This week’s headlines include: U.S. continues to lead the fight against antibiotic resistance, FDA Debates Creating Pilot to Evaluate Novel Excipients, Novartis CEO plans 80+ submissions for drug approvals through 2022, J&J launches biologic protein spray for sealing off bleeds during surgery, New typhoid fever vaccine protects young children, and U.S. considers easing drug protection to break deadlock over trade pact: Wall Street Journal.

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

Intelligent Lentivirus Analysis – Coupling an Automated Imaging System with Artificial Intelligence

The number of gene and cell therapies in the clinic is increasing rapidly. With the increase in gene therapy manufacturing, comes the need for improved analytics during the production process. Analytics for Lentivirus production is particularly important as it is currently the second most common vector used in cell and gene therapy manufacturing…

New Technologies to Facilitate 3D Bioprinting of Transplantable Organs

Broadly, the term “3D printing” refers to processes where a computer model of an object is recreated using materials are deposited and fused (such as polymer liquid or powder granules solidified together), layer by layer, to create a three-dimensional object. It is not surprising that this simple premise sparked innovation in other fields such as biomedical research. In this iteration, known as 3D bio-printing, living cells are deposited layer by layer in combination with biological scaffolds to form a desired 3D organic structure. While the spirit is the same as conventional 3D printing, bio-printing is considerably more complex because the functionality of tissues and organs is not solely based on physical structure. There are key interactions with other cells as well as their microenvironment, which inform their tissue-specific role. Nevertheless, this technique can be leveraged to fabricate complex, functional, cellular structures for many applications, including basic research, personalized medicine (disease modeling), regenerative medicine (transplantation or prosthetics) therapeutic investigation (drug screening/development) and for use in bioassays (cosmetics testing)…

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…

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:

“U.S. continues to lead the fight against antibiotic resistance,” STAT

“One of the greatest threats to public health today, in the United States and around the world, isn’t a new exotic hazard. It’s antibiotic resistance: the potential failure of one of our most important and well-known disease-fighting tools. The latest Antibiotic Resistance Threats Report, recently published by the Centers for Disease Control and Prevention, shows that antibiotic-resistant (AR) infections — when germs defeat the drugs designed to kill them — cause more than 35,000 deaths each year in the United States…”

“FDA Debates Creating Pilot to Evaluate Novel Excipients,” Regulatory Focus

“The US Food and Drug Administration (FDA) on Wednesday sought comments on whether it should run a voluntary pilot program to evaluate the toxicology and quality of novel excipients. While the agency does currently review new excipients as part of an investigational new drug application (IND) or a marketing application (NDA or BLA), FDA explains how certain novel excipients may provide public health benefits, such as improved drug delivery or utility in abuse-deterrent opioid formulations…”

“Novartis CEO plans 80+ submissions for drug approvals through 2022,” Reuters

“Novartis is planning more than 80 major submissions to regulators for drug approvals from 2020-2022 in the United States, Europe, Japan and China, Chief Executive Vas Narasimhan said on Thursday ahead of a meeting with analysts and investors. The submission figure is up from the 60 that the Basel-based company had said it was planning for the 2019-2021 period. It reiterated prospects of more than 25 potential medicines in its pipeline that could eventually top $1 billion in sales…”

“J&J launches biologic protein spray for sealing off bleeds during surgery,” FierceBiotech

“Johnson & Johnson’s Ethicon unit has launched its blood-stopping protein spray, designed to quickly seal off and control excessive bleeding during open surgeries or minimally invasive procedures. It’s the first product to graduate from the devicemaker’s collaboration with the plasma-focused Spanish multinational, Grifols. The Vistaseal biological sealant combines human fibrinogen and thrombin, two clotting agents found in the bloodstream…”

“New typhoid fever vaccine protects young children,” Reuters

“The first field trial of a new typhoid vaccine that can be used in young children provides protection for 81.6% of recipients, opening the door to better control of a disease that affects 11 million people each year and kills roughly 117,000. The test in Nepal “provides the first evidence of the level of impact and the potential for improving the health of children in some of these very vulnerable populations around the world,” lead author Andrew Pollard of Oxford University in the UK told Reuters Health in a telephone interview…”

“U.S. considers easing drug protection to break deadlock over trade pact: Wall Street Journal,” Reuters

“The Trump administration is considering scaling back intellectual-property protections for biologic drugs by big drugmakers to help win Democratic support for a new trade pact with Mexico and Canada, the Wall Street Journal reported, citing people familiar with the matter…”