Langer: The Future of Biomanufacturing: Towards More, and Better, Therapies

Improvements in biomanufacturing will lead to improvements in most everything that matters to industry and consumers, including more products, more variety, more diseases being treated, and more effective therapies.

By Eric Langer, President, BioPlan Associates, Inc.

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Advances in biopharmaceutical manufacturing technology, combined with current economic, healthcare and industry trends are shaping the future of healthcare delivery, and opening the door for more and better options for industry and consumers. 

The sheer complexity and cost of biomanufacturing clearly affect the cost of healthcare. Today’s economic environment is contributing to the changes in the way critical manufacturing decisions are being made. Our study, “Advances in Large-scale Biopharmaceutical Manufacturing” [1] compares trends over the past 15 years and show that, until recently, cost reductions were not the primary drivers to the strategic manufacturing decision process. Much of this can be attributed to the early industry’s urgent need to get products to market quickly, given the enormous investments and R&D expenditures.

Today, as biomanufacturing technology continues to advance [2], most companies are finding it vital to address manufacturing costs at multiple levels. Examples include novel expression systems, genetic engineering, cell lines, bioreactors, culture media and other upstream technologies [3]. Less than a decade ago, typical yields from large-scale manufacture of recombinant proteins were less than 1 gram/Liter; today, the average yield is nearly 3 grams/Liter [2], and yields in the 10 gram/Liter range are increasingly common.

In addition, small volumes, and flexible factories are increasingly common, as a result of changes to a bioreactor and associated equipment design. Now, small manufacturing suites can often match the capacity of massive, earlier-generation facilities. While advances in purification processing technologies have not yet matched these advances, these areas, too, are moving forward rapidly. The adoption of disposable equipment throughout biomanufacturing processes are also simplifying and decreasing the costs of biomanufacturing.

Lowering Costs to Consumers
These trends are lowering the costs of manufacturing, increasing the speed of scale-up and manufacture of products for clinical testing, and decreasing the cost of product development and all-important time-to-market. Biomanufacturing facilities, many using modular and disposable equipment, are increasingly able to manufacture biopharmaceuticals at world class scale, with these facilities requiring less infrastructure, supplies, land and labor, less costly to operate and capable of rapidly shifting to manufacture of different products. This contrasts greatly with much of the industry’s established (legacy) manufacturing capacity which often involves large, stainless steel and other fixed, single product-dedicated equipment, with most of this capacity devoted to established products, particularly blockbusters.

The evolution of biomanufacturing cost-control is taking place and complementing the trend of biopharmaceuticals displacing small molecule drugs. Biopharmaceuticals now account for an ever-growing portion of the pharmaceuticals in development, and represent expanding industry sales and profits.  There are currently about 400 biopharmaceuticals approved in the U.S. or European Union (EU) [4], including over 150 recombinant proteins, with many more in development, including over 50 biopharmaceuticals with applications currently pending in the U.S. or EU [1]. Large international pharmaceutical companies, most with ailing R&D pipelines, are increasingly licensing in and further developing biopharmaceuticals. These traditionally, ‘small molecule’ companies are also acquiring biopharmaceutical companies and manufacturing capacity. Major (e.g., multi-$10 billion) mergers, such as Pfizer acquiring Wyeth, and Merck acquiring Schering-Plough, primarily involve acquisition of biopharmaceutical products and pipelines.  Many of these large international companies even now describe themselves as biopharmaceutical rather than pharmaceutical or drug companies. 

As the biopharmaceutical industry matures, decreasing costs and improved biomanufacturing technologies will follow. There will be an increasing variety of products, ranging from fully innovative biopharmaceuticals, including whole new classes, such as gene therapies and cancer vaccines, to hundreds of biosimilars and biogenerics worldwide. With improvements in biomanufacturing, and increasing affluence in developing countries (especially China and India), an ever-increasing number of products, initially mostly biosimilars/biogenerics, will be manufactured outside of the major market countries. Most of these products will be distributed domestically, but many will make their way into markets without stringent regulatory oversight. Eventually, as developing countries establish the necessary regulatory and quality administration, even the U.S. and European markets will be opened to new competition. 

Biosimilars
As advances such as disposable manufacturing lower costs for entry, the manufacture of biopharmaceuticals will see increasing numbers of competitors, resulting in more rapid growth in the number and diversity of products and companies worldwide. If nothing else, improvements in biomanufacturing are enabling development of a whole new industry of biosimilars and biogenerics worldwide. Now, the question emerging is not whether biosimilars will be introduced, but whether these producers will be able to reduce costs of manufacturing these complex molecules enough that they can actually result in significantly lower costs to patients and third-party payers. Clearly, the massive R&D costs associated with biologics won’t likely go away, nor will the costs of regulatory or clinical management for drugs. So, even a substantial reduction in manufacturing costs may have only incremental effects on overall costs. 

More and Better Biologics
Spurred largely by these improvements in biomanufacturing, biologics that were previously thought to be too costly or difficult to produce may be considered viable drug candidates. There will likely be an increasing flow of biopharmaceuticals of all types in the marketplace, including new biosimilar products. There will also be a significant increase in innovative biopharmaceutical development and manufacture, as more funding and more companies get involved, worldwide. This may include countries currently not involved in pharmaceutical R&D. There will be more biopharmaceuticals of all classes coming to market in coming years for different, currently untreatable, diseases. This will include a large number of recombinant monoclonal antibodies, many for treatment of various types of cancer and chronic diseases.

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