This week’s headlines include: Donors pledge $2.6 billion for ‘last mile’ of polio eradication, Eli Lilly Plans $400M Manufacturing Expansion, CDC updates ‘core’ antibiotic stewardship elements for hospitals, Top GOP senator: Drug pricing action unlikely before end of year, Rollout of Johnson & Johnson Ebola vaccine begins in Congo, and CRISPR Therapeutics, Vertex Report First Data from Trials of Gene-Editing Treatment CTX001.

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

Cool Tool – New BenchStable™ Media Provides Flexibility and Convenience While Helping the Planet

Researchers looking for reduced cold storage space requirements and easier access to media on their bench top, now have an answer. Recently launched Gibco™ BenchStable™ media are specifically engineered for room-temperature storage. This permits flexible media storage on the lab bench, thus freeing up valuable cold storage space…

Using 3D cell-based human liver microtissue models to predict adverse effects caused by chronic exposure to engineered nanomaterial

In this podcast and accompanying article, we interviewed Dr. Shareen Doak, Professor of Genotoxicology and Cancer at Swansea University Medical School and Dr. Wolfgang Moritz, Co-founder and Head of External Collaborations and IP, InSphero about the use of 3D cell-based human liver microtissue models to predict the adverse effects of chronic exposure to nanomaterial. We also discussed the use of liver microtissue models for drug discovery and developmen…

Using Organoids for Disease Modeling

The culture of organoids has permitted researchers access to a highly physiologically relevant system for studying human disease. Human organoids reflect key structural and functional properties of organs such as kidney, lung, gut, brain and retina making them incredibly valuable, particularly in situations where there is an unmet need for an in vitro human model. While their value is undeniable, culturing organoids can be quite challenging. Many tools and techniques have been developed for organoid culture, however depending on the cell type, research area and experimental goals, it can be difficult to identify the right method. For this Ask the Expert Session, we have assembled a team of experts to answer your questions on disease modeling using organoids…

Improving expression and purification of mAb using FectoCHO^® Expression System and MabXpure^™

Transient gene expression (TGE) is commonly used for medium scale production of recombinant proteins and antibodies in suspension CHO cell lines. This approach allows production of sufficient protein amounts for “proof of concept” studies or tools validation, prior to moving on to time-consuming, but cost-effective production of stable cell lines at large scale. Speed and flexibility of TGE has allowed this technique to be widely adopted in early phase discovery. There are two main bottlenecks in protein production that need to be addressed to make TGE profitable: increasing protein production yield and improving protein recovery yield…

Live Cell Analysis for Neuroscience Research

In this podcast, we talk with Susana Alcantara, Senior R&D Scientist and Neuroscience Program Leader, BioAnalytics, Sartorius about the ways real-time live cell analysis is enabling neuroscience research. We also discussed how real-time cell analysis can be used in neurological disease model development and in studying disease pathology to enable drug discovery…

Novel affinity resins enabling the purification of next generation antibody fragments: KANEKA KanCap™ G and KanCap™ L

Ever since the licensing of first monoclonal antibody (mAb) drug, biologics have seen unprecedented growth as drugs to treat a variety of malignancies¹. The modular structure of mAbs have allowed protein engineers to create smaller, nimbler, and multispecific next-generation antibody therapeutics. Some of these modalities can be easily produced using microbial expression systems, offering higher yields and excellent process economy²…

Supplier Qualification and Material Selection – A Case Study of Biopharmaceutical Resin Manufacture

To ensure a safe and continuous supply of life-saving biopharmaceuticals, raw materials for biomanufacturing must be selected carefully and suppliers evaluated with much scrutiny. Several instances of drug shortages as the result of either a raw material shortage or contamination reinforce the need for thorough evaluation. Ensuring a reliable supply and the quality of the materials selected is of paramount importance…

Bioburden Control Strategies for Continuous Downstream Processing

Implementing continuous bioprocessing for biomanufacturing has been increasing in interest. As a result, questions have arisen about the implementation of this strategy for downstream processes. Of particular interest is maintaining a high degree of bioburden control in continuous downstream process. While bioburden control strategies for continuous processing focus on prevention, not unlike batch processing, many want to know if there are specific strategies that should be implemented with continuous bioprocessing that are different than those used in batch processing…

Cool Tool – Innovative sorbents enable a robust and streamlined protein purification process

Monoclonal antibodies have long been purified using a platform approach. This platform mainly consists of three chromatography steps. These include a Protein A based affinity chromatography step followed by polishing steps. The purpose of the affinity chromatography is to capture the mAb, while the polishing steps remove any remaining impurities, such as residual DNA, host cell proteins, viruses and aggregates. There are options in the selected polishing steps, but often they involve cation exchange or hydrophobic interaction. Increasingly membrane chromatography is being used as a polishing step to remove any remaining contaminants…

Optimizing mAb Purification with Highly Selective Mixed-mode Cation Exchange Sorbent

In today’s market, mAbs are produced for several therapeutic applications, yet they are not a homogeneous family of products. Each mAb is unique, based on its isoelectric point, hydrophobicity and ability to aggregate; the contaminant HCP content is also process-dependent. As drug manufacturers seek to produce mAbs for various application, they are also looking to streamline processes for efficiency and quality…

Headlines:

“Donors pledge $2.6 billion for ‘last mile’ of polio eradication,” Reuters

“Donor governments and philanthropists pledged $2.6 billion on Tuesday to help fund a worldwide polio eradication plan that has taken decades to reach what global health specialists say is now the “last mile”. The funding – almost of half of which came in a single donation from the Bill & Melinda Gates Foundation – will be used to immunize 450 million children against polio each year, the World Health Organization (WHO) said in a statement…”

“Eli Lilly Plans $400M Manufacturing Expansion,” Genetic Engineering News

“Eli Lilly said today it will invest $400 million toward expanding its manufacturing capabilities at its Lilly Technology Center campus in Indianapolis, an initiative that is expected to add 100 jobs to the pharma giant’s workforce. The expansion, Lilly said, will include enhancements to existing manufacturing facilities that make insulin, additional capacity for its growing portfolio of diabetes medicines, and initial capital investments for future medicines…”

“CDC updates ‘core’ antibiotic stewardship elements for hospitals,” CIDRAP

“The Centers for Disease Control and Prevention (CDC) has released updated guidance to help optimize antibiotic use in US hospitals. The CDC says the new version of its Core Elements of Hospital Stewardship Programs, released late last week, reflects lessons learned by hospitals in the 5 years since the document was first published, along with evidence from the field of antibiotic stewardship. The 2019 update emphasizes the need for more commitment from hospital leadership, prioritizes specific antibiotic stewardship interventions, and calls for more efforts to educate patients about antibiotic use…”

“Top GOP senator: Drug pricing action unlikely before end of year,” The Hill

“Sen. John Thune (R-S.D.), the Senate’s No. 2 Republican, said Tuesday that it is unlikely the Senate will pass legislation to lower drug prices before the end of the year. “I think it would be the triumph of hope over experience to think that we could get it done before the end of the year, but there’s a lot of interest in doing something on drug pricing,” Thune told reporters on Tuesday…”

“Rollout of Johnson & Johnson Ebola vaccine begins in Congo,” Reuters

“Health authorities in eastern Congo have introduced a new Ebola vaccine produced by Johnson & Johnson, aid group MSF said on Thursday, to help combat the world’s second-worst outbreak of the virus on record.New tools including vaccines have helped contain the outbreak, second only to the 2013-16 West African outbreak that killed more than 11,300, despite public mistrust and conflict affecting the response in parts of the region…”

“CRISPR Therapeutics, Vertex Report First Data from Trials of Gene-Editing Treatment CTX001,” Genetic Engineering News

“CRISPR Therapeutics and Vertex Pharmaceuticals today reported preliminary, mostly-positive safety and efficacy data from the first two patients enrolled in two Phase I/II trials assessing their CRISPR/Cas9 gene-edited therapy CTX001 for a pair of blood disorders—the first clinical trial of a gene-editing candidate sponsored by U.S. companies…”