The Dish’s Weekly Biotechnology News Wrap Up – May 27, 2022
This week’s headlines include: Pfizer to offer low-cost medicines, vaccines to poor nations, U.S. health officials releasing some Jynneos vaccine doses for monkeypox -CDC, Pfizer says third Covid vaccine shot for kids under 5 is 80% effective against omicron, Regeneron’s Evinacumab Fights Ultra-Rare Form of High Cholesterol in Kids, Precision BioSciences makes case for 2 gene editing programs over CRISPR with preclinical data, CureVac and myNEO will Leverage mRNA Learnings for Cancer Vaccines, and Moderna tunes vaccine platform to next potential viral threat: monkeypox.
Upcoming Conferences:
World Biopharm Forum 2022 – University of Oxford, UK – June 22-24, 2022
World Biopharm Forum 2022 is preparing for their upcoming conference Value Through Intensified Process II to be held at Lady Margaret Hall, University of Oxford, UK on June 22nd – 24th, 2022. It will provide introductions, reviews, and a few case studies of exciting advances in the materials, equipment, technology and processes supporting bioprocess intensification.
https://www.subramanian.org.uk
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:
Increasing Single-Use Technology Operator Competency with New Training Methods
SUT training are cited as one of the top reasons for cGMP compliance inspection failures by drug manufacturers. Therefore, a concerted effort is needed in the biopharmaceutical industry to boost training competency across SUT operators. Recognizing the training gap, Pall Corporation and Lonza, embarked on a partnership to develop a standardized and comprehensive SUT training platform that combined the expertise of supplier and end-user. The program leverages a blend of digital media, virtual reality (VR) and in-person training tools to accommodate different learning styles. This variety of training tools helped to overcome the physical constraints of some types of single-use equipment to support the rapid and robust transfer of knowledge and skills required for consistent, strong performance…
Implementing Quality by Design for AAV Products
In this podcast, we talked with Parth Trivedi, Business Development Manager, Pall Corporation, about the importance of implementing a Quality by Design strategy for AAV product manufacturing and specific key steps for successful assessment…
Enhance Your Cell Culture Performance with Chemically Defined Peptides
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…
Addressing the need for flexible large-scale virus production with an intensified, integrated platform
The biopharmaceutical industry has experienced unprecedented growth in recent years due to approvals for novel genomic medicines and increased need for agile, scalable vaccine production capacity to respond to emerging infectious diseases. This growth has placed tremendous pressure on virus manufacturers to increase and intensify virus production and provide industry stakeholders with superior solutions. Process intensification and integrated end-to-end continuous manufacturing are key to ensuring robust virus production with improved process economics…
The cQrex® GQ effect: Boosting viral vector yield and quality in HEK-based AAV-production
Adeno-associated virus (AAV) vectors are a platform technology for gene therapies. Prominent examples authorized for marketing in Europe and the U.S. include Luxturna® and Zolgensma® which are based on AAV2 and AAV9 respectively. For AAV alone, over 260 clinical trials are ongoing. As biopharmaceutical development progresses from clinical to commercial phases, there is an increasing need to improve the productivity of viral vector production processes…
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…
Achieving Peak Flexibility – A single-use filtration skid with multiple application capability
Current expectations for biomanufacturing require downstream systems be responsive and flexible to meet ever changing demands and requirements. A common goal is to create processes that can adapt and evolve over time to meet new needs. To address this need, Agilitech has created a multipurpose filtration system that enables a new level of flexibility. Their compact, single-use multipurpose filtration can be adapted to virtually any commercially available external filtration system and the skid design allows customers to use one skid for multiple applications – sterile filtration, depth filtration, and virus filtration. To provide for future-proof systems, Agilitech encourages customers to partner and co-design solutions that are truly fit for purpose with designs that adapt to evolving needs…
Headlines:
“Pfizer to offer low-cost medicines, vaccines to poor nations,” Associated Press
Pfizer said Wednesday that it will provide nearly two dozen products, including its top-selling COVID-19 vaccine and treatment, at not-for-profit prices in some of the world’s poorest countries. The drugmaker announced the program at the World Economic Forum’s annual gathering in Davos, Switzerland, and said it was aimed at improving health equity in 45 lower-income countries. Most of the countries are in Africa, but the list also includes Haiti, Syria, Cambodia and North Korea…
“U.S. health officials releasing some Jynneos vaccine doses for monkeypox -CDC,” Reuters
U.S. health officials are in the process of releasing some Jynneos vaccine doses for use in monkeypox cases, the Centers for Disease Control and Prevention (CDC) said on Monday. CDC officials said there are more than 1,000 doses of the vaccine, approved in the United States in 2019, in the national stockpile and they expect that level to ramp up very quickly in the coming weeks…
“Pfizer says third Covid vaccine shot for kids under 5 is 80% effective against omicron,” CNBC
Pfizer and BioNTech’s three-dose Covid vaccine for children 6 months to 5 years old was 80% effective at preventing illness during the omicron wave, according to preliminary clinical trial results released Monday. A third dose of the vaccine elicited a strong immune response and was well tolerated by the kids with a majority of the side effects mild to moderate, according to the companies…
“Regeneron’s Evinacumab Fights Ultra-Rare Form of High Cholesterol in Kids,” BioSpace
Regeneron Pharmaceuticals shared positive results from its Phase III trial of a candidate drug for children with homozygous familial hypercholesterolemia (HoFH), a rare, life-threatening condition characterized by elevated circulating levels of low-density lipoprotein cholesterol (LDL-C) and accelerated, premature atherosclerotic cardiovascular disease (ACVD)…
“Precision BioSciences makes case for 2 gene editing programs over CRISPR with preclinical data,” FierceBiotech
Precision BioSciences is leaving the annual meeting of cell and gene therapy stakeholders with confidence, touting two preclinical studies suggesting that its Arcus platform can go toe-to-toe against CRISPR. Presentation of the data at the American Society of Gene and Cell Therapy annual meeting was, above all, an opportunity to showcase the company’s platform, which was derived from I-CreI, a naturally occurring gene editing enzyme that comes from algae. According to Precision Chief Scientific Officer Derek Jantz, Ph.D., Arcus’ X-factor is its ability to make insertions to the genome as opposed to only eliminating gene function…
“CureVac and myNEO will Leverage mRNA Learnings for Cancer Vaccines,” BioSpace
Germany’s CureVac is partnering with Belgium’s myNEO to identify specific cancer antigens in order to develop novel mRNA immunotherapies for cancer vaccines. myNEO will utilize its biological datasets and integrated machine learning and bioinformatics platform to identify and validate specific targets that they think will stimulate a strong immune response…
“Moderna tunes vaccine platform to next potential viral threat: monkeypox,” FierceBiotech
As cases of monkeypox continue to creep up worldwide, Moderna is turning its vaccine platform towards finding a jab to defend against the disease. The Cambridge, Massachusetts biopharma, responsible for one of the most effective COVID-19 vaccines on the market, announced plans to explore potential vaccines for monkeybox at a “preclinical level,” according to a Monday announcement…