RecipharmCobra Biologics, Keele (previously Cobra Biomanufacturing Plc) has been producing plasmid DNA for clinical trials for more than 10 years and has an approved site under the EU clinical trials directive. During this period, the company has produced more than 40 plasmids (ranging from 500 mg to 5 g) for 25 customers in Europe and the United States. These plasmids have been used for gene therapy and vaccines as well as to produce viral vectors. RecipharmCobra has developed…
Business
Review, Approval, and Marketing of Biosimilars in the United States
During the past 30 years, advances in medicine and pharmaceutical research generated a new class of drugs called biologics. These drugs are complex proteins, carbohydrates, or other large molecules derived from biological sources (1). By contrast with more traditional pharmaceuticals (small-molecule drugs), biologics are not synthesized chemically from less complex components, but rather are derived from or manufactured using living organisms or extracted tissue (2) Biologics make up a small but significant percentage of the overall pharmaceutical market.…
The Human Factor in Facility Design Innovation
Bioprocess and pharmaceutical production environments must be well designed to meet strict cleanroom and quality assurance (QA) standards and productivity requirements. Managers may also consider innovative ways to enhance the design of these environments to enable the people critical to their companies’ success to be more productive and effective. In today’s work culture, countless hours can be lost to poor teamwork and ineffective communication. CGMP environments present additional, unique challenges to human interaction because of their built-in process and protocol…
Risk Mitigation Through Improved Process Predictability
Unexpected events — whether catastrophic like the oil leak in the Gulf of Mexico or a disruptive supply chain shortage — can change the future of a company. To prevent such difficulties or at least minimize their impact, life sciences companies spend millions of dollars on daily analysis of enterprise-wide risks. Whereas supply chain and logistics are traditionally a focus of risk analysis teams, manufacturing and quality teams are now charged with improving process predictability. Through process understanding, that not…
Technology Transfer Challenges for In-Licensed Biopharmaceuticals
During the lifecycle of a biopharmaceutical, occasions arise in which the facility and support organization responsible for ensuring that it is manufactured according to schedule, demand, and quality specifications must change, either in whole or in part. The reasons for this vary: some related to scale, some related to clinical development phase, some related to internal manufacturing capacity and program ownership. The industry has adopted the term technology transfer to describe these events. Many such situations have been…
Modeling Bioprocess Cost
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,…
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…
Working Toward Animal-Free Processing
Biological therapeutics is one of the fastest growing segments of the pharmaceutical industry — so much in fact that the overall cell culture media and supplements market used in bioprocessing applications is reportedly near $800 million (1). An increasingly important trend in cell culture is risk reduction throughout the supply chain, including a stringent focus on key raw materials. Accordingly, the industry has increasingly adopted animal-component-free materials to mitigate concerns over safety, transmissible spongiform encephalopathies, and other contaminations.…
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…
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…