This week’s headlines include: Victories against AIDS have lessons for COVID-19, Pfizer, BioNTech vaccine neutralises Omicron with three shots, New data shows GSK-Vir drug works against all Omicron mutations, Metis Therapeutics emerges with $86M for 2022 clinic entry, push into gene therapy, Gene editing produces all-male or all-female litters of mice, UK orders extra 114 million COVID-19 vaccines to combat Omicron, and Novartis Inks Potential $1.5 Billion Parkinson’s Deal with UCB.

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:

Online Conference:

TECHNOLOGY’S EVOLUTION & IMPACT ON MANUFACTURING

Learn how to navigate your competition, reduce investment, shorten construction time, improve processes, and compatibility upstream and downstream at Technology’s Evolution and Impact on Manufacturing conference on Dec 14.

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

Closed and Aseptic Processes for Cell Therapy Manufacturing

In this article, we identify key strategies to help researchers successfully transition their cell therapies from the lab to commercial production. We detail the advantages of implementing closed systems as well as some of the key hurdles when transitioning from traditional bioprocesses…

The scale-X™ carbo bioreactor: flexible GMP viral production at bench scale in adherent or suspension processes

Producing viral products for vaccines or cell and gene therapy starts with cell culture, where bioprocessing equipment must be selected to ensure conditions established at bench-scale can be successfully translated to the clinics and onwards. A successful development and manufacturing platform must result in low cost of goods for the final product, high design robustness (low risk of failure) and ease of use and scale-up…

Increasing speed and efficiency of biotherapeutic drug development with stable pools

In this podcast, we talked with Dr. Alison Porter, Head of Expression System Sciences, Lonza, about the use of stable pool expression to reduce drug development timelines. Highlights included implementation of stable pools in current workflows, expected titers, and cutting-edge applications of the technology…

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. 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…

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:

“Victories against AIDS have lessons for COVID-19,” Nature

Anthony Fauci on four decades of progress against HIV, and what’s needed for the future. Amid the COVID-19 pandemic, a milestone of another global scourge has largely escaped the spotlight. It has been 40 years since the earliest reports of what ultimately became known as AIDS, in 1981. I initially dismissed the first report as a curiosity and probably a fluke, but another a month later, from the US Centers for Disease Control and Prevention, changed my mind and the direction of my career. Against the advice of my mentors, I shifted my research focus to understanding why young, healthy men were being beset by unusual conditions. I remember anxiously awaiting results essential in the fight against a disease that brought on so many seemingly unrelated symptoms: pneumonia, blindness, skin lesions, dementia…

“Pfizer, BioNTech vaccine neutralises Omicron with three shots,” Reuters

BioNTech and Pfizer said on Wednesday a three-shot course of their COVID-19 vaccine was able to neutralise the new Omicron variant in a laboratory test, an early signal that booster shots could be key to protection against infection from the newly identified variant. The German and U.S. companies said two doses of their vaccine resulted in significantly lower neutralising antibodies but could still be protective against severe disease…

“New data shows GSK-Vir drug works against all Omicron mutations,” Reuters

British drugmaker GSK said on Tuesday its antibody-based COVID-19 therapy with U.S. partner Vir Biotechnology is effective against all mutations of the new Omicron coronavirus variant, citing new data from early-stage studies. The data, yet to be published in a peer-reviewed medical journal, shows that the companies’ treatment, sotrovimab, is effective against all 37 identified mutations to date in the spike protein, GSK said in a statement…

“Metis Therapeutics emerges with $86M for 2022 clinic entry, push into gene therapy,” Fierce Biotech

The idea began when Chris Lai, Ph.D., met with MIT researchers at a Starbucks in Belmont, Massachusetts, in 2017. Now, Lai’s venture has $86 million (PDF) in series A financing to bankroll a 2022 clinical trial and an expansion into gene therapy. The CEO kept most details about Metis Therapeutics under wraps but said the company will use the fresh proceeds to fuel the first human test of its lead candidate early next year. The funds will also back licensing deals to pick up early-stage discovery assets and candidates almost ready for the clinic, Lai said in an interview with Fierce Biotech…

“Gene editing produces all-male or all-female litters of mice,” Science

In some farmers’ ideal world, cows would birth only females, sows would bear no boars, and chicks would all grow up to be hens. Such sex ratios would stop them from killing millions of male animals, which don’t produce eggs or milk. Now, scientists are a step closer to this reality. Researchers have harnessed the gene editor CRISPR to produce litters of mice all of one sex. That’s a potential boon to agriculture and may offer a more immediate advantage in scientific research. “The paper shows a state-of-the-art solution to producing single-sex species” with “impressive results,” says Ehud Qimron, a CRISPR expert at Tel Aviv University who was not involved with the work. The impact for lab animals may be huge. “In the past 5 years around 25,000 papers were published using mice in sex-specific research studies,” says study co-author James Turner, a molecular geneticist at the Francis Crick Institute. “If we could prevent the generation of the unstudied sex, the number [saved] would be in the hundreds of thousands.”

“UK orders extra 114 million COVID-19 vaccines to combat Omicron,” PharmaTimes Online

Scientists and health experts have cautioned that the new variant could have the ability to bypass the effectiveness of vaccines that are currently available. The UK government has signed two new contracts for an additional 114 million doses of the Pfizer and Moderna vaccines in an effort to tackle the emerging threat of the new Omicron variant…

“Novartis Inks Potential $1.5 Billion Parkinson’s Deal with UCB,” BioSpace

Novartis held an investor event to discuss their research programs, but clearly, the highlight was its partnership with Belgian pharma company UCB worth up to $1.5 billion. The two companies will co-develop and commercialize two drugs targeting Parkinson’s disease, UCB0599 and UCB7853…