Almost every aspect of the biopharmaceutical and medical device industries raises regulatory compliance concerns. Heightened scrutiny is required across product lifecycles — from clinical trials to manufacturing, pricing, formulary placement, and promotional practices. Those areas (as well as patient privacy and adverse event reporting) require close attention to and compliance with healthcare laws, regulations, and guidelines. Part 1 of this two-part article describes statutes, regulations, and guidances applicable to the biopharmaceutical and medical device industries. Anti-Kickback and False Claim Laws…
Business
An Industry Perspective on Quality By Design
The US FDA’s quality by design (QbD) initiative and associated ICH Q8, Q9, and Q10 guidance documents are increasingly embraced by the biopharmaceutical manufacturing industry for ensuring consistent product quality and lower costs of development and manufacturing. One critical problem the industry faces involves understanding how to implement QbD and determine the benefit of such projects — which require the work of many groups across quality, manufacturing sciences, and engineering departments. Here we present the results from a survey of…
Success Stories from the Asia–Pacific
The Asia–Pacific region is a vast geographic area with a loose definition — covering East Asia, Southeast Asia, and Oceania. It includes a variety of cultures and races and is home to both developed and developing countries. Depending on the definitions of the region, the gross domestic product (GDP) varies from $500 per capita in East Timor to $41,500 in Australia, and the populations climb from a mere 55,500 in Australian Samoa to a vast 1.3 billion in China (1).…
Upstream Single-Use Bioprocessing Systems
Single-use bioprocessing equipment has become well-accepted technology in a relatively short time. Disposable devices and components have created market niches and new segments that continue to evolve. In this dynamic environment, it is difficult to measure acceptance or assess market growth. Here we project the world market for cell culture single-use systems (SUS) as well as problems affecting that market, including adoption for commercial manufacture. This is based on our 10-year analysis of the industry, with data from our eighth…
Ensuring Aseptic Processing Through Quality By Design
Assurance of sterility throughout drug manufacturing is paramount to patient safety. Drug products must be free of contamination from microbes, particulates, and chemicals. To that end, we see continued and increased regulatory scrutiny, with adoption of US Food and Drug Administration (FDA) and European Medicines Agency (EMA) standards outside the United States and the European Union. To consistently make microbe-free products, drug manufacturers must implement robust, validated processes that include sterilizing filtration. Sterilizing-grade filtration is used in a number of…
Analysis and Immunogenic Potential of Aggregates and Particles
The conclusion of this CMC Forum continued to focus on the latest developments in detection and characterization of protein aggregates (1). Afternoon sessions detailed the most recent experiments probing the role of protein aggregates in immunogenicity, with discussions on the best models to use and initial results. Topics included potential thresholds for immunogenicity, linking laboratory and clinical data, and predicting and testing potential immunogenicity of products throughout a development lifecycle. Afternoon Sessions Amy Rosenberg (Division…
Shifting the Bioprocess Paradigm
The need for transformation is a powerful driving force in the biopharmaceutical industry. Opinions and predictions about the best way forward are plentiful. As drug developers seek to enhance productivity, reduce costs, and improve their return on investment in research and development, new ways of doing business are explored, evaluated, and acted upon — with varying degrees of success. Faced with intense pressure to evolve, the biopharmaceutical industry is smart to leverage approaches that have driven success in…
Addressing Image-Based Compliance and Validation Issues
Review times for 510(k) submissions have increased by >55% since 2005 because of poor-quality submissions by medical device manufacturers, according to a US FDA July 2011 report (1). Such setbacks can debilitate research and development (R&D) budgets of medical device and pharmaceutical companies and significantly affect their return on investment. As the FDA increases scrutiny of submissions, organizations must ensure adequate controls in assessing drug and device efficacy for preclinical animal studies and clinical trials. Doing so lends…
Clinical Development of Biosimilars
Biosimilars require comparative studies that are different from the typical placebo-control clinical trials for first-generation proteins. A typical clinical trial programs must show equivalence of a biosimilar to the originator protein. Hans-Peter Guler, senior vice president of clinical development at INC Research, recently discussed with me the primary objectives and approaches to conducting an equivalence design. By contrast with trials for originator proteins, equivalence trials require a different statistical approach. The biosimilars company needs agreement from the…
How QbD and the FDA Process Validation Guidance Affect Product Development and Operations, Part 2
Earlier this year, the FDA issued its long-awaited process validation guidance document, which had been several years in development. It is well written and effectively articulates what many progressive companies have been thinking and doing for years. But many people in the industry are asking questions. Part 1 of this article described the history of process validation before the FDA’s quality by design (QbD) initiative and discussed QbD in general. It also described the new process validation…