Upstream Processing

Single-Use Technology and Modular Construction

To enable broad, global access to life-saving biopharmaceutical products, our industry is facing significant pressure to reduce the overall cost of manufacturing and enable local manufacturing where possible. Combined with growing markets outside the United States and Europe and development of high-titer, high-yield processes, that pressure has led to a shift in the industry’s approach to facility design and construction. Today’s biopharmaceutical production facilities must be flexible, cost effective, and readily constructed with minimal capital investment and construction timelines. As…

Supporting Continuous Processing with Advanced Single-Use Technologies

It has been 10 years since the US Food and Drug Administration (FDA) articulated — in its guidance for process analytical technology (PAT) — the goal of “facilitating continuous processing to improve efficiency and manage variability” (1). Since that time, regulators and industry have worked toward applying continuous processing (CP) to all facets of pharmaceutical manufacturing, including bioproduction (2, 3). Last year, the European Medicines Agency (EMA) referred to CP in its draft Guideline on Process Validation, and the FDA…

A Short History of Cell Culture Media and the Use of Insulin

A surprising history of cell culture media and the use of insulin, outlining the basic developments behind growing mammalian cells.

It will take you on a journey from the late 1800 where organ tissues were kept in balanced salt solutions -BSS- and later PBS, until the early 50’s synthetic media, over chick embryo extract and Eagle’s Minimal Essential Medium (MEM) or its modification by Dulbecco (DMEM). Finally describing insulin mimicking growth factors.

Gram Scale Antibody Production Using CHO Cell Transient Gene Expression (TGE) via Flow Electroporation

MaxCyte flow electroporation provides a universal means of fully scalable, highly efficient CHO-based TGE for the rapid production of gram to multi-gram level s of antibodies without the need for specialized reagents, expression vectors, or engineered CHO cell lines. In this technical note, we present data demonstrating the reproducibility, scalability, and antibody production capabilities of MaxCyte electroporation. Secreted antibody titers routinely exceed 400 mg/L and can exceed 1gram/L following optimization, thereby enabling multi-gram antibody production from a single, CHO cell transfection. In addition, we present data showing the use of MaxCyte electroporation for the rapid generation of high-yield stable CHO cell lines to bridge the gap between early and late stage antibody development activities.

Has Your Current LIMS Implementation Been a Nightmare?

Because current traditional LIMS have not delivered on their promise, many organizations are still searching for solutions to optimize their laboratory operations. For those engaged in deploying traditional LIMS, frequent sleep-disturbing issues include poor flexibility and configurability, expensive and time-consuming customization, difficulties extending and upgrading systems, poor usability, lack of modular functionality, poor service/support, problems integrating with existing instrumentation/IT systems and extra time and resources required to meet critical qualification/compliance requirements. Learn how you can avoid the top 5 LIMS nightmares and rest easier with today’s next-generation process and execution-centric LIMS.

Characterization of Human Mesenchymal Stem Cells

Human mesenchymal stem cells (hMSCs) are a self-renewing population of adherent, multipotent progenitor cells that can differentiate into several lineages. The current definition of MSCs includes adherence to standard tissue culture plastic ware, expression of various surface antigens, and multilineage in vitro differentiation potential (osteogenic, chondrogenic, and adipogenic). hMSCs hold great promise as therapeutic agents because of their potential ability to replace damaged tissue and their immunomodulatory properties. Consequently, many clinical trials using hMSCs are currently under way in a…

A Statistical Approach to Expanding Production Capacity

Contract manufacturer DSM Biologics — at its current good manufacturing practices (CGMP) facility in Groningen, The Netherlands — provides services for clinical development and commercial production based on mammalian cell culture technology (Photo 1). During the 2011–2012 year, the facility went through a major expansion project to enlarge its capacity and fulfill a growing customer demand. From a business point of view, the project had a well-defined target for future production capacity as well as investment volume. Photo 1: Photo…

Advocating an Evolution

In a 2006 report, the US Department of Health and Human Services hailed regenerative medicine as “the vanguard of 21st century healthcare” and “the first truly interdisciplinary field that utilizes and brings together nearly every field in science” (1). To fuel support for regulatory, legislative, and reimbursement initiatives in this new therapeutic class, a small group of scientists, life science business executives, patient advocates, and other experts formed the Alliance for Regenerative Medicine (ARM, http://alliancerm.org). Starting with 17 charter members,…

2012 in Review

As children growing up, we could barely contain our anticipation for those banner, milestone years: entering first grade, becoming a teenager, turning 16 and then 18, high-school graduation. But even the most innocuous “in-between” years saw notable change and maturation, and 2012 was just such a year for the growing cell therapy sector. Although it is not likely to be noted as a pivotal or breakthrough year, 2012 nonetheless delivered some significant and welcome signposts of continued sector maturation. Here…

Single-Use Technologies in Cell Therapy

Single-use technologies (SUTs) are tools that can be used in producing cell therapies and personalized medicines. Such products must meet specific requirements because of the way they are used. To meet those criteria, the cell therapy industry simply has no alternatives to single-use systems. SUT applications are rapidly changing. Traditional uses for single-use systems in cell therapy include processing in clinical settings (e.g., blood bags, transfer sets) and research and development (e.g., T-flasks, pipettes). Although such applications continue, the commercialization…