This week’s headlines include: US buys 105 million COVID vaccine doses for fall campaign, Omicron sub-variants BA.4, BA.5 make up more than 50% of U.S. COVID cases – CDC, Schrödinger to kick off first human trial of its computer-designed blood cancer drug, FDA advisers recommend updating COVID booster shots for fall, FDA official: Virtual audits, records requests may be sticking around, and ReCode breaks the mold with $120M financing, bringing clutch of Big Pharmas along for ride.
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:
A highly effective transient transfection reagent that can be used to produce high-quality, regulatory compliant therapeutic viral vectors for patient administration. The field of cell and gene therapy is expanding rapidly, which has increased the demand for the viral vectors used for in vivo and ex vivo gene transfer. Adeno-associated viral vectors (AVV) are the preferred vectors thanks to their safety profile, broad tropism, and non-integrating properties. In the quest to achieve the high AAV quantities necessary to treat patients, there is a need for industrialized scalable viral vector production platforms that adhere to regulatory good manufacturing practice (GMP) guidelines…
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…
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…
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…
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…
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…
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…
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…
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…
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…
U.S. health officials said Wednesday they have agreed to purchase another 105 million doses of Pfizer’s COVID-19 vaccine in anticipation of a fall booster campaign. The $3.2 billion deal announced by the Biden administration comes as federal scientists consider how to update the vaccines to better protect Americans from the rapidly evolving virus. Federal officials said the purchase agreement includes the option to purchase a total of 300 million doses, including a mix of doses for both adults and children…
The fast-spreading BA.4 and BA.5 sub-variants of Omicron are estimated to make up a combined 52% of the coronavirus cases in the United States as of June 25, the U.S. Centers for Disease Control and Prevention (CDC) said on Tuesday…
After working with biotechs and Big Pharmas to accelerate their research programs, high-tech molecule modeler Schrödinger is taking its first steps as a clinical company itself. It has secured an FDA green light to study its computer-designed therapy for non-Hodgkin lymphomas in an early-phase trial. The company’s machine-learning-powered platform sorted through 8.2 billion potential compounds over a period of 10 months, identifying 78 that were synthesized and filtered through preclinical experiments to select the most promising candidate…
At least some U.S. adults may get updated COVID-19 shots this fall, as government advisers voted Tuesday that it’s time to tweak booster doses to better match the most recent virus variants. Advisers to the Food and Drug Administration wrestled with how to modify doses now when there’s no way to know how the rapidly mutating virus will evolve by fall — especially since people who get today’s recommended boosters remain strongly protected against COVID-19′s worst outcomes…
The US Food and Drug Administration (FDA) plans to use a hybrid inspection model going forward as it eases out of its pandemic response mode, combining a mix of record requests, remote interactive evaluations (RIEs) with onsite inspections if needed, asserted Alonza Cruse, director of FDA’s pharmaceutical quality operations. Cruse discussed how the agency is transitioning to normal operators at the 22 June Drug Information Association (DIA) annual meeting in Chicago. Michele Piepoli, a senior quality consultant with MHP Consulting also highlighted some of the challenges with virtual inspections and records requests and shared some best practices on managing these audits…
ReCode Therapeutics has stuck to a formula of $80 million funding rounds, but, thanks to investments from the venture arms of Bayer and Amgen, the genetic medicine and mRNA biotech is breaking the mold with a $120 million extended series B. The initial $80 million series B financing round was announced last October and co-led by Pfizer Ventures—an active investor in biotechs and emerging science the Big Pharma deems promising—with recent contributions fueling Dren Bio and ImCheck Therapeutics, among others. The other leader was EcoR1 Capital, a San Francisco biotech investment firm that boasts 65 portfolio companies. Other initial series B investors included Sanofi Ventures, Orbimed, Vida Ventures and more…
