Author Archives: Cheryl Scott

Biopharmaceutical Characterization, Part 2: Applications and Strategies for Diverse Products — A Conference Report

Last fall, KNect365 brought together more than 250 analytical specialists to discuss biological assays and characterization of well-characterized biologics in Rockville, MD. Speakers from the US Food and Drug Administration joined experts from leading biopharmaceutical companies, service providers, and consultancies for case studies, regulatory interactions, sharing perspectives, and learning about emerging technologies. Part 1 of this report in January 2019 focused on the bioassay section of the meeting. Here in Part 2 sponsored by Sartorius, BPI’s senior technical editor reports…

Large-Scale Capacity Strategies: Single Use, Multiuse, or Both?

Early manufacturing facilities for large-scale production of biopharmaceuticals were, by necessity, very large. Low expression titers and blockbuster-market products such as monoclonal antibodies (MAbs) combined to require massive bioreactors — with capacities of 10,000– 20,000 L or more — and supporting infrastructure. In my early days covering the industry, I visited a few such facilities and was always awed by the huge tanks and what seemed like miles of piping. A 2010 Pharmaceutical Engineering article described a process modeling approach…

June 2019 – From the Editor

Often we are pleasantly surprised at thematic connections that fall within an issue or come between an issue and its supplements — sometimes planned, sometimes a matter of happy coincidence. Setting an issue theme of continuous processing with a featured report on large-scale capacity strategies inevitably created some overlap. At this stage of maturation in its brief history, the biopharmaceutical industry offers myriad choices for facility design, process development, manufacturing paradigms, and partnering arrangements. With many successful examples to choose…

Making Downstream Processing Continuous and Robust: A Virtual Roundtable

Current biomanufacturing is driven to pursue continuous processing for cost reduction and increased productivity, especially for monoclonal antibody (MAb) production and manufacturing. Although many technologies are now available and have been implemented in biodevelopment, implementation for large-scale production is still in its infancy. In a lively roundtable discussion at the BPI West conference in Santa Clara, CA (11 March 2019), participants touched on a number of important issues still to be resolved and technologies that are still in need of…

On Continuous Chromatography: A Conversation with Sanofi’s George Weeden

George S. Weeden, Jr., is a scientist in global manufacturing science and technology (MSAT) process science at Sanofi. We recently chatted about the topic of continuous chromatography. What are the general reasons for companies to consider continuous chromatography? And what are the caveats? The main driver for considering continuous chromatography is reducing the cost of goods (CoG). Continuous chromatography improves productivity (mass of product per volume of stationary phase over time) and thus increases throughput or decreases volumes of stationary…

Single-Use Technology in Upstream Processing: A Roundtable Discussion

The Sartorius upstream portfolio addresses key strategic challenges facing the biopharmaceutical industry: Increased speed to clinic/market and lowered capital costs, with improved process control. Fully scalable, proven process solutions for cell line, media, and process development through commercial manufacturing accelerate upstream development and simplify manufacturing. Novel high-throughput development tools for intensified processes incorporate the latest in process analytics, multivariate data analysis (MVDA), and design of experiments (DoE) software tools. These tools are designed to compress development timelines and to scale…

Building Toward Antibody–Drug Conjugate Success

“We are witnessing one of the most significant paradigm changes in oncology drug development, with some new types of immunooncology compounds inducing unprecedented increases in survival in certain solid and liquid tumor indications.” —Jagath Reddy Junutula (Cellerant Therapeutics) and Hans-Peter Gerber (Pfizer) (1) An antibody–drug conjugate (ADC) for cancer treatment needs four things to succeed clinically: It needs to target the right antigen using the right antibody, with the most powerful cytotoxin attached by best linker option. These features combine…

Antibody Derivatives: Deconstructing MAbs for the Next Wave of Biotherapies

Although they make up the largest and most successful category of biopharmaceuticals so far, monoclonal antibodies (MAbs) suffer from certain disadvantages. Some companies are addressing those limitations by deconstructing MAb molecules to create new emergent therapeutics. These antibody derivatives include: antibody fusions and fragments, bispecifics, trifunctional antibodies, and more. This eBook combines market analysis from consultant David Orchard-Webb with technical discussion from BPI cofounder and senior technical editor Cheryl Scott. It also includes commentary from editorial advisor Michiel Ultee and…

April From the Editor

Our focus on regenerative medicine this month, with its inherent personalized approach, brings to my mind aspects of “the patient experience.” Last week at BPI West in Santa Clara, CA, I was intensely moved by the performance of lymphoma survivor Toby Peach (www.tobypeach.co.uk). Our KNect365 colleagues will be asking him back this fall for the BPI Conference in Boston, and I encourage you not to miss him if you’re there. Many of us will be touched by some form of…

Monoclonal Antibodies: Beyond the Platform in Manufacturing

The vast majority of monoclonal antibody (MAb) production processes are based on fed-batch Chinese hamster ovary (CHO) cell culture and protein A affinity column chromatography capture. Increasing cost-consciousness — among innovator companies as well as biosimilar makers — has many companies looking “beyond the platform” for less expensive alternatives that may provide better results. Here the BPI editors review some state-of-the-art alternatives in upstream and downstream MAb drug substance bioprocessing as well as drug-product manufacturing. The current “gold standard” platform…