This week’s headlines include: WHO eyes decision on monkeypox ’emergency’, Experts endorse Moderna COVID-19 shots for kids ages 6 to 17, Novartis, Precision Ink Deal to Develop Potential Sickle Cell Cure, BioNTech’s solid tumor CAR-T hits prime time with EU regulatory tag, US boosts monkeypox testing, 142 cases confirmed, Merck Wins Key FDA Approval for Pediatric Pneumococcal Vaccine, and Moderna to build new vaccine facility in Britain.

Upcoming Conferences:

Save the Date! 2022 Virtual 3D Cell Culture Summit on June 30, 2022

3D cell culture is exploding. To capture the energy and excitement of this moment in research, Corning is bringing together industry leaders and innovators for a global virtual 3D Cell Culture Summit to share ideas and information, and to discuss the future of 3D applications, including spheroid, organoid and tissue models. Join industry leaders and key influencers for this can’t miss life sciences event.

This is a free event hosted by Corning Life Sciences. To register, please visit: https://cvent.me/58Wa1L

Podcasts:

Check out our podcast channel. We have over 50 great podcasts covering drug discovery, stem cell culture, upstream and downstream biomanufacturing and more! Click below to download from iTunes or Google play:

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

Implementation of the Sartorius Octet® BLI Platform Accelerates Early Antibody Discovery Workflows

Therapeutic monoclonal antibodies (mAbs) are a predominant class of new drugs directed against an array of target antigens used to treat cancers and immunologic diseases. The discovery process for antibody-based drug candidates includes several steps from target ID and validation, hit identification to preclinical lead candidate selection prior to clinical trial testing to evaluate efficacy and safety. On average, development time for an antibody drug candidate can take 12–15 years and cost more than $1 billion. Solutions are needed to increase the efficiency and throughput of the screening, characterization and target identification in early antibody discovery to drive down costs and development time…

Predictive forecast model strategy to enhance process control and refine feeding strategy of essential amino acid in CHO cell cultures

Chinese Hamster Ovary (CHO) cells are an invaluable cell line for robust and reliable production of therapeutic proteins in the biopharmaceutical industry. There is significant pressure on the industry to accelerate process development to increase productivity and economics, but conventional empirical strategies, which are time-consuming and labor-intensive, are not well-suited to meet the growing demand for biologics and requirements to lower the cost of goods sold. Recent advances in -omics technologies, such as genomics, transcriptomics, proteomics, and metabolomics, that effectively link the genotype to the phenotype of an organism has greatly increased our understanding of CHO cells at a cellular level. Genome-scale models of CHO metabolism can be used for guiding effective process optimization, CHO cell engineering efforts, and bioreactor monitoring and control…

Using End-to-End Integrated Solutions to meet the High Demand for Viral Vector GMP Manufacturing

Animal cell culture is a central process for successful bioproduction of therapeutic proteins, viral vectors (for vaccines and gene therapies) and therapeutic cells (for cell-based therapies), which help prevent, treat and cure human disease. Optimized cellular nutrition is the key to unlocking cost-effective, highly efficient bioprocesses. Amino acids are essential nutrients and critical ingredients in cell culture media required for in vitro cell survival and proliferation because of their role as building blocks for proteins. Standard practice in biopharma is to add free amino acids to media formulations based on the nutritional requirements of the cell type of interest. However, the stability and solubility of certain free amino acids have quickly become limiting factors to higher productivity requirements as part of industrialized biomanufacturing (i.e., fed-batch or perfusion culture). Optimal media composition with the best ingredients at the right concentration helps drive productivity gains, streamline workflows, and reduce operating costs…

Gibco Cell Culture Basics Virtual Lab – A Great Example of the Benefits of Digital Training

Digital training tools are being popularized in the life sciences because of their accessibility, flexibility, and ability to foster learning across different competency levels and potentially in different geographical locations. The Gibco Cell Culture Basics Virtual Lab is a great example of this. Over the years, it has been a valuable resource for those new to cell culture or those seeking to improve their baseline skills. Due to popular demand, Gibco has recently re-launched the virtual lab with improvements and new features. The “renovated” lab builds on the original framework, offering scientists information on a wide range of cell culture topics and interactive activities within a virtual lab…

Extracellular Vesicles in Gene Therapy at this year’s ASGCT

The American Society of Gene and Cell Therapy (ASGCT) celebrated its 25^th year at their annual meeting at the Walter E. Washington Convention Center in Washington, DC last week and a full agenda is available on their site [ 1 ]. Originally designed for academic researchers to share their work, the annual meeting has grown to serve clinicians, bio-industry development, regulatory agencies, equipment manufacturers, patient advocates, and more. A truly remarkable number of activities and topics were addressed in the 4-day meeting. But from the scientific symposia and education sessions to the industry sponsored symposia and technology forums, it is really impossible to even begin to describe the topics and activities offered. There were over 6000 attendees participating in an excess of 80 unique sessions, covering many distinct cell gene technologies and addressing over 15 tissues, organs, and disease indications…

