This week’s headlines include: FDA accelerated approvals targeted for revamp in House Energy and Commerce committee chair’s new bill, Pfizer begins stage 2 and 3 trials of COVID-19 antiviral treatment on children, GV-backed DNAnexus snags $200M to build out genomic data analytics platform, Moderna to set up mRNA vaccine manufacturing facility in Kenya, Microbiotica nabs $67M to push 2 microbiome therapies through clinic, Gilead Says Trodelvy Slows Progression of Common Forms of Breast Cancer, NASEM report: FDA should disclose drug and device manufacturing information, and Gene Therapy Trials for Sickle Cell Disease Hold Hope for Durable Effects.

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

A Demonstration of Effective Scalability of Suspension Cells for the Production of rAAV Viral Vectors using the Allegro STR bioreactor System

Reliable and scalable viral vector manufacturing platforms are needed to accommodate the increased demand as more gene therapy treatments are brought to market. These transformative medicines can be used to replace a defective gene with a functional copy, silence a defective gene or even be introduced to directly edit genes in vivo. Not only is the diversity of target indications growing, but the size of the patient population is as well, necessitating better upstream technologies to meet the increased viral vector demand that drive these therapies…

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 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:

“FDA accelerated approvals targeted for revamp in House Energy and Commerce committee chair’s new bill,” FiercePharma

The chairman of the House Committee on Energy and Commerce is taking the FDA’s accelerated approval pathway to task. Frank Pallone Jr., D-New Jersey, on Monday unveiled the Accelerated Approval Integrity Act, which seeks to ensure drugs that enjoy a quick trip through the regulator offer “proven clinical benefit” to patients. “[U]nder the current system, some products have been allowed to stay on the market for far too long without clinical trials that demonstrate a real clinical benefit for patients,” Pallone said in a statement. “Patients deserve to know that the drugs they are taking are safe and effective.”

“Pfizer begins stage 2 and 3 trials of COVID-19 antiviral treatment on children,” The Hill

Pfizer on Wednesday announced it has begun the Phase 2 and 3 stages of its study into the use of its antiviral COVID-19 treatment in young children. The oral COVID-19 treatment called Paxlovid is currently one of two authorized SARS-CoV-2 antiviral treatments in the U.S. It is permitted for use in people as young as 12 who weigh at least 40 kg (88 lbs)…

“GV-backed DNAnexus snags $200M to build out genomic data analytics platform,” FierceBiotech

A single petabyte of data is estimated to be the equivalent of 500 billion pages of standard text. It’s safe to say, then, that with access to more than 65 petabytes of genomic sequencing data, DNAnexus and its data analytics tools could provide a pretty powerful boost to drug and diagnostic developers around the world…

“Moderna to set up mRNA vaccine manufacturing facility in Kenya,” Reuters

Moderna Inc (MRNA.O) said on Monday it would set up a manufacturing facility in Kenya, its first in Africa, to produce messenger RNA (mRNA) vaccines, including COVID-19 shots. Moderna said it expects to invest about $500 million in the Kenyan facility and supply as many as 500 million doses of mRNA vaccines to the continent each year. It also has plans to start filling doses of its COVID vaccine in Africa as early as 2023…

“Microbiotica nabs $67M to push 2 microbiome therapies through clinic,” FierceBiotech

England-based Microbiotica has raised $67 million in a series B round to push two microbiome-based lead assets through phase 1b trials, slated to start this year. The company launched in 2016 to develop bacterial therapies and biomarkers utilizing the human microbiome, which is a source of trillions of microorganisms that exist in the body. The company was founded with GBP 8 million ($10.4 million) in initial funding…

“Gilead Says Trodelvy Slows Progression of Common Forms of Breast Cancer,” BioSpace

One week after the U.S. Food and Drug Administration rejectedits HIV treatment over vial concerns, Gilead Sciences posted some good news in oncology. A late-stage study of its antibody-drug conjugate Trodelvy shows promise in slowing disease progression in some of the most common forms of breast cancer…

“NASEM report: FDA should disclose drug and device manufacturing information,” Regulatory Focus

To ensure resiliency in the medical supply chain, the US Food and Drug Administration (FDA) should publicly disclose the location of all manufacturing facilities that supply ingredients and parts for pharmaceuticals and medical devices approved in the US, according to a consensus study report from the National Academies of Science, Engineering and Medicine (NASEM)…

“Gene Therapy Trials for Sickle Cell Disease Hold Hope for Durable Effects,” BioSpace

Sickle cell disease is nearing a cure. Recent gene therapy research has created what appears to be a durable response in terms of producing normally-shaped red blood cells and completely reducing the pain associated with the disease. The study, Biologic and Clinical Efficacy of LentiGlobin for Sickle Cell Disease, published in the New England of Medicine (NEJM) and funded by bluebird bio, outlines a successful approach that adds a gene to the stem cells that eventually become blood-producing cells…