This week’s headlines include: Gene Therapy Hits a Peculiar Roadblock: A Virus Shortage, Takeda pushes U.S.-backed Zika vaccine into the clinic, GE Healthcare Acquires UK’s Puridify, GSK, MMV submit malaria drug in the US, FDA backs Roche’s Gazyva in first-line follicular lymphoma, and bluebird bio Acquires Durham, NC, Manufacturing Site for Lentiviral Vector Production.

In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:

Ask the Expert – Enabling Stem Cell Therapy Biomanufacturing using Dissolvable Microcarriers

Cell culture on microcarriers is an increasingly important technique for the production of large cell quantities and the scale-up of Cell Therapy applications. Microcarriers—small, spherical beads used to grow adherent cells in a suspension culture—offer several advantages for large-scale cell culture: Because they are suspended, microcarriers allow for a maximized surface area-to-volume ratio. Single-vessel conditions make microcarriers amenable to scale-up applications. Microcarriers also offer the ability to monitor and control physiological conditions when used in bioreactors…

Organoid Cell Culture – Frequently Asked Questions

We recently finished our Ask the Expert discussion, “Going tiny is the next BIG thing: Tools and Techniques for Organoid Cultures”. During this Ask the Expert session, we covered topics related to the culture of organoids including, media requirements, co-culture with other cells, surface requirements, culture vessels, nutrient delivery and gas exchange, harvesting organoids, and key points on the cell culture process timeline. In addition, we also had questions about making organoid cell culture more high throughput to meet the needs of drug screening, the difference between spheroids and organoids, and best practices for immunostaining of organoids…

Video – Upstream Bioprocessing Cell Culture Overview

An overview of upstream bioprocessing steps beginning with an explanation of molecular biology and cell line engineering, then continuing with creation of a working cell bank, cell expansion, bioreactor production and clarification steps…

FBS – It’s not all created equal – what consumers need to know

In this podcast and accompanying article, we interviewed Alyssa Master, Ph.D., Senior Manager of Science and Applications, Nucleus Biologics about some of the challenges of working with FBS, why not all FBS is created equal and suggestions for FBS customers who are trying to navigate these issues…

Resolving large scale buffer management challenges

In this podcast and accompanying article, we interviewed Joakim Lundvist, Modality Manager, BioProcess™ Hardware, GE Healthcare about large-scale buffer management challenges. Buffer preparation is known to be one of the most resource-intensive activities in biomanufacturing as large volumes of buffers and process liquids are often required. So how can this be done in a more efficient way? How can more capacity be added to buffer preparation without adding major capital investment? Are there ways to reduce the manufacturing footprint and time spent on buffers?…

Enabling Antibody-drug conjugate manufacturing using single-use systems in downstream – Extractables study demonstrates a good fit

Antibody drug conjugates offer tremendous therapeutic potential and the market for ADCs is expected to expand rapidly. However, antibody-drug conjugate manufacturing presents both technological and logistical challenges…

2017 Biotech Week Boston – Downstream Coverage Highlights

Last month, Boston Biotech Week featured interesting content with a wide range of issues, from cell culture techniques to commercialization and everything in between covered. Talks focused on improving the manufacturing process for biopharmaceuticals and cell therapies, enabled industry networking opportunities, and provided the chance to see the latest products and technologies…

Cool Tool – Optimize downstream processing with single-pass inline concentration

Concentration of biological drug substances is an important step at various stages in biomanufacturing. Concentration is often necessary between chromatography steps, in post harvest, during pre-capture or for in-process volume reduction. Concentration may also be needed between chromatography steps.

During concentration applications, there is a potential for aggregation, particularly with sensitive biologics even when they are only slightly stressed. Therefore, an effective concentration system must operate efficiently under mild conditions while at the same time being flexible enough to integrate readily with different downstream operations…

Webinars:

Improving NK Cell-based Cancer Immunotherapy via mRNA Electroporation

December 13, 2017 – 11:00 am EST

Natural Killer (NK) cells are cytotoxic lymphocytes that can kill tumor-transformed and infected cells. In contrast to T cells, genetic engineering of NK cells using viral vectors has only recently started to show sufficient efficacy. Currently, viral approaches are associated with high costs and excessive regulatory work-load if used in the clinic. Genetic engineering of NK cells via mRNA electroporation has instead shown to be more efficient than viral transduction and is likely associated with less regulatory work-load for clinical realization. This webinar will focus on the current developments of mRNA electroporation of NK cells, including its efficacy and impact on cellular viability, proliferation, receptor expression and baseline cytotoxicity. Examples will be discussed for how mRNA electroporation can be used to modulate multiple properties of NK cells and thereby potentially further improve the outcome of cancer patients treated with NK cell-based immunotherapies in the future. Register Now!

Headlines:

“Gene Therapy Hits a Peculiar Roadblock: A Virus Shortage,” The New York Times

“Eager to speed development of revolutionary treatments, the Food and Drug Administration recently announced that it would expedite approval of experimental gene therapies. But the regulatory process may not be the biggest obstacle here…”