Single-Use in Biotech – Addressing Opportunities and Challenges

Over the past decade, the growth and adoption of single-use technologies in biomanufacturing has been steep and sustained. What began primarily with single use bioreactors has expanded to include single-use components from early upstream processes through downstream and into commercial manufacturing. As of 2018, single-use systems were being used for about 85% of preclinical and clinical biomanufacturing and are increasingly being incorporated into commercial manufacturing¹. The benefits of single-use technologies have been well documented and include risk mitigation, increased efficiency, reduced personnel requirements, less validation time, and customizable solutions. The technology has also been found to reduce utility and water costs for cleaning and sterilization, as well as lower batch changeover time. This is particularly important for facilities that run smaller manufacturing lots, with several different products or are looking to maximize facility flexibility…

Full Adeno Associated Virus (AAV) Capsid Enrichment Using Mustang® Q Membrane

Adeno-associated virus (AAV) vectors are becoming increasingly important gene delivery platforms for the development of gene therapies for several reasons. They are relatively safe with low immunogenicity, and demonstrate high gene transfer efficiency and stable long-term expression in both dividing and quiescent cells. As well, a number of AAV serotypes exist that differ in their tissue tropism, or the types of cells they infect, making AAV a very useful system for transducing specific cell types. Typically, AAV production occurs within a packaging cell line, such as HEK293T cells, where plasmid containing the gene of interest (GOI) are assembled into a protein capsid shell. A current challenge in manufacturing is that the encapsidation efficiency for AAV is highly variable, which produces a heterogeneous mixture of AAV particles that contain the GOI (full) and particles without any genome (empty) or with fragmented, non-functional DNA (partial). Because only the full AAV capsids can exert a therapeutic effect in vivo, the other capsids are viewed as a process impurity and removing them is a necessary step in downstream purification process to achieve a consistent drug product. Existing methods to purify full AAV capsids like analytical ultracentrifugation (AUC) are effective yet have limitations in throughput and cost for a manufacturing environment, which has driven the development of more scalable methodologies for AAV purification…

Single-use Mixers – Ensuring the Customization, Scalability and Supply Required for Success

In this podcast, we talked with Dennis Hodgson and Phil Sanders from Agilitech about the benefits of single-use mixers, dealing with supply chain concerns, ensuring scalability, and tailoring a mixer to meet specific process needs…

Increasing Liquid Chromatography Efficiency with Fully-controlled Binary Blending

In this podcast, we spoke with Cory Hinz, Engineering Manager at Asahi Kasei Bioprocess about the different methods that are available for liquid chromatography mobile phase solutions and the benefits of inline blending. Cory also describes how to implement binary blending feeding of a liquid chromatography process using inline blending…

Agilitech Single-Use Tangential Flow Filtration (TFF) System for Biologics Manufacturing – A Case Study

Manufacturers in the biopharmaceutical industry are facing ever-expanding pipelines and the pressures to increase productivity and long-term sustainability while also rising to meet the challenges of new products with specialized processing requirements. This has led to increasing adoption of single use equipment into manufacturing workflows over traditional stainless-steel systems. While single use technology (SUT) designs have advanced for processes in both upstream and downstream unit operations, there are limitations to how tailored these units can be to fit the needs of a specific production process. Manufacturers are often required to adapt their process to what is commercially available resulting in technology solutions that may be suboptimal or unsustainable to meet future product demand. Those seeking more customization to a find ‘better fit’ are faced with piecemealing different components from different vendors into a contiguous system to achieve their production goals. Better engineering solutions are needed to create fit-for-purpose systems from the beginning that are cost-effective and scalable rather than the industry practice of reconfiguring standard systems. Addressing these gaps in process design requires thorough understanding of bioprocess requirements and equipment capabilities to build efficient processes to meet current production needs and ensure readiness to support future product growth…

White Paper:

Cell and Gene Therapy Catapult and Advanced Instruments collaborated on a project to see how modulating osmolality in the early stages of AAV upstream manufacturing can result in improved outcomes such as overall yield, quality, reduced manufacturing costs, and improved efficiencies. Download the paper now at Improving Titer, Quality and Efficiency of AAV Manufacturing and Production by Optimizing Osmolality.

Headlines:

“WHO eyes decision on monkeypox ’emergency’, Africa says it’s long overdue,” Reuters

The World Health Organization will decide on Thursday whether to declare monkeypox a global health emergency, stirring criticism from leading African scientists who say it has been a crisis in their region for years…