This week’s headlines include: Amgen’s Repatha gains an edge on rival Praluent with FDA approval to treat children with rare cholesterol condition, Pfizer submits data on Covid-19 vaccine for kids ages 5 to 11 to FDA, not seeking EUA yet, FDA official taking on responsibilities to lead vaccine office, Pfizer begins study of oral drug for prevention of COVID-19, AstraZeneca invests in Imperial’s self-amplifying RNA technology with eye on future drugs, COVID creates shortages of an array of U.S. medical supplies, and Biden doubles US global donation of COVID-19 vaccine shots.

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

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

Hassle-free nanoparticle characterization with Stunner

The use of nanoparticles in medicine offers exciting new possibilities to deliver RNA, DNA, and protein payloads with more diverse therapeutic applications than ever before. Notably, lipid nanoparticle carriers are integral to the success of the COVID-19 messenger RNA (mRNA) vaccine aimed at activating immune cells against the SARS-CoV-2 virus. The diversity of potential payloads and applications has led to the creation of many forms of organic nanoparticles and includes liposomes, lipid nanoparticles (LNP), solid lipid nanoparticles, nano-emulsions, polymeric lipid nanocarriers and other proprietary or specially formulated particles for targeted delivery…

The Evolution of Cell Therapy Manufacturing: Part II – A Promising Future

In Part I the rather wide spectrum of medical treatments referred to as Cell Therapy was introduced.  This diversity includes the proximate source of the cells, the cell type, any activation or engineering required, the mode of cell culture, and the therapeutic indication. Processes in the early days of adoptive transfer therapies, such as Rosenberg’s in-house produced TIL were described.  That outline presented current practices, general facility requirements, equipment currently employed, and examples of newly commercialized cell therapy (CT) equipment including those providing semi-automated and locally closed processing…

Implementing Adherent Cell Culture Technology for Cell Therapy Bioprocess

In this panel discussion podcast and article we discuss adherent cell culture for cell therapy production, including cell therapies that are a good fit for adherent cell culture, scale up processes, and the future of cell therapy manufacturing…

Rethink T Cell Therapy with Lipid Nanoparticles

Gene-modified cell therapy has historically been achieved using viral vectors for ex vivo gene delivery, with approved drugs such as Kymriah^® or Yescarta^® demonstrating the success of autologous cell therapies. However, both safety concerns and the difficulty of working with viruses have led many to desire alternatives. Non-viral methods such as electroporation are being explored as alternatives, but electroporation can lead to low cell viability and is not straightforward to scale up…

Microfluidic Transfection Device is Poised to Remove Current Transfection Limitations for Gene Therapy Applications

The transfer of materials into cells via transfection is a critical operation of manipulation and engineering of cells. DNA is often used as the cargo for transfer; however, other cargos may include RNA, proteins, small molecules, and ribonucleoproteins, such as those used in the engineering of cell therapy products. Even though cell transfection was initially developed decades ago, challenges remain with the process. Current methods may damage cells, require special reagents, that may be mixing and time dependent, and often inefficient. Performance may suffer since many approaches rely on the passive diffusion of material into cells, usually though temporarily, induced holes in the cell membrane. These challenges, in turn, create burdens in many areas of current biomanufacturing such as manufacturing at scale or in the development of complex, multiple gene-edited cell-based therapeutics.

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…

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…

Headlines:

“Amgen’s Repatha gains an edge on rival Praluent with FDA approval to treat children with rare cholesterol condition,” FiercePharma