This week’s headlines include: FDA approves storing Pfizer vaccine at standard freezer temperature, Contagious Brazil COVID-19 variant evades immunity, scientists warn, FogPharma comes through the clearing with a meaty $107M raise for ‘undruggable’ targets, Biden now says US will have enough vaccine for every adult by the end of May, UK finds vaccines 80% effective at preventing hospitalisations in over-80s, EMA, Health Canada publish Moderna data package, Inovio expects COVID-19 vaccine U.S. trial data by early second quarter, and Merck Snaps Up Autoimmune-Focused Pandion in Massive $1.85 Billion Deal.

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:

Covid-19 Resources:

As the SARS-CoV-2 pandemic has spread around the world, scientists, doctors, clinicians and biopharmaceutical companies are working hard to find effective therapies for COVID-19 disease. Approved and investigational medications with a spectrum of activities are being examined as to whether they can be repurposed for COVID-19 and vaccines are being researched and tested for rapid delivery. Due to the magnitude of the effort by all involved, it is difficult to keep track of the numerous therapeutic, discovery and manufacturing related resources available.

We have created this page to house articles that Cell Culture Dish publishes related to Covid-19 and links to resources from suppliers who have gathered information, technologies and techniques that could be helpful for those engaged in Covid-19 related research and manufacturing. Covid-19 Resources

Webinar:

Don’t miss Brandy Sargent, Editor in Chief, Cell Culture Dish is moderating a webinar for a Two-Part Gene Therapy Webinar Series

Webinar 1: Gene Therapy Downstream Manufacturing, Scale-up and Best Practices

• Tuesday, March 9 – 8:00am PST | 11:00am EST | 4:00pm GMT
• Thursday, March 11 – 9:00am CET | 1:30pm IST | 4:00pm CST | 5:00pm JST

Gene therapies provide innovative options for treating patients, particularly where other traditional therapeutics have been ineffective. The industry continues to grow and mature from research to approved therapeutics. The latest industry trends and innovations have been detailed in the ebook, “Insights on Successful Gene Therapy Manufacturing and Commercialization” where thought leaders share their perspectives.

In this panel webinar series, hear directly from the authors on various topics related to gene therapy manufacturing and commercialization, the current state of the industry and how we can continue to advance these life-changing medicines.

Register Here

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

Securing Sustainable Reimbursement for Innovative Gene Therapies

The insights into reimbursement of gene therapies presented in this article explore challenges and potential solutions based on the U.S. healthcare landscape. While not directly applicable to other nations, risks and solutions identified here may be a starting point for exploration of short and long-term sustainability discussions for other countries...

Evolution of Viral Vector Analytics for Gene Therapy Manufacturing

With over 350 cell and gene therapies in clinical trials in the US and more than 700 globally, the explosive growth in the field is only expected to increase in the years to come. This rapid progress from clinical development towards product licensure has resulted in a viral vector supply bottleneck. The challenge in viral vector-manufacturing capacity is estimated to be 1–2 orders of magnitude lower than what is needed to support current and future commercial supply requirements. Concomitantly, regulatory scrutiny and product characterization requirements are increasing, as more gene therapy products reach commercialization…

Cell Culture Dish – Top 10 Cool Tools of 2020

Don’t miss our top Cool Tools of 2020! I have compiled a list of our 10 most popular Cool Tools for 2020 in alphabetical order…

Deciphering Continued Process Verification and Automating the Process for Straightforward Implementation

Continued process verification (CPV) is used by biopharmaceutical companies to ensure that the manufacturing process for a therapeutic remains in a continual state of control during the lifecycle of the product. This is to make certain that the final drug product’s strength, quality and purity is maintained for the product’s duration on the market. Both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have directed manufacturers to develop a CPV program to collect and analyze product and process data to evaluate the state of their manufacturing controls and to identify any product or process problems. It also provides the opportunity to evaluate and implement process improvements…

Next Generation Proteomics is the Missing Piece in Completing the Precision Medicine Puzzle

Twenty years ago, the International Human Genome Sequencing Consortium constructed a map of the human genome and with it came the opportunity to look at medicine in new way. The idea of precision medicine, an approach to medicine where an individual’s genes, environment, and lifestyle is considered in disease treatment selection, was enabled for the first time and with it the hope for targeted therapeutics. In spite of this significant advancement, we still primarily employ a one-size-fits-all therapeutic approach to medicine today. Unfortunately this approach does not yield the kind of results that precision medicine aspires to. Why have we not been able to fully employ precision medicine? Many believe that this is due in large part to the inability to harness proteomics as the missing piece of the precision medicine puzzle…

The BioContinuum™ Buffer Delivery Platform Provides Solutions to Costly Buffer Management Pain Points

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

Securing Sustainable Reimbursement for Innovative Gene Therapies

The insights into reimbursement of gene therapies presented in this article explore challenges and potential solutions based on the U.S. healthcare landscape. While not directly applicable to other nations, risks and solutions identified here may be a starting point for exploration of short and long-term sustainability discussions for other countries...

Evolution of Viral Vector Analytics for Gene Therapy Manufacturing

With over 350 cell and gene therapies in clinical trials in the US and more than 700 globally, the explosive growth in the field is only expected to increase in the years to come. This rapid progress from clinical development towards product licensure has resulted in a viral vector supply bottleneck. The challenge in viral vector-manufacturing capacity is estimated to be 1–2 orders of magnitude lower than what is needed to support current and future commercial supply requirements. Concomitantly, regulatory scrutiny and product characterization requirements are increasing, as more gene therapy products reach commercialization…

Cell Culture Dish – Top 10 Cool Tools of 2020

Don’t miss our top Cool Tools of 2020! I have compiled a list of our 10 most popular Cool Tools for 2020 in alphabetical order…

Deciphering Continued Process Verification and Automating the Process for Straightforward Implementation

Continued process verification (CPV) is used by biopharmaceutical companies to ensure that the manufacturing process for a therapeutic remains in a continual state of control during the lifecycle of the product. This is to make certain that the final drug product’s strength, quality and purity is maintained for the product’s duration on the market. Both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have directed manufacturers to develop a CPV program to collect and analyze product and process data to evaluate the state of their manufacturing controls and to identify any product or process problems. It also provides the opportunity to evaluate and implement process improvements…

Next Generation Proteomics is the Missing Piece in Completing the Precision Medicine Puzzle

Twenty years ago, the International Human Genome Sequencing Consortium constructed a map of the human genome and with it came the opportunity to look at medicine in new way. The idea of precision medicine, an approach to medicine where an individual’s genes, environment, and lifestyle is considered in disease treatment selection, was enabled for the first time and with it the hope for targeted therapeutics. In spite of this significant advancement, we still primarily employ a one-size-fits-all therapeutic approach to medicine today. Unfortunately this approach does not yield the kind of results that precision medicine aspires to. Why have we not been able to fully employ precision medicine? Many believe that this is due in large part to the inability to harness proteomics as the missing piece of the precision medicine puzzle…

The BioContinuum™ Buffer Delivery Platform Provides Solutions to Costly Buffer Management Pain Points

Buffer management is a significant logistical challenge in biomanufacturing and is the cause of many bottlenecks. While it is an essential function in downstream processing, it does not provide added value commensurate with the level of footprint, labor and equipment investment required…

Top Downstream Process Articles of 2020

Don’t miss our top articles on downstream processing for 2020! I have compiled a list of our most popular articles from 2020 in alphabetical order…

Downstream Manufacturing of Gene Therapy Vectors

The downstream manufacturing process takes the output from upstream operations and transforms it through multiple steps into a viable drug product ready for administration to patients. The major challenge in downstream processing is to maximize yield while meeting both product and impurity specifications. Viral vectors destined for clinical use must comply with regulatory standards for product safety and potency and this means contaminants must be removed and impurities controlled…

Addressing Downstream Throughput Bottlenecks with Rapid Cycling Protein A Based Fiber Chromatography

Faster process times and increased flexibility in manufacturing continue to be key drivers in both upstream and downstream processing. New technologies are needed to address bottlenecks and to infuse more flexibility in process development and manufacturing. For downstream, chromatography purification can be a resource intensive step and a source of bottlenecks due to decreased throughput. While improvements in Protein A chromatography resins, such as high capacity resins, provide much better capacity, low flow rates are still a potential source of slow downs. One alternative solution for addressing areas where increased throughput and flexibility is required is the use of Fiber based chromatography…

Headlines:

“FDA approves storing Pfizer vaccine at standard freezer temperature,” The Hill

The Food and Drug Administration (FDA) on Thursday approved storing Pfizer’s COVID-19 vaccine at standard freezer temperatures, helping ease storage requirements that could make delivery of the vaccine easier. The Pfizer vaccine had previously been required to be stored in ultra-cold freezers at minus 112 degrees Fahrenheit to minus 76 degrees Fahrenheit. That posed a challenge for distribution of the vaccine in places like rural areas or lower income countries that do not have widespread ultra-cold storage capability…

“Contagious Brazil COVID-19 variant evades immunity, scientists warn,” Reuters

A highly transmissible COVID-19 variant that emerged in Brazil and has now been found in at least 20 countries can re-infect people who previously recovered from the disease, scientists said on Tuesday. In a study of the mutant virus’s emergence and its spread in the Amazon jungle city of Manaus, the scientists said the variant – known as P.1 – has a “unique constellation of mutations” and had very rapidly become the dominant variant circulating there…

“FogPharma comes through the clearing with a meaty $107M raise for ‘undruggable’ targets,” FierceBiotech

It’s been a relatively quiet few years for FogPharma, at least publicly, but now the Cambridge, Massachusetts-based biotech is revealing a major funding round. The series C has been pumped up to $107 million from a who’s who of venture capitalists. The round was led by venBio Partners with help from new investors Cormorant Asset Management, Farallon Capital Management, Invus, funds and accounts advised by T. Rowe Price Associates Inc., HBM Healthcare Investments, Casdin Capital and PagsGroup…

“Biden now says US will have enough vaccine for every adult by the end of May,” CNN