Vaccine makers are leading the way — that’s something you don’t hear every day. For many years, vaccines were seen as “old-school” and less profitable than other biologic products — and they were the business of just a few huge companies. But thanks to recombinant technology, it’s a real Cinderella story: Advancing technologies led to what’s being called the “vaccine renaissance.” And now, vaccine companies may have something to teach their biopharmaceutical brethren.
In April 2004, BPI may seem to have been speaking too soon with its “Vaccine World” supplement, in which I wrote of cell-culture–based vaccine manufacturing as though it were a done deal (
1
). It made perfect sense to me (as a technically inclined but not economically inclined sort of person), especially for the new vaccine products that were being developed (
2
). In the same special issue, two former BPI editors pointed to another aspect of the vaccine business that was driving it in new technical directions: the conflicting economics of ...
Compared with other business sectors, the biopharmaceutical industry has been a high-tech laggard when it comes to outsourcing and off-shoring. That’s changing as companies acknowledge the strategic, cost, and market benefits. Over the past seven years of tracking outsourcing trends (
1
), I’ve seen interest in outsourcing grow, but that has kicked into high gear over the past couple years. Partly due to the economic and funding crisis and partly as a result of industry maturation, outsourcing is taking greater prominence as biopharmaceutical companies gain experience in managing outside operations. Bioexecutives are considering outsourcing models and creating the tools needed to assess different operating strategies.
This year, our seventh annual survey of biopharmaceutical manufacturing and capacity analyzed the data of 327 global biomanufacturer respondents and 125 suppliers to this industry. As detailed in the “Survey Methodology” box, the results cover a broad range of issues including capacity and o...
The idea of “thinking globally, but manufacturing locally” to each market is relatively new to the biopharmaceutical industry. As I mentioned in Chapter 2, vaccine makers are more familiar with the concept already. But many technological and economic factors are making other companies aware of this option. Offshoring clinical trials has been of great interest in the pharmaceutical industry for years now. Is it more cost-effective to make clinical materials “here” and ship them “there”— or to make them where they’ll be used? Can you maintain proper control over product and process, not to mention intellectual property and regulatory compliance? As with any other business strategy, these are not ventures to be taken lightly. There are pitfalls to avoid and rough waters to navigate along the way — and this kind of globalization may not be the way to go for some. For others, however, it could provide solutions to some very daunting challenges standing in the way of their success.
Recently Novozymes Biopharma’...
As the biopharmaceutical industry undergoes restructuring, its focus shifts to the efficiency of drug development and overall costs of delivering affordable medicines. A question often raised concerns the manufacture of drug substances overseas to tap into a cheaper manufacturing base (
1
). There are many issues to consider when looking at overseas locations, such as intellectual property (IP), the availability of skilled labor, and the emergence of new markets. The situation is more complex with biopharmaceuticals because the products themselves are difficult to characterize, which means close scrutiny of all systems manufacturing, quality, and supply chain. However there are successful overseas manufacturing companies supplying vaccines through World Health Organization (WHO) programs, and blood fractionation facilities and established biopharmaceutical manufacturing operations are already operating in Cuba, China, Japan, Singapore, and India.
I’m focusing on the economic aspects of biopharmaceutical m...
One response to a survey we sent out last year kept coming back to me as we prepared this issue. In answer to what a company does if a product in development doesn’t fit into the company’s platform technology, one answer was, “We innovate a solution.” Whether meant seriously or not, it rings true to the history of the industry’s ability to invent and reinvent solutions as necessitated by economic realities.
When we began working on the topic of this special issue, we thought we knew the trends and would simply be offering examples of the burgeoning of “local” manufacturing around the world. We assumed that the global biotech industry had reached a sort of geographical “tipping point,” when in actuality, the choices appear to be much less clear-cut. It is true that what has in the past been accomplished by vertically integrated companies in major biotech hubs can now be done pretty much anywhere in the world. This presents companies, new and established, with a number of business models and options — but n...
For a growing number of biopharmaceutical companies, the world is getting smaller. They are operating in smaller, more flexible facilities; servicing potentially smaller markets; and managing local products. Local manufacturers are looking for ways of doing standard processing less expensively without making changes that carry regulatory risk. Most of these facilities are vaccine manufacturing sites. The upsurge in localized diseases and need for global pandemic preparedness (especially under uncertain capacities) have countries such as Malaysia, India, China, and Brazil pushing for local production plants to supply vaccines and other drugs. Legislative and social changes such as US healthcare reform, worldwide recessions, and the push for increasing biosimilars are driving the need for greater manufacturing efficiency. To become more efficient in processing, localized manufacturers will need to become aware of the impact of social, legislative, and technology factors that are fueling this trend toward de...
As much as one-third of the world’s population lacks access to essential medicines, and in the poorest regions of Africa and Asia, this figure rises to one-half (
1
)
.
Along with other organizations,
Medicins sans Frontieres
(MSF, Doctors Without Borders) advocate for a combination of global and regional policies to lower drug prices sustainably, including local drug manufacturing. At this year’s annual meeting of the Biotechnology Industry Organization (BIO), during a session on building vaccine capacity in developing countries, Martin Friede of the World Health Organization (WHO) told the audience, “It is not only essential to manufacture vaccines locally, but we must allow each region to make its own decisions.”
One of the biggest barriers to meeting this objective is the lack of manufacturing capacity in developing regions. During the same BIO session, Eric Iverson of the Gates Foundation stated that the lack of capacity is “a rate-limiting constraint to achieving global health objectives.” Althou...
Business or research groups planning to expand research, manufacturing, sales, or distribution activities beyond the United States should plan for compliance with US and international export and import rules and understand how these rules apply to various technologies. Export and import requirements can be complex and highly technical. Failure to allow for the long lead times needed to frame and implement internal export policies and procedures as well as engage third-party export services can lead to additional expenses, delayed export schedules, financial penalties, and criminal charges. Recent aggressive enforcement of US export laws have resulted in civil penalties amounting to >$100,000 against several companies engaging in unlicensed exports and re-exports.
Initial Considerations
Specialists must plow through lengthy and complex commercial export rules and packing, labeling, and shipping requirements. A general understanding of such rules in the United States (as well as related costs) is essential ...
With combined 2009 revenues estimated to be over US$40 billion, monoclonal antibody (MAb) products have become the dominant component of the biopharmaceutical market (
1
). Continued interest and development of this exciting class of products will drive the overall sales of biopharmaceutical products in the future, making them the fastest growing segment of the overall pharmaceutical market (
2
). To help companies developing MAb products, BioProcess Technology Consultants recently published a comprehensive report outlining the complex technical, regulatory, and strategic chemistry, manufacturing, and control (CMC) activities necessary to successfully advance new MAbs from discovery to first-in-human clinical trials and the market as quickly and economically as possible (
3
). As discussed in the report, numerous interconnected tasks must be completed cost effectively and on schedule to enable human clinical testing of a new MAb candidate. Those tasks include construction and testing of production cell li...
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