This week’s headlines include: CRISPR-Edited T Cells Used in Cancer Patients for the First Time in the US, FDA grants Sandoz approval for Ziextenzo in oncology care, Takeda opens €130M plant to produce dengue vaccine it has yet to get approved, Ebola vaccine approved in Europe in landmark moment in fight against a deadly disease, Why NIH is beefing up its data sharing rules after 16 years, WHO OKs Merck Ebola vaccine, paving way for stockpile, and WHO Seeks to Expand Access to Insulin With Prequalification Program.

Podcasts:

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

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…

Spheroid Culture Advancements – Microplates

While the benefits of 3D spheroids are clear, culturing them can be challenging and can give rise to the need for troubleshooting and questions. For this week’s Ask the Expert session, we are happy to have Hilary Sherman, Senior Scientist and Audrey Bergeron, Applications Scientist both with Corning Life Sciences to answer questions about culturing spheroids and the latest advancements including new plate options…

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…

Conferences:

Headlines:

“CRISPR-Edited T Cells Used in Cancer Patients for the First Time in the US,” The Scientist

“Preliminary research suggests that using CRISPR to treat cancer is safe in humans and could become a feasible therapeutic method in the future, although its efficacy is still unknown. Results from an ongoing clinical trial, led by hematologist Edward Stadtmauer of the University of Pennsylvania Perelman School of Medicine, will be presented at the American Society of Hematology meeting in December. ..”

“FDA grants Sandoz approval for Ziextenzo in oncology care,” PharmaTimes Online

“The US Food and Drug Administration (FDA) has approved Sandoz’ biosimilar Ziextenzo (pegfilgrastim-bmez). The biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo (pegfilgrastim) since 2018, and now Sandoz intends to launch Ziextenzo in the US as soon as possible this year…”

“Takeda opens €130M plant to produce dengue vaccine it has yet to get approved,” FiercePharma

“Takeda has yet to file for approval of its vaccine candidate to treat dengue, but it now has a  €130 million plant and 200 jobs relying on that nod. The Japanese company today said it has opened the plant Singen, Germany, which will handle formulation, fill, finish and secondary packaging of the dengue vaccine candidate, starting with the packaging line…”

“Ebola vaccine approved in Europe in landmark moment in fight against a deadly disease,” STAT

“After more than two decades of research, the world finally has an approved Ebola vaccine. The European Commission granted marketing authorization to Merck’s vaccine, known as Ervebo, on Monday, less than a month after the European Medicines Agency recommended it be licensed. It is currently being used in the Democratic Republic of the Congo under a “compassionate use” or research protocol similar to a clinical trial…”

“Why NIH is beefing up its data sharing rules after 16 years,” Science

“The U.S. National Institutes of Health last week released a draft policy that will require all investigators with NIH funding to make their data sets available to colleagues. For the first time, grantees holding any NIH-funded grant—not just those above a $500,000 threshold in direct costs—will need to submit a detailed plan for sharing data, including steps to protect the privacy of research subjects…”

“WHO OKs Merck Ebola vaccine, paving way for stockpile,” CIDRAP

“The World Health Organization (WHO) announced today that it has prequalified Merck’s Ebola vaccine, a move that comes just 1 day after the European Commission granted full approval for VSV-EBOV, which is in use on a compassionate basis and under further study in the current Ebola outbreak in the Democratic Republic of the Congo (DRC)…”

“WHO Seeks to Expand Access to Insulin With Prequalification Program,” Regulatory Focus

“As only about half of the 65 million people worldwide with Type 2 diabetes who need insulin can access it, the World Health Organization (WHO) on Wednesday announced the creation of the first prequalification program for insulin manufacturers…”