The growing and dangerous counterfeit drug problem is a troubling, global epidemic that can — and does — harm patients who are merely trying to get well. Efforts to address the problem are hamstrung for a variety of reasons: Americans don’t see the immediate threat, this global public health problem needs a coordinated global response, and too many stakeholders are more focused on self-interest than on working together to find a solution. The Partnership for Safe Medicines (PSM)…
Business
US Supreme Court Ruling Provides Clarity for Life-Science Companies Facing Litigation
When a company is involved in litigation, the court in which its case is heard can have a significant impact on the proceedings. For life-science corporations, this is especially true. Because their products are often distributed to consumers across the United States and the world, such companies can benefit from the consistency and efficiency provided by federal courts. Federal courts provide uniform procedures across the United States, have mechanisms for consolidating similar claims across state lines, and are…
Review, Approval, and Marketing of Biosimilars in the United States
Development, testing, review, approval, and marketing of biosimilar drugs in the United States presents unique safety and regulatory challenges (1). By contrast with traditional small-molecule drugs, biologics derive from sources such as genetically engineered cell lines, plasma, and tissue specimens (2,3). Patents on first-generation biologics approved and marketed in the United States have begun to expire, thereby opening the market to less-expensive “generic†versions. The complexity of biologic drugs and the specificity of their source materials, however, make…
Ongoing Challenges of Applying QbD to Biopharmaceutical Products
Quality by design (QbD) was a hot topic at IBC’s BioProcess International Conference and Exhibition, 20–24 September 2010 (Providence, RI). For her keynote address, Helen Winkle (director of the FDA’s Office of Pharmaceutical Science) discussed the agency’s continuing efforts to improve product quality regulation as well as opportunities and challenges of implementing QbD for biotechnology products (1). Since introducing its 21st Century Initiative in 2002, the FDA has made some headway toward enhancing product quality through QbD (2). The QbD…
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…
Scale-Up of a Plasmid DNA Purification Process
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…
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…
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.…