Cell Therapies

Biopharmaceutical Characterization,
Part 1: Biological Assays —
A Conference Report

In late October 2018, KNect365 brought together more than 250 analytical specialists to discuss 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, including BPI editorial advisor Nadine Ritter (president and analytical advisor of Global Biotech Experts). She began the final day moderating a special town-hall session where audience members could pose their regulatory questions to a panel of FDA reviewers, and she ended…

Standardizing Human MSCs As Critical Raw Materials in Cell Therapy Products: Streamlining Clinical Translation

Advancements in cell therapy, biofabrication, and synthetic biology have driven the growth of the global regenerative medicine (RegenMed) industry in the past decade. The industry has developed innovative treatment options for patients with otherwise unmet medical needs (1). Human or animal cells or tissues are used as critical raw materials in cell therapy products that can replace, regenerate, or augment patients’ diseased, dysfunctional, or injured cells, tissues, or organs. These cells or tissues can be unmanipulated, or their biological characteristics…

The Need for Adherent Cell Manufacturing: Production Platform and Media Strategies Drive Cell Production Economics

Most commercial biopharmaceuticals originated from academic research laboratories and start-up development laboratories. Despite such products having differences in modalities and targeted disease indications, and whether their target patient populations are relatively small or approaching blockbuster status, at a key point in development, biopharmaceutical production must scale up from laboratory to commercial production. That movement from research to development and then to manufacturing forces attention on economics and speed to market, and it drives innovative approaches to producing biopharmaceutical cell compositions…

Cell Culture Media: An Active Pharmaceutical Ingredient or Ancillary Material?

Cell-based therapies are used to treat diseases that require the replacement of diseased, dysfunctional, and injured cells (1). To produce these therapies, a wide range of reagents and materials such as antibodies, growth factors, and enzymes are used in their manufacturing processes. Such necessary materials are administered through a cell culture medium. Active pharmaceutical ingredients (APIs) are the main ingredients that make products therapeutic. Ancillary materials (AMs) and raw materials (RMs) are essential components used during production but are not…

eBook: Scalable Cell-Based Immunotherapy Manufacture: A Comparison of Single-Use Agitated and Static Expansion Technologies

Early clinical results indicate that personalized autologous immunotherapies could revolutionize cancer treatment (1). However, challenges lie in the realization of cost-driven, scalable cell therapy (CT) manufacturing strategies (2) for generating sufficient therapies to treat a populace, thereby limiting their translation to public health (3). Primary challenges involve complex needle-to-needle logistics, complexities in closed processing, and high variability in starting cell materials that define the autologous nature of such therapies. Despite barriers in industrial-scale manufacture, public health management already has engaged…

The Effect of Albumin on Viability in Stem Cell Therapy

Stem cell therapies are some of the most cutting-edge and sophisticated therapeutic developments. They offer an attractive alternative approach to more widely used treatments for conditions such as multiple sclerosis, metabolic diseases, cardiovascular disease, liver disease, and cancer. But developers still face challenges, some of which can be addressed by the use of recombinant human albumin. As a long-established ingredient of cell culture media, albumin is well recognized for its ability to facilitate growth of many cell types. The industry is expanding its use of high-quality, fully recombinant, current good manufacturing practice…

Accelerated Development, Manufacturing and Monitoring of Viral Vectors

The goals of process intensification are to enhance production while shortening timelines, lessening contamination and environmental risks to products and operators, and reducing operating footprints. Previous publications from Sartorius Stedim Biotech (SSB) have highlighted key elements of such activities. In this report, the authors extend the scope of this discussion to tools and technologies that enable intensification of viral vector manufacturing processes. The first article summarizes presentations from a 2018 seminar for viral vaccine manufacturers. Three guest presentations highlighted the…

Manufacturing Automation for Patient-Scale Cell Therapies

Nina Bauer, associate director of autologous cell therapy commercial development, Lonza Pharma and Biotech Lonza Emerging Technologies is focusing on cell and gene therapies. Lonza now has expertise in different cell and vector types, constructs, process and assay development, and platform technologies for both clinical and commercial manufacturing. This includes taking a concept through commercial manufacturing. Lonza just opened a site in Houston, TX, and another in the Netherlands, as well as partnering with Nikon in the Asian market. Cell…

Acoustic Cell Processing: An Innovation in Cell-Therapy Manufacturing

Richard Grant, chief product officer, FloDesign FloDesign is experimenting with applications of acoustics to cell-therapy manufacturing. An electric transducer is attached to a closed-flow system and generates forward propagating waves that are reflected as backward propagating waves. This sets up three-dimensional standing waves within the cell (flow) chamber. When cells enter the flow channel, acoustic forces cause then to cluster within the nodes of those standing waves, ultimately settling out through enhanced gravitational means. Acoustic cell processing is scalable and…

Feeding the Demand for Cell and Gene Therapy Production

Moderator Dan Stanton, with Ohad Karnieli, Alan Moore, and David Brindley Moderator Dan Stanton introduced the second roundtable of Tuesday morning by commenting on the recent spate of approvals for CAR-T cell and gene therapies. With large biopharmaceutical and biotechnology companies devoting scientists and funds toward these next-generation therapies, contract manufacturing organizations (CMOs) also are investing in opportunities to expand capacity and expertise. As the panelists introduced themselves, they raised two key points for discussion: The contracting model for advanced…