This week’s headlines include: Covid-19: Pfizer/BioNTech vaccine judged safe for use in UK, Deliver a safe, effective COVID-19 vaccine in less than a year? Impossible. Meet Moncef Slaoui. Moderna CEO expects emergency use nod for COVID-19 vaccine shortly after FDA’s December 17 meet, Vectura, Kinaset Therapeutics set to develop inhaled asthma drug, Astra Eyes Extra Global Vaccine Trial as Questions Mount, Canada blocks bulk exports of some prescription drugs in response to Trump import plan, and Novartis signs $50 million deal for Mesoblast cell therapy for COVID, beyond.

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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:

Platform Approach to Accelerating Cell Line and Process Development

As a result of the desire for speed to market, companies are looking for ways to simplify