We at BPI had so much fun putting together our big anniversary retrospective issue last year that we decided to make it an annual tradition starting this year — albeit on a bit smaller scale. There’s a lot to say when you reflect on 20 years of progress, problems, and solutions. But what can you say after only a year? Well, it turns out that the answer to that question, as you’ll find in these pages, is “Plenty!” The past…
Biopharmaceutical researchers, manufacturers, and regulators converged on Washington, DC, in January 2023 to attend CASSS’s 26th annual Well-Characterized Biological Products (WCBP) meeting. Among the opening festivities at each such event is conferral of the prestigious William S. Hancock Award for Outstanding Achievements in Chemistry, Manufacturing, and Controls (CMC) Regulatory Science. The prize honors people who have spurred on significant advances in scientific principles, applied technologies, and science-based regulations for biomanufacturing process development, characterization, analysis, and quality assessment. The 2023 recipient…
The biopharmaceutical industry is, and always has been, rife with mergers and acquisitions (M&A) activity, with small biotechnology companies combining technology and platforms, mid-size organizations diversifying pipelines, and larger corporations replenishing products under the weight of expiring intellectual property (IP). And then come the multibillion-dollar megamergers: Glaxo Wellcome and SmithKline Beecham, Pfizer and Wyeth, and Merck and Schering-Plough, for example. Few people expected 2022 to be an exception. According to a recent Ernst & Young (EY) report, the industry’s value…
New competitors entering the bioprocessing industry during the COVID-19 pandemic gained access partly because of unprecedented demand and constrained supply of bioprocess materials, equipment, and consumables. During the pandemic, growth in supplier revenue increased dramatically, averaging >24% growth in 2022, with some segments of the industry showing even higher growth (1). The 20th annual report of biopharmaceutical production from BioPlan Associates also assessed price changes and competitive pressures resulting from the demand swings over the past few years. The bioprocess…
Life-science companies must stay on top of new requirements, innovations, process improvements, and potential roadblocks to navigate complexities across the development, manufacturing, and regulatory life cycles of their products. Amid the increasing availability of cutting-edge technologies such as artificial intelligence (AI) and blockchain ledgers, organizations must establish best practices to support strategic decision-making, improve information collection and sharing with key stakeholders, and prioritize supply-chain management. Below, I share some insights from our team about emerging digital technologies and their implications…
A digital twin (DT) is a theoretical representation or virtual simulation of an object or system composed of a computer model and real-time data (1). A DT model operates upon information received from sensors reporting about various aspects of the physical system and process, such as temperature, raw-materials levels, and product accumulation. From such data, the model can run simulations that enhance process development and optimization. It can predict specified outcomes, flag required actions, and even support closed-loop process control…
Addressing sustainability can seem insurmountable for any business. Doing so requires endorsement from senior leadership and engagement from an entire organization. To ingrain sustainability into a company’s everyday activities, company leaders must enact strategies that are easy to implement, that produce results quickly, and that will promote long-term goals. Embracing a cycle of continuous improvement is crucial because today’s challenges and innovations can shape the norms of tomorrow, when new challenges inevitably will emerge. Environmental and social governance lies at…
Cell and gene therapy (CGT) applications have increased rapidly over the past few years, with hundreds of candidate treatments entering the clinical pipeline annually. Although North America, Asia, and Europe are driving industry growth, drug sponsors in those areas will not want to limit product distribution to their respective regions; rather, they will want to maximize patient impact. Thus, companies must understand global regulatory differences and their implications for therapy production. However, advancements in the CGT industry often outpace adjustments…
Driven by the urgency of the COVID-19 pandemic, the US government’s Operation Warp Speed (OWS) initiative gave biomanufacturing-facility design and construction teams an opportunity to unleash their creativity and put forth innovative solutions. Although the exigency for SARS-CoV-2 vaccines has declined, the life-science industry’s lightning-fast pandemic response has left a lasting impression among many companies. For instance, today’s biomanufacturers might wonder why facility construction should take four or five years when the industry has shown that it can be done…
It should come as no surprise that the pandemic instigated a boom in life-science facility construction around the world. Biotechnology facilities can be built from the ground up or converted from existing office, industrial, or older life-sciences sites. Choosing among those options is seldom straightforward. Thanks to strong academic institutions and well-entrenched industrial hubs, the top three US markets for life-sciences real estate continue to be Boston in Massachusetts and San Francisco and San Diego in California. Home to Harvard…