This week’s headlines include:Liquidyne Process Technologies, Inc. Unveils New Brand Identity Reflecting Company’s Commitment to Making Life Better, Industry calls for flexibility on RWD data sources, validation, Moderna starts trial for Omicron-specific booster shot, Moderna, Excision each enter HIV battle with mRNA and CRISPR tech, Biden administration officially withdraws vaccine rule, Sinovac regimen gets strong boost from Pfizer, AstraZeneca or J&J COVID shots – study, and Do not assume COVID pandemic reaching ‘end game’, warns WHO.

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

Top Cell Culture Dish Podcasts 2021

Don’t miss our top Podcasts of 2021! I have compiled a list of our most popular podcasts for 2021 in alphabetical order…

Revolutionizing the Standard of 3D Bioprinting with the Corning® Matribot® Bioprinter

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…

Biopharma Solutions – What we can Learn from the Pandemic

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…

Utilizing N-1 Perfusion to Increase Productivity and Intensify Processes

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…

Rapid Qualification Strategy of a Real-Time PCR Mycoplasma Detection Kit for an MSC-based Cell Therapy

Advanced therapies encompass a diversity of cell- and gene-based therapeutic platforms that are intended for human use. The exceptional promise of many cell and gene therapies to change the standard of patient care across a variety of disease indications has driven significant financial investment in the field and many products are now progressing through the clinical pipeline towards market approval. While approved products have already had a profound impact on patients, new scientific progress, clinical advances targeting large indications, and an evolving and supportive regulatory environment provide greater opportunity for these therapies in the future. Despite the forward progress, a stumbling point for cell and gene therapies has been that the condensed clinical development timelines, complex manufacturing processes, short shelf-life of the products, and supply chain challenges make it difficult for developers to ensure timely testing of quality and safety attributes…

Top Downstream Process Articles of 2021

Don’t miss our top articles on downstream processing for 2021! I have compiled a list of our most popular articles from 2021 in alphabetical order…

DAC ERGO takes column changeover from unwieldy to manageable

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…

Cool Tool – OCELOT™ System Control Provides Flexible Automation for Process Precision

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…

Addressing the increasing demand for single-use technologies and supply chain shortages with future proof systems

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…

Driving Efficiency and Ingenuity with an OPC Platform

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)…

Headlines:

“Liquidyne Process Technologies, Inc. Unveils New Brand Identity Reflecting Company’s Commitment to Making Life Better,” Yahoo Finance

Liquidyne Process Technologies, Inc, a leader in supplying pharmaceutical and biotech manufacturing with single-use technology and sanitary process equipment, unveiled its new brand identity reflecting the company’s commitment to transforming the customer experience within B2B commerce. Liquidyne’s fresh look and feel represent a strengthening of its 29-year commitment to Making Life Better…

“Industry calls for flexibility on RWD data sources, validation,” Regulatory Focus

Industry leaders want to see more flexibility and clarity from the US Food and Drug Administration (FDA) as it seeks to finalize guidance on the use real-world data (RWD) from electronic health records (EHRs) and medical claims to support regulatory decision-making…

“Moderna starts trial for Omicron-specific booster shot,” Reuters

Moderna Inc (MRNA.O) said on Wednesday it had started a mid-stage study, testing a booster dose of its COVID-19 vaccine specifically designed to target the Omicron coronavirus variant, a day after rival Pfizer Inc (PFE.N) launched a similar trial…

“Moderna, Excision each enter HIV battle with mRNA and CRISPR tech,” FierceBiotech

Moderna and Excision BioTherapeutics are stepping into a battle with HIV, a 41-year epidemic that has confuddled drug developers and vaccine makers the world over. The COVID-19 vaccine maker has started applying its mRNA technology to deliver a jab for HIV on the same day Excision says it’s begun investigating a CRISPR-based therapy for the immune-system attacking virus…