This week’s headlines include: White House to roll out Johnson & Johnson vaccine doses next week, pending authorization, EU regulator says Celltrion’s COVID-19 antibody drug under real-time review, U.S. poised to have 3M vaccine doses available per day by April, FDA says Covid vaccines that target new variants won’t need large clinical trials to win approval, ONK Therapeutics enters collaboration with blood cancer charity Anthony Nolan, Novavax, coronavirus shot data in hand, strikes an eye-popping supply deal with global vaccine consortium, and Novartis partners with Bill & Melinda Gates Foundation on ‘accessible’ sickle cell gene therapy.

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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

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

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 Secret Ingredient in Your Gene Therapy Success Recipe

In this podcast, we talk with Ratish Krishnan, Associate Director for Cell & Gene Therapy BioProcessing for the Americas with MilliporeSigma about the tremendous promise gene therapies have for changing the healthcare paradigm, challenges in manufacturing and solutions…

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:

“White House to roll out Johnson & Johnson vaccine doses next week, pending authorization,” Reuters

The United States expects to roll out three to four million doses of Johnson & Johnson’s COVID-19 vaccine next week, pending authorization from the Food and Drug Administration, White House COVID-19 response coordinator Jeff Zients said on Wednesday…

“EU regulator says Celltrion’s COVID-19 antibody drug under real-time review,” CNN

Europe’s drug regulator said on Wednesday it was evaluating South Korean drugmaker Celltrion’s COVID-19 antibody treatment, the third such drug against the disease to go under real-time review in the region. The European Medicines Agency (EMA) said its human medicines committee was assessing the first set of data it received from animal and human trials of the drug, regdanvimab, and will continue to study them as more data was submitted…

“U.S. poised to have 3M vaccine doses available per day by April,” Politico

The United States is on track to have three million coronavirus vaccine doses per day available by April, according to numbers shared by major manufacturers in a congressional hearing Tuesday. Vaccine providers including Pfizer and Moderna, makers of already authorized shots, appeared before a House panel just before an influx of shots could arrive in federal coffers. Pfizer said Tuesday that it can bump supplies from four to five million shots a week currently to 13 million doses per week by mid-March, while Moderna said it can double its supplies to provide more than 40 million doses per month by April…

“FDA says Covid vaccines that target new variants won’t need large clinical trials to win approval,” CNBC

The Food and Drug Administration said Monday that modified Covid-19 vaccines against new, emerging variants may be authorized without the need for lengthy clinical trials. The new guidance, released in a 24-page document on the FDA’s website, would clear the new vaccines as an amendment to a company’s originally approved emergency use application, according to the FDA. The company would need to submit new data that shows the modified vaccine produces a similar immune response and is safe, similar to the process for annual flu vaccines…

“ONK Therapeutics enters collaboration with blood cancer charity Anthony Nolan,” PharmaTimes

ONK Therapeutics has announced a new collaboration with blood cancer charity Antony Nolan, with the aim of accelerating the development of next-generation natural killer (NK) cell therapies. The collaboration will focus on facilitating the development of NK cell therapies for patients with haematological malignancies and solid tumours…

“Novavax, coronavirus shot data in hand, strikes an eye-popping supply deal with global vaccine consortium,” FiercePharma

COVID-19 vaccine maker Novavax has at times flown under the radar as some of the world’s leading drugmakers dominated headlines and raced toward rollouts. But an eye-popping new supply deal with international players is sure to turn heads. Novavax on Thursday unveiled a memorandum of understanding with Gavi, the Vaccine Alliance, to provide 1.1 billion doses of its coronavirus vaccine candidate to COVAX, a global effort to ensure equitable vaccine distribution. The Serum Institute of India will help produce doses under a prior deal between that company and Gavi…

“Novartis partners with Bill & Melinda Gates Foundation on ‘accessible’ sickle cell gene therapy,” PMLive

Swiss pharma company Novartis has entered into an agreement with the Bill & Melinda Gates Foundation for the discovery and development of an ‘accessible’ gene therapy for sickle cell disease (SCD). The Gates Foundation will provide funding support for the discovery and development of a single-administration, in vivo gene therapy with the aim of curing SCD. Current gene therapies in clinical testing for SCD work by taking cells from a patient that are then altered in a laboratory and reintroduced to the patient in a process similar to a bone marrow transplant…