This week’s headlines include: EU plans to boost reach of Pfizer COVID-19 shot, FDA advisory panel scheduled to discuss Merck COVID-19 antiviral pill, Biden zeroes in on Califf to head FDA as deadline nears, FDA clears Keytruda for first-line cervical cancer, VCs back Leucid to trial CAR-T twist in ovarian cancer patients, and Continuous manufacturing bill clears House.

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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:

Gaining Real Time Bioprocess Insights Using Raman Spectroscopy

Mammalian cell culture is an integral part of biopharmaceutical manufacturing, but in-process monitoring strategies often lack real-time measurements. Unfortunately, the process mostly remains a highly manual low-throughput process that can increase the risk of batch contamination. Advances in process analytical technology (PAT) have surged because of industry-wide adoption of Quality by Design (QbD) principles. QbD seeks to build the quality of a product into the manufacturing process itself rather than simply relying on end-product testing. PAT plays an integral role in QbD since it can provide important metrics during the manufacturing run for bioprocess insight. These metrics not only ensure consistent product quality but can also inform strategies to increase throughput and introduce automation to build efficiency throughout the workflow…

Selecting the Appropriate Scaling Strategy for Different Cell Therapy Applications

Cell therapies represent a new paradigm in medicine, and the commercialization of several treatments has prompted a need for those developing these therapeutics to look at the scalability of their manufacturing platforms. The decision on how to scale-up and scale-out while choosing the appropriate platform and associated technology relies heavily on the therapeutic being manufactured. Because the cells are the therapeutic product, they need to retain their phenotype and functionality regardless of the manufacturing method. Utilization of primary cells to develop these therapeutics presents unique challenges. These include addressing issues such as donor variability, increased sensitivity to changes in their environment and downstream considerations for formulation and final fill…

Cell Culture Media Analysis in Upstream Biologics Development

A strong cell culture media development and optimization program is key to successful manufacture of any cell-based biologic. Effective media development and optimization programs require substantial data about how cells respond to varying aspects of media composition, feed strategies, gas exchange and several other factors. Strong analytics are the foundation for this information and cell culture media analysis provides key insights into the health and productivity of cells in culture and intelligence on what components cells need, which have negative impacts, and how these components are ultimately utilized by the cells…

Media Optimization for Cell Therapy Production

In cell-based therapies, the cultured cells are the therapeutic product, which necessitates different manufacturing processes as compared with other biologics productions. As a cell therapy developer, the big considerations in the scale-up process include the input cells, culture vessels, and culture media. Inadequate consideration and planning can not only impact the efficacy of the cell therapy, but also present costly regulatory roadblocks that can delay progress through the product pipeline. Since the culture media is linked to the growth and productivity of the cells, it is one of the most critical aspects of process development during scale-up…

Utilizing Optimized Protein Expression Systems to Advance Development of Therapeutics Against Infectious Diseases

The rapid emergence and spread of novel infectious diseases such as COVID-19 caused by the SARS-CoV-2 virus has highlighted the need for innovative protein expression solutions to support rapid and comprehensive virus characterization, serological testing, therapeutic antibody and vaccine development to mitigate these threats to global health. A recent white paper published by Thermo Fisher Scientific entitled Advancing the development of therapeutics against infectious diseases with optimized protein expression systems highlights how their comprehensive portfolio of mammalian and insect transient protein expression systems can accelerate and streamline infectious disease research and meet high-yield bioproduction requirements for the development of diagnostics and therapeutics that can mitigate virus spread…

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…

Evolving Beyond the Status Quo with Next Generation Buffer Prep Solutions

In this podcast, we spoke with Chris Rombach, Vice President of Sales and Marketing at Asahi Kasei Bioprocess America about buffer prep and delivery systems. We discussed current pain points and how next generation buffer prep solutions can greatly improve upon the status quo, including increasing the use of automation and remote operation, while reducing the overall footprint, labor and cost associated with more traditional approaches…

Integrated Freezing Solutions to Minimize Risk and Preserve Product Quality

In this podcast, I talked with Claire Jarmey-Swan, Global Product Manager, Pall Corporation about the evolution of freeze-thaw technologies and how these new methods can streamline the process, minimize loss and maintain the highest product quality…

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…

Headlines:

“EU plans to boost reach of Pfizer COVID-19 shot,” Reuters

Europe’s drug regulator said on Monday it was evaluating use of the Pfizer-BioNTech COVID-19 vaccine in children as young as five, while also taking steps to aid an increase in production and boost the shot’s reach…

“FDA advisory panel scheduled to discuss Merck COVID-19 antiviral pill,” The Hill

The Food and Drug Administration (FDA) scheduled a meeting for late next month for its advisory panel to discuss Merck’s antiviral pill designed to treat mild-to-moderate COVID-19. The medication could be a game changer in the U.S.’s fight against the virus. The federal agency announced on Thursday that the advisory committee will meet on Nov. 30 to review data on molnupiravir. If approved, the oral pill would be given to adults who recently tested positive for COVID-19 and are at high risk of severe illness, hospitalization and death…

“Biden zeroes in on Califf to head FDA as deadline nears,” The Washington Post

The White House is closing in on former Food and Drug Administration commissioner Robert M. Califf as its choice to serve again as agency chief, according to five people who spoke on the condition of anonymity to detail the discussions…

“FDA clears Keytruda for first-line cervical cancer,” PharmaTimes

MSD’s PD-1 inhibitor Keytruda (pembrolizumab) has received approval from the US Food and Drug Administration (FDA) for the first-line treatment of certain cervical cancer patients…

“VCs back Leucid to trial CAR-T twist in ovarian cancer patients,” FierceBiotech

John Maher, Ph.D., has secured funding to put his ideas about CAR-Ts to the test. As chief scientific officer of Leucid Bio, Maher has pushed the idea that the configuration of co-stimulatory modules is the secret to success in CAR-T—and now he has the cash to run a phase 1 clinical trial in ovarian cancer…

“Continuous manufacturing bill clears House,” Regulatory Focus

The US House of Representatives on Tuesday night passed a bill, H.R. 4369, that promotes advanced manufacturing through the creation of national centers for excellence in continuous manufacturing at various universities across the country. The House also passed another bill, H.R. 3635, which would make changes to the management of the Strategic National Stockpile to help the response to the current pandemic and future public health emergencies by allowing transfers of supplies to other federal departments or agencies and by temporarily authorizing the Department of Health and Human Services to award grants to states to maintain their own stockpiles during emergencies…