
The Dish’s Weekly Biotechnology News Wrap Up – April 14, 2017
This week’s headlines include: FDA continues to approve most drugs faster than its European counterpart, Scotland first UK nation to routinely offer HIV PrEP, GE Healthcare Adds to Its Cell Therapy Portfolio by Acquiring Asymptote, Mesoblast takes off as Cell Therapy for heart failure passes interim test, Roche’s Alecensa notches trial win against Pfizer’s Xalkori, and FDA Delays eCTD Requirements for Master Files.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
GMP Proteins for Cell Therapy Manufacturing: Top 6 Things to Know
Using cells as a therapeutic offers one of the most promising new approaches for treating human disease. These methods include stem cell therapies and regenerative medicine, as well as immune cell therapies for cancers and immune-related disorders. Despite the promise, it has been difficult to bring these therapies mainstream. They are vastly more complex than traditional small molecule treatments or biotherapeutics. For example, in autologous therapies like CAR T, cells are removed from the patient, enriched for the cell of interest, genetically engineered to target the tumor, expanded in cell culture, and re-introduced into the patient as the therapeutic (Figure 1). Many of these steps have yet to be standardized and, along with the inherent variability in biological systems, there is increased potential for unanticipated results and risk to patients…Smart Cell Culture Monitoring – Transforming the way we look at cells in culture
In this podcast, we interviewed Philip Mathuis, Co-founder and CEO, Ovizio, about cell culture monitoring, the latest technology for monitoring cells in culture without the need for sampling and where monitoring could move in the future…A Primer on Primary Cells and Culture
Cell-based experiments play a key role in life science, biomedical and pharmaceutical research breakthroughs. The experiments and assays depend on a superior cell culture system and careful selection of cell types. Isolated directly from tissue, primary cells resemble normal physiology and lack modifications associated with immortalized, genetically-altered cell lines. They are first carefully removed and released from tissue, and then established as a growing, healthy cell population in a controlled culture environment. Properly isolated primary cells should be low passage and robust, with high viability, transfection efficiency and doublings. After isolation, the cells can then be expanded, frozen, documented and tested. Researchers can select from many unique human and animal cell types, available in various sizes and packaging configurations, including freshly isolated, cultured, proliferating or cryopreserved cells. Frozen vials, microwell plates, flasks or easy-to-use total kits provide further options. Tissues and cells can also be isolated in matched sets from the same donor…The Importance of Resin Selection in Development of a Platform Bioprocess Film
Utilizing single-use technologies for biomanufacturing is growing due to several operational benefits including; reduced cleaning and validation, decreased water usage, lower initial capital investment, increased manufacturing flexibility, and faster turnaround time between runs. As the implementation of single-use products has grown, so too has the expectation for improved performance and an increase in the number of application areas involved. Issues have arisen with respect to container integrity, bag flexibility and extractable/leachable profiles. For example, end users want to see single-use products provide the strength needed to maintain container integrity, while at the same time provide the flexibility required for use in applications like bulk liquid transfer and rocking bioreactors. In addition, it is critical that the single-use products do not leach any compounds into the culture that would have a negative impact on the cells or the final product…Job Outlook for the Biomanufacturing Industry
In this podcast, we interviewed Hillary Kaplan, Director, Bioprocess CMC Development & Operations, Klein Hersh about the job outlook for the biomanufacturing industry from a recruiter’s perspective…Cool Tool – Scale up with confidence – Introducing ReadyToProcess™ 32 L (450/200)
To reduce costs, increase flexibility and shorten time to market, the use of single use and disposable technologies have increased significantly in biopharmaceutical development and manufacturing. In downstream processing prepacked chromatography columns reduce the need for time consuming cleaning validation and column packing. The last few years has seen a steadily increasing implementation of prepacked chromatography columns in process development and clinical manufacturing. Many of these projects are now scaling up for commercial production…Fortem: A platform film built for bioprocess
The increase in adoption of single-use bags for manufacturing biopharmaceuticals has been driven by the many advantages it offers. However, the materials of construction can be more complex than conventional stainless steel vessels. Single-use containers are constructed from plastic films, which are often composed of several layers of polymers with additives for processing and performance…Cool Tool – New KANEKA KanCapA™ 3G for Improved Binding and Milder Elution of Therapeutic Antibodies
Protein A is by far the most common purification method in biopharmaceutical manufacturing. Due to its high affinity and selectivity for therapeutic antibodies, high purity can often be reached in a single step. With the expanding market for therapeutic antibodies, pressure to reduce the cost of pharmaceuticals, and increases in upstream production titers; Protein A improvements have been required to meet industry demands for improved downstream purification efficiency…
Webinars:
Design, Characterization, and Scale-Up Strategy for a New Single-Use Production-Scale Bioreactor – April 27th 11:00 EST
The design of the initial range of single-use stirred bioreactors was cylindrical, essentially copying that of traditional stainless steel bioreactors. The cylindrical shape with dished ends was intended to minimize the expensive steel stainless wall thickness and still be strong enough to withstand the internal pressure developed during steam sterilization. However, since single-use biocontainers can be supplied presterilized, novel shapes can now be considered. Indeed a square cross-section design demonstrates some significant advantages over a cylindrical one. This GEN webinar will first introduce and discuss the engineering concepts of the Allegro™ STR bioreactors, a square bioreactor design with volumes of 200 L, 1000 L, and 2000 L, and then utilize these concepts to demonstrate scale-up from the bench with a live culture. Who Should Attend- Upstream bioprocessing engineers
- Upstream process development scientists
- Clinical and commercial manufacturing supervisors and technicians
- QA/QC scientists
- Why a square cross-section brings significant advantages to the upstream process, for handling, process assurance, while maintaining optimal cell culture performance
- About the performance of a square-shaped bioreactor, in terms of mixing efficiency, mass transfer of oxygen (kLa), and CO2 stripping
- Applying system engineering principles toward bioreactor characterization, and how tech transfer methods are leveraged across designs, from the bench to production vessels