Economics

It’s All About Speed: Getting to Early Development Clinical Trials Quickly

David J. Kenyon, senior director of global scientific and technical affairs, Patheon (Thermo Fisher Scientific) Kenyon has over 25 years of experience in the pharmaceutical/biotechnology and vaccine industries. He began his career with Johnson and Johnson, where he managed the production of the first monoclonal antibody (MAb) approved for human therapy. He joined Patheon in 2014. Kenyon received his PhD from the Rutgers School of Medicine and Dentistry of New Jersey. Patheon is now part of Thermo Fisher Scientific. Thermo…

Using New Technologies to Compress Timelines, Increase Capacity, and Reduce Costs: Speed — Why, When, and How

Moderator Tom Ransohoff, with Jorg Thommes, Chris Love, Rajesh Beri, and Geoffrey Hodge For biopharmaceuticals to mature as a process industry, companies need to embrace the ability to adopt new technologies and bring new operational approaches to their biomanufacturing facilities. In this roundtable about adopting and implementing new technologies in the biologics industry, moderator Tom Ransohoff stressed the importance of understanding drivers for adopting new technologies and of developing enabling processes that factor in associated risks and challenges. He offered…

Capacity Strategies: The Strategies Behind Choosing Between Large-Scale and Single-Use Investments

Moderator Dan Stanton, with Weichang Zhou, Jenifer Wheat, Roger Lias, and Jim Vogel Single-use technologies (SUTs) are now prevalent within bioprocessing, but does this spell the end of industry’s historic reliance on stainless steel and fixed facilities? This roundtable was formed to discuss the wealth of investment in single-use (SU) equipment and flexible manufacturing solutions by contract development and manufacturing organizations (CDMOs) over the past few years, pitting that against what looks like a resurgence in fixed-cost stainless steel plants…

BioProcess Insider Interviews at the BPI Theater @ BIO 2018 – Mass Bio and Bioasis

At the BPI Theater @ BIO, editor Dan Stanton conducted a series of interviews live on stage to report on the latest movements in the biomanufacturing industry to start each busy day of dealmaking in Boston. Below are the videos from conversations with David Lucchino, chairman, Mass Bio; and Mark Day, president and chief executive officer, Bioasis. Massachusetts: Secrets to Success Lucchino explains that when you have a set of companies in an area, it lays the groundwork for growth…

Demand for Capacity Drives China’s Biomanufacturing Expansion

Over the past year, most of China’s biomanufacturing facilities have been engaged in active facility expansion. Based on our research of facilities under active construction, that growth has expanded total capacity in China by over 10%. Our research updates the Top 60 Biopharmaceutical Manufacturers in China directory from BioPlan Associates (1) and shows a continuing increase in new bioprocess capacity. This trend is unlikely to abate. As well as contacting our top 60 biomanufacturers, in fact, we contacted a number…

Statistical Properties of WECO Rule Combinations Through Simulations

The practice of quality control is promoted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). A number of process control charts are used in many biopharmaceutical companies to increase production and lower process costs. Here we focus on performance of three commonly used control charts: Shewhart control charts with WECO and supplementary rules, monitoring charts with exponentially weighted moving average (EWMA), and cumulative sum (CUSUM) charts. WECO rules got the name from a quality control…

eBook: SUStainability — Concerning Single-Use Systems and the Environment

Disposable materials have been used in many aspects of biomanufacturing since muromonab was first launched in 1986. Single-use stirred-tank bioreactors first became commercially available from HyClone in 2004 (1). Despite their demonstrated value to bioprocessing, disposable materials remain the subject of wide-ranging differences of opinion. Discussions of any technology are healthy and important for identifying areas for improvement, but some hearsay and bold propositions made regarding single-use components and the environment are not always helpful. Sustainability is an important and…

Cost Analysis of Cell Therapy Manufacture: Autologous Cell Therapies, Part 2

In part 2, we continue to analyze manufacturing costs of an autologous cell therapy. A typical process involves the expansion and activation of cells derived from a single patient, which is currently very labor-intensive. To date, there is little published information on overall production costs (1). In part 1, we used a software modeling platform to identify opportunities for potential cost savings. We developed a baseline model of a cell therapy manufacturing process using the production of autologous dendritic cells…

Your Brand Is the Patient’s Experience

The future success of biopharmaceutical businesses will depend at least partly on their ability to create meaningful brand experiences from the start of a drug program. By “brand,” I don’t mean logos and taglines. I’m talking about meaningfully unique experiences that directly affect clinical and patient needs — specifically, to address the growing demand for self-administered injectable therapeutics. Whether you are a biosimilar developer trying to carve out differentiated value or a market leader looking at your patent protection in…

Cost Analysis of Cell Therapy Manufacture: Autologous Cell Therapies, Part 1

Cell therapies are a growing area of interest for the treatment of a number of indications such as neurological, cardiovascular, and ophthalmological maladies that are refractory to other more conventional drug therapies. A number of cell-based therapy products currently are undergoing clinical trials. The most common target is oncology, which represents 46% of all cell-based therapies through the use of traditional blood-cell and immune-cell–based therapies. For treatment of various cancers, immune cells, lymphocytes (natural killer cells, T cells, and B…