This week’s headlines include: U.S. plans to invest billions in manufacturing COVID-19 vaccine, NIH long-term study on children who had COVID-19 enrolls first participant, Biden administration to buy Pfizer antiviral pills for 10 million people, hoping to transform pandemic, BioMagnetic Solutions to Build cGMP Production Facility at Penn State, Biden picks former FDA Commissioner Dr. Robert Califf to run the agency, and J&J previews $60B-a-year future with plans to go after viruses that have long evaded vaccine makers.

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

Cool Tool – Expedite Media Optimization with Viral Vector HEK Media Panel

Among viral delivery systems, recombinant adeno-associated viruses (AAVs) have become the preferred vector for gene therapy because of their high transduction efficiency, safety profile, and long-term gene expression. The increasing number of gene therapy programs has increased the demand for these viral vectors in a clinical setting despite recent setbacks. However, AAV production in a GMP setting at the required yield and purity needed to meet expanding clinical demand remains a hurdle with current production systems and global capacity…

Cell Culture Media Analysis for Gene Therapy

The genes within our cells contain the necessary information to direct the production of proteins and enzymes to support normal functions in the body. However, when a gene or part of a gene is defective, mutated or missing, this can disrupt normal functions manifesting in a number of health problems and diseases. Gene therapy aims to treat diseases through genetic modification, most frequently genetically engineered viral vectors are used to deliver a genetic payload to the cells. There are non-viral methods in development, however, viral vectors are still the most popular approach with two-thirds of the clinical trials to date delivered via viral vector.¹ It has the potential to transform medicine and create new therapeutic options for patients who are living with difficult, and even incurable, diseases. The gene therapy can be delivered directly in vivo to affected cells through either providing the cell with working copies of the gene or by silencing mutated genes that function improperly and cause disease. Another gene therapy strategy aims to reengineer cells ex vivo to increase their therapeutic efficacy against a target population. This is the principle behind CAR T-cell therapy where the patient’s own immune cells are collected and modified with viral vectors in a laboratory before being reintroduced to the patient where they can exert their effect against the target cancer cells in vivo…

Cell Culture Media Analysis for Cell Therapy Applications

In the field of regenerative medicine, cell therapies are increasingly becoming viable therapeutic alternatives to traditional treatments for a wide range of diseases. Most recently, T-cells have been the focus of much clinical investment with chimeric antigen receptor (CAR) T-cell immunotherapies for blood cancers, but other cell types including mesenchymal stem cells (MSCs) and other immune cells (i.e., NK cells, macrophages) have also been investigated for their therapeutic potential. Regardless of the cell type, understanding the best way to culture the cells in vitro to achieve optimal cell activation and expansion, while maintaining functionality is key to the success of these “living medicines”…

Amplifying Adenoviral Particles in the Corning HYPERStack Cell Culture Vessel

Adenoviruses and other viral systems are routinely used in research and industrial applications. Reports indicated that the use of adenoviruses for the delivery of transgenes is one of the most commonly used tools in both in vitro and in vivo research. Additionally, adenovirus transductions have been recently used at both the preclinical and clinical stages in cell therapy and vaccine production leading to an increase in demand to produce more virus as efficiently as possible…

Maximize your budget and increase throughput – Frequently Asked Questions about Refurbished Equipment

Companies often find themselves in a situation where a new piece of equipment would be very useful to increase throughput, reduce manual labor burdens, or replace an older or troublesome machine in their existing workflow. However, there are times when budget constraints or lack of supply may prevent immediate purchase and implementation. One alternative solution is to purchase refurbished equipment from a reputable supplier…

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)…

Mastering the Fundamentals of Oligo Development

With over 300 candidates in clinical trials, oligonucleotides are one of the most promising therapeutic modalities and for the foreseeable future – and solid phase synthesis remains the gold standard approach for manufacturing. Benefits include the relative ease of developing a synthesis route, the straightforward path to scale-up and improved in-process controls. For all the complexity that exists in oligonucleotide development – from end to end – a mastery of synthesis fundamentals can go a long way toward a successful run…

Future-proof Bioprocesses: Flexible Single-use Technology that Adapts to an Evolving Industry

The one constant in biopharmaceutical manufacturing is change. There is an ever-present need to adapt to new therapeutic modalities, more cost-effective approaches, higher product demands, and now a worldwide pandemic. Thus, the best way to ensure efficient biomanufacturing is to future-proof bioprocesses with flexible systems that enable companies to respond to changing priorities, new opportunities, and increasing demands. Processes frequently change as a result of new enabling technologies. The advent of single-use systems, perfusion culture, as well as better analytical tools and sensors are just a sampling of the technologies that have changed bioprocessing over the past decade; however, implementing these improvements is not straightforward. Bioprocesses are not always built with the kind of flexibility that allows them to quickly adapt to improvements…

Headlines:

“U.S. plans to invest billions in manufacturing COVID-19 vaccine,” Reuters

The United States plans to invest billions of dollars in expanding COVID-19 vaccine manufacturing capacity and make available an additional one billion doses per year, White House COVID-19 coordinator Jeff Zients said on Wednesday…

“NIH long-term study on children who had COVID-19 enrolls first participant,” The Hill

A long-term National Institutes of Health (NIH) study on the impacts of COVID-19 on children and young adults enrolled its first participant, the agency announced on Monday. The NIH’s research intends to follow 1,000 children and young adults ages 3 to 21 who previously tested positive for COVID-19 over three years to examine the virus’s impact on their physical and mental health, including their development and immune responses to the virus…

“Biden administration to buy Pfizer antiviral pills for 10 million people, hoping to transform pandemic,” The Washington Post

The Biden administration is planning to purchase 10 million courses of Pfizer’s covid pill, a $5 billion investment in a treatment that officials think will help change the trajectory of the coronavirus pandemic by reducing severe illness and deaths, according to two people with knowledge of the transaction…

“BioMagnetic Solutions to Build cGMP Production Facility at Penn State,” Contract Pharma

Gamma Biosciences, a global life sciences company focused on advanced therapies, announced its portfolio company BioMagnetic Solutions (BMS) has signed a lease with GLP Development to build a cGMP-grade production facility in Innovation Park at Penn State. The site is expected to be fully operational in mid-2022 with more than 13,000 sq.-ft. of purpose-built office, laboratory, and cGMP manufacturing space. ISO 13485 and ISO 9001:2015 certifications have also been achieved to ensure the highest quality standards…

“Biden picks former FDA Commissioner Dr. Robert Califf to run the agency,” CNBC

President Joe Biden announced Friday he has nominated Dr. Robert Califf to serve as the chief of the Food and Drug Administration. The FDA, currently overseen by acting Commissioner Woodcock, has been without a permanent chief since Biden took office in January. The White House reportedly ruled out Woodcock after she faced opposition from some members of Congress over her handling of opioids while at the agency.

“J&J previews $60B-a-year future with plans to go after viruses that have long evaded vaccine makers,” FierceBiotech

Johnson & Johnson has a lofty goal to become a $60 billion-a-year drugmaker by 2025. To reach that goal, the healthcare giant is going to take a crack at a couple of viruses that have long eluded vaccine makers. The company gave investors a broad look at its pipeline Thursday at its Pharmaceutical Business Review day following the news that the consumer health business would be spun out. Ahead of the marathon pipeline preview, Fierce Biotech talked to the Janssen pharmaceutical unit’s new vaccine R&D chief Penny Heaton, M.D., to get the latest on the programs now under her purview…