At every stage of biopharmaceutical development, efficient and cost-effective protein production is critically important to maintaining the economic viability of both a product and the company developing it. Biopharmaceuticals have significantly evolved through recent protein engineering advances, resulting in highly complex, novel proteins dominating the development pipeline. Such proteins are by definition very difficult to express in a soluble and active form. The success of these products depends on accessing a platform that rapidly produces high-quality, properly folded,…
Business
Tax Credits and Incentives Can Offset Research Costs
Looking ahead to next year’s tax season, you can maximize the benefits of available US tax credits and incentives. A powerful incentive known as the research and development (R&D) tax credit is available at federal and state levels to help companies recover a significant amount of their R&D costs. Organizations that qualify for the credit range from small farming collectives investing in improved livestock breeding methods to pharmaceutical and medical device companies developing new products. The key factor…
30th Anniversary of Smallpox Eradication
May 2010 marked the 30th anniversary of the World Health Organization’s declaration that the world had won freedom from smallpox. An intensive two-year search had discovered no evidence of the disease since the last case on 26 October 1977. It was a historic moment — no disease had ever before been eradicated. Smallpox had terrorized humans for more than 3,500 years and in the 20th century alone had been responsible for 300 million deaths. The success of the…
Building Regulatory Compliance for Personalized Medicine
Regulatory compliance is the means by which biopharmaceutical companies bring new medicines to market. But as we embark on developing and bringing to market more complex, more personalized medicines in the 21st century, we are about to find that our most experienced sources of compliance know-how and intelligence are getting ready to leave for the comforts of retirement. Demographics are working against the biopharmaceutical industry. Survey Results A 2006–2007 survey by the University of Southern California…
Containment of High-Potency Products in a GMP Environment
Many modern medicines are highly potent, with only tiny doses required to achieve a therapeutic effect. But a nanomolar medicine poses extra hazards during manufacturing, whether the product is a biologic or a small molecule. These issues have to be evaluated and addressed in the design of a manufacturing facility for such products. Not only is it vital that the product not become contaminated, but employees and the general public must be protected from the product. Exposure to just a…
Influence of Process Development Decisions on Manufacturing Costs
As we have discussed, cost has not always featured highly during bioprocess development, in which traditionally the focus was on product quality, regulatory compliance, and speed to generate material for the clinic (1). As the industry matures in commercializing successful products, increasing competition (both from competing products and biosimilars) leads to issues of cost and manufacturability coming to the fore. Solutions adopted will depend on each organization: At one extreme are small biotech companies developing novel therapeutic proteins;…
Geographic Strategies in Biomanufacturing
In BPI’s June issue, we presented a supplement on geographical trends in biomanufacturing. We looked at the influence of a growing demand for biotherapeutics in emerging countries and the influence of new technologies that are driving interest in smaller, perhaps more geographically distributed production. We wanted to explore what a global bioeconomy would look like and where its primary capacity would be concentrated. Authors provided examples of how to balance cost with control issues. They talked about working in different…
Manufacturing Convergence Technologies
Many regenerative medicine products represent a convergence of pharmaceutical, biologic, and medical device technologies. Although such products could have a great impact on medicine, they often pose significant challenges for their developers, requiring companies to incorporate competencies from several technology sectors. By addressing commercial regulatory and manufacturing challenges at an early stage in product development, these companies are more likely to succeed in reaching their commercial goals. Exact regulations governing the manufacture of a convergent technology — or…
Measuring Manufacturing Cost and Its Impact on Organizations
The first article in this periodic series reviewed the impact of cost pressures on the biopharmaceutical industry, in particular the challenges the industry faces in relation to high capital costs, complex processes, and long product development cycles (1). Here we examine what companies are doing to assess costs in decisions about process and technology choices relating to manufacturing of biologic drug substances. We will look into what companies are currently doing and what they need to be doing…
Manufacture Locally, Market Globally?
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…