This week’s headlines include: AI Predicts Next Coronavirus Animal Hosts, CDER unveils 30 new planned guidance documents in 2022 agenda, FDA Approves Enjaymo for Treatment of Cold Agglutinin Disease, New CRISPR tool maps out routes to better immune cell therapies for cancer, autoimmune diseases, Amgen to buy back $6 bln in shares this qtr, provides long-term profit forecast, As case counts fall, WHO chief warns “COVID isn’t finished, and US plans to roll out initial 10 million Covid-19 vaccine doses for children under 5 after FDA authorization, CDC document says.
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3D bioprinting is a powerful tool with the potential to fast-forward translational research for tissue engineering and regenerative medicine. The concept is simple – depositing cells layer by layer following a prescribed 3D pattern to create tissue-like structures that emulate in vivo environments – but complicated to execute. The long-term goal is to use 3D bioprinting to fabricate viable human tissues and organs for transplantation to alleviate the need for living or deceased human donation. Using a patient’s own cells to bioprint an organ could circumvent immune rejection and translate to better clinical outcomes. While the technology is not there yet, 3D bioprinting could be used to create complex biomimetic tissue models to test novel drug therapies, develop patient-specific treatment regimens, and study complex physiological processes. Moreover, 3D bioprinting can be used to generate large-scale constructs using cellular aggregates like spheroids or organoids as building blocks. The specific 3D arrangement of cells within these models reproduces structural features seen in vivo. The spatial distribution of cells, the cell-cell and cell-matrix interactions provide greater predictive power than 2D monolayer cultures and animal models. Although current 3D models, like tissue-specific organoids, have provided insight into developmental and disease mechanisms, the inability to control the organization of the cells within the structures presents a number of limitations that may be solved by 3D bioprinting. Over the past decade, remarkable advancements in bioprinting technologies (i.e., 3D bioprinters and bioink composition) have enabled the biofabrication of realistic 3D biological structures with improved architectural quality and functionality. However, there are still technological challenges to overcome as the field continues to mature and diversify to address more complex questions…
The speed with which the COVID-19 vaccines were brought to fruition is possibly one of the greatest achievements in biopharmaceutical history. United by a common goal, unprecedented global collaboration driven by innovative technologies has proved what the industry is capable of and has catalyzed progress across the biopharmaceutical industry. In a recent e-book by The Medicine Maker and Pall – Seeking Solutions in Biopharma– experts come together to reflect on the pandemic response and how it has spurred changes in the biopharmaceutical manufacturing paradigm with the goal of helping drug developers move more easily and quickly through different stages from discovery to manufacturing…
Perfusion technology is a tool to increase productivity that can be applied at different stages during upstream cell culture for biotherapeutics products. Perfusion allows removal of waste by-products and replenishment of fresh nutrients so that the cells are able to grow and reach higher cell densities and higher productivity. N-1 perfusion, the application of the perfusion technology in the step immediately before the production bioreactor, is a good option for processes that exhibit low productivity. Join Claudia Berdugo, Ph.D., Director of Process Development at Catalent Biologics, where she discusses N-1 perfusion and how Catalent Biologics works toward process improvements for each client to enable them to move their pharmaceutical products forward with confidence…
Chromatography columns are an integral part of many biologic purification processes. As such there has been an increase in the use of large-scale columns, including popular stainless-steel Dynamic Axial Compression (DAC) columns. These columns are flexible as they allow packing of any required bed height to enable a variety of different media types and sizes. In addition, their design allows for a quick, easy and homogenous packed bed as well as an even distribution for plug flow of liquid to achieve better peak resolution…
The biopharma industry has continued to embrace automation as a key part of creating more efficient, cost-effective manufacturing. There are many options for how to automate systems, but a universal requirement is the need for a responsive, built for purpose automation software. In most cases automation software provides a single interface for all applications, while this may seem convenient, it often can’t be configured to meet an end users’ exact process or mode of operation…
In this podcast, we talked with Phil Sanders, Biotech Chief Innovation Officer, Agilitech, about the increase in demand for single-use equipment and consumables and how this has led to supply chain shortages. We also talk about how to address these issues by incorporating strategies like being brand agnostic and designing systems that are future proof…
The regulatory approval of several oligonucleotides over the past five years – combined with the recent headlines around rapid COVID-19 vaccine development – has created significant interest in the oligonucleotide (DNA/RNA) segment of the scientific industry. This includes everything from antisense oligonucleotides (ASOs) to lengthy gene transcript mRNA, as well as shRNA (small hairpin RNA), siRNA (small interfering RNA), CRISPR/Cas9 and anti-miR (anti-micro RNA)…
An international research team has harnessed the power of artificial intelligence (AI) to aid in the search for the next coronavirus host. The study was led by researchers at the Univ. of Oklahoma and Georgetown Univ., and included collaborators from many other universities and research institutes. The authors are part of the Viral Emergence Research Initiative (VERENA) consortium, which curates a massive ecosystem of open data in viral ecology, and creates tools to help predict which viruses could infect humans and which animals could host those viruses…
About one-third of the guidance documents in the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER)’s 2022 guidance agenda are new, with some recognizable documents from previous years making a reappearance. CDER’s guidance agenda, which is widely understood to be a wish list for the center, contains hints about the center’s focus for the year. However, CDER makes it clear that the agenda is not a promise to publish all the listed guidance documents in a given year. In total, 98 guidances are planned for 2022, with 29 new documents, 1 revised document and 66 documents that are carryovers from last year appearing on the list. In contrast, 2020’s list contained 105 guidances, which included 42 new guidances and many existing guidance documents from the previous year…
The FDA has approved sutimlimab-jome (Enjaymo, Sanofi) to decrease the need for red blood cell transfusion because of hemolysis in adults with cold agglutinin disease (CAD). Enjaymo is the first and only approved treatment for individuals with CAD and works by inhibiting the destruction of red blood cells…
The CRISPR gene editing system has offered scientists a powerful tool for studying the effects of altering specific genes. Now, researchers at the Gladstone-UCSF Institute of Genomic Immunology have devised a CRISPR platform that allowed them to discover new roles of genes in human T cells, which they say could aid the design of better cellular immunotherapies…
Amgen Inc (AMGN.O) said on Tuesday it would buy back up to $6 billion of its shares in the first quarter and forecast profit to more than double by 2030 on strong sales of its oncology drugs, biosimilars and other important products…
The head of the World Health Organization insisted Wednesday that “COVID isn’t finished with us,” appealing for more support to fight the pandemic after his agency reported that new infections fell but virus deaths rose worldwide over the past week. Tedros Adhanom Ghebreyesus, launching a new $23 billion campaign to fund WHO’s efforts to lead a fair rollout of COVID-19 tests, treatments and vaccines around the world, cautioned that “diseases know no borders” and the highly-transmissible omicron variant has shown that “any feeling of safety can change in a moment.”…
If the Pfizer/BioNTech coronavirus vaccine receives emergency use authorization from the US Food and Drug Administration for children 6 months to 5 years old, the tentative plan is to roll out about 10 million vaccine doses initially, according to a US Centers for Disease Control and Prevention document posted online. The document, an updated pediatric Covid-19 vaccination planning guide, notes that “planning is for a sequenced rollout involving an initial total of approximately 10 million doses” and that providers and facilities that have ordered doses “must be able to receive vaccine shipment on Monday February 21.”…
