale of the undertaking was quite large and the specific product needs kept evolving over a relatively short period of time. The CMO and sponsor needed to maintain intense and transparent communications to ensure the deliverables were aligned with the changing product specifications. It also highlighted the importance and benefit of being positioned beforehand in areas such as site licensing, so that when such needs arise, there are adequate numbers of CMOs available to provide timely and appropriate service.”

—Stuart Hinchen, president

OsoBio BioPharmaceuticals

“In the bigger picture, I think the country has learned is that it’s necessary to maintain an inventory of assets to be marshaled for this sort of activity. BARDA [Biomedical Advanced Research and Development Authority] is trying to rectify that situation.

“For CMOs, one of the major lessons was that it’s not just we who need to be ready. All the suppliers along the chain — like glass, for example — are vulnerable. Somewhere, there needs to be a buffer capability for support infrastructure.”

“As you’d expect, the H1N1 episode was stressful for OsoBio as an organization, but the experience taught us the value of rapid response. We were able to get our part done because it was an emergency, and now that we’ve been through it, we know we can respond more quickly if the need arises.”

—Stuart Rose, president and chief executive officer

Cook Pharmica

“Speed is obviously vital in vaccine manufacturing, so we selected equipment with speed in mind. Our syringe line, for instance, can fill at a rate of 600/minute. Batch-turnaround speed is also important, so we incorporated clean-in-place and steam-in-place technologies for campaign purposes.”

—Ryan Hawkins, director of Parenteral Manufacturing

“Finishing speed was also a consideration. Having our filling, inspection, labeling and packaging capabilities all at a single location allowed — and allows — us to get vaccines to patients as quickly as possible.”

—Brian Arnold, brand and marketing manager

Grand River Aseptic Manufacturing

“We learned that there continues to be global insufficiency in manufacturing capacity for the vaccines markets. Those CMOs willing to invest in additional capacity will capitalize significantly in light of Big Pharma’s intention for targeting growth in the emerging markets, where disease prevention is the trend, rather than disease treatment.”

—Gregory T. Gonzales, president

Lonza Custom Manufacturing

“At Lonza we’ve witnessed a steady growth in the vaccine portion of our portfolio. The clear trend is toward recombinant vaccine ingredients and away from the older attenuated and inactivated product types. Lonza’s strong position in microbial and mammalian recombinant production technology has allowed us to increasingly meet the needs of vaccine companies large and small. Also, through a recent acquisition, we have added virus culture technologies and capabilities to become a truly full-service vaccine manufacturer.”

—Janet White, head of Development Services

Baxter BioPharma Solutions

“We are heavily focused on serving the needs of our customers and the patients they serve worldwide. In situations where the healthcare environment requires unique services, such as during the H1N1 event, it is critical to have the experience and ability to deliver on an influx in volume demands. Baxter has manufactured sterile products for more than 80 years and this expertise has been an important contributor to our ability to deliver on the fluctuating needs of health providers.”

—Kristie Zinselmeier, director, Marketing

HollisterStier DRAXISContract Manufacturing

“Some of what we learned was singular, only applicable to that unique situation, but I think there were two key takeaways from the vaccine buildup last year. These included refining and improving our accelerated transfer capabilities, and developing an integrated client development protocol for manufacturing process design.

“We were glad to learn that we can respond to the urgent request of a pandemic, but what’s more repeatable is the speed of bringing clients into our facility. Specifically, the experience helped our team developed robust project management

capabilities.

“The key is simplifying the transfer process, in order to get projects in quick and get them filed. When you can go from concept to batches in three months, as we had to in this case, you’ve proved your methodologies work.

“The other lesson was in manufacturing method improvement. Prior, HS was comfortable in its role as a fill/finish site. We would evaluate business on a one-off basis, telling clients, ‘Finalize your method, and we’ll make it at scale.’

“H1N1 gave us such a short lead time that we couldn’t just tell the client to bring us the method. We had to work with them to develop it. As a result, we’re much more able to support clients with method development capability. We can do development work to help scale up.

“So, we’ve returned to building our business through organic client management, but we believe we’ve grown from the H1N1 experience.”

—Marcelo Morales, chief executive officer

DSM Pharmaceuticals

“This was an enormous challenge for our Greenville, NC site, considering that we had not produced vaccines/adjuvants before and the timelines set by our sponsor companies were greatly accelerated.

“Specifically, we learned faster, more efficient ways to communicate, both internally and externally. As a result we have seen ongoing reduced cycle times in such areas as batch release and change control. And we have gotten better at project management because the nature of the H1N1 tech transfers required very close and flexible interaction between the sponsor teams and the DSM teams.

“With regard to the bigger picture, we have learned that by closely working together across departmental boundaries and truly ‘thinking out of the box,’ we can remove most real and perceived obstacles. We can be innovative without compromising our quality standards.

“And finally we learned — or were reminded — just how closely connected our work is to the everyday health and well-being of patients across the globe.”

—Hans Engels, president and business unit director

Gil Y. Roth has been the editor of Contract Pharma since its debut in 1999. He can be reached at gil@rodpub.com