This week’s headlines include: Moderna, Thermo Fisher partner to manufacture COVID vaccine, other drugs, NIH orders sweeping review of potentially risky experiments on viruses and other pathogens, Pfizer’s RSV Vaccine Reaches “Pivotal Next Step” with Breakthrough Therapy Designation, Novartis backs Epsilogen’s bid to turn ‘Cinderella antibody’ into new class of cancer drug, Hundreds of COVID trials could provide a deluge of new drugs, Complex CRISPR Patent Decision Benefits Broad Institute, Editas, Mirus Bio Expandes TransIT-VirusGEN® SELECT Portfolio, PFDD: FDA finalizes guidance on identifying what’s important to patients, IDT Biologika and Exothera Collaborate on Scaling Up Viral Vaccines, and FDA approves cancer therapy by J&J, partner Legend Biotech.

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:

The Cell Culture Dish’s Top Articles of 2021

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

Cell Culture Dish’s Top Posters and Presentations of 2021

Don’t miss our top posters and presentations of 2021! I have compiled a list of our most popular for 2021 in alphabetical order.

New TransfectionSelect™ Product Selection Tool Takes the Guesswork Out of Improving Transfection Efficiency

Cell transfection is a powerful investigative tool used by many scientists to study gene expression and function across a wide range of applications from cell biology, cancer research, bioproduction of proteins and viruses to developing novel gene therapies to treat diseases. Transfection involves introducing foreign nucleic acids (DNA and RNA) or even proteins into eukaryotic cells. Whether you are new to transfection or it is part of your everyday lab routine, ensuring you have the highest transfection efficiency is critical to experimental success. Defined as the percentage of cells transfected over the total cells, optimizing transfection efficiency can be a tricky endeavor as it is prone to many variable factors, such as cell type, health status, size and type of genetic payload, delivery method–it can be difficult to know where to start to improve your transfection…

Top Cell Culture Dish Cool Tools for 2021

Don’t miss our top Cool Tools of 2021! I have compiled a list of our 10 most popular Cool Tools for 2021 in alphabetical order.

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…

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:

“Moderna, Thermo Fisher partner to manufacture COVID vaccine, other drugs,” Reuters

Moderna Inc (MRNA.O) has entered into a long-term agreement with Thermo Fisher Scientific (TMO.N) for the manufacturing of its COVID-19 vaccine and other experimental medicines based on mRNA technology, the companies said on Wednesday. Thermo Fisher had already partnered with Moderna last year to help scale up production of its COVID vaccine, branded as Spikevax…

“NIH orders sweeping review of potentially risky experiments on viruses and other pathogens,” The Washington Post

The National Institutes of Health this week ordered a sweeping review of government policies for experiments involving potentially dangerous viruses and other pathogens, a move the agency said will balance the benefits and risks of such research but is unrelated to the debate over the coronavirus pandemic’s origin…

“Pfizer’s RSV Vaccine Reaches “Pivotal Next Step” with Breakthrough Therapy Designation,” BioSpace

Pfizer notched another win with its vaccine development, this time for the respiratory syncytial virus (RSV) instead of COVID-19. The company announced its RSV vaccine candidate PF-06482077 or RSVpreF, received Breakthrough Therapy designation from the U.S. Food and Drug Administration. The designation was granted to prevent the virus-associated lower respiratory tract illness in infants from birth up to six months of age through the active immunization of pregnant women. It comes days after GlaxoSmithKline was forced to halt enrolment and vaccination in three paused clinical trials assessing a vaccine candidate in pregnant women…

“Novartis backs Epsilogen’s bid to turn ‘Cinderella antibody’ into new class of cancer drug,” FierceBiotech

Novartis has thrown its weight behind a “Cinderella antibody,” leading a 30.8 million pound sterling ($40.9 million) series B round that positions Epsilogen to try to create “a brand new category of pharmaceutical within within cancer.” London-based Epsilogen’s primary focus is an immunoglobulin E (IgE) antibody that targets the folate receptor alpha antigen. While researchers discovered IgE antibodies in 1966, and biologics pioneers considered them at the birth of the biotech industry, Epsilogen claims its candidate is the world’s first IgE antibody to enter the clinic…

“Hundreds of COVID trials could provide a deluge of new drugs,” Nature

It takes Lawrence Tabak about 15 minutes to rattle off all the potential COVID-19 treatments being tested in the clinical trial programme he oversees: a lengthy, tongue-twisting list that includes drugs to disarm the virus, to soothe inflammation and to stop blood clots. Over the past two years, the ACTIV programme, run by the US National Institutes of Health (NIH), has included more than 30 studies — 13 of them ongoing — of therapeutic agents chosen from a list of 800 candidates. Several of the studies are due to report results in the first half of the year…

“Complex CRISPR Patent Decision Benefits Broad Institute, Editas,” BioSpace

CRISPR-Cas9 gene-editing technology was officially discovered in 2012 when Jennifer Doudna, then with the University of California, Berkeley, and Emmanuelle Charpentier, then at the University of Vienna, published their landmark paper in Science. However, the technology has been tangled in patent battles ever since. Feng Zhang, a researcher at the Broad Institute of Massachusetts Institute of Technology and Harvard University, also filed a broad U.S. patent claim on the technology…

“Mirus Bio Expandes TransIT-VirusGEN® SELECT Portfolio,” BioSpectrum Asia

Mirus Bio, a leading provider of delivery solutions within Gamma Biosciences, today launched TransIT-VirusGEN® SELECT Transfection Kits for large-scale viral vector production for cell and gene therapy applications. The kits support pre-clinical and process development activities and consist of the TransIT-VirusGEN Transfection Reagent, complex formation solution and enhancer. The full kits are designed to improve the delivery of packaging and transfer plasmid DNA constructs to suspension and adherent HEK 293 cell types for adeno-associated virus (AAV) or lentivirus (LV) production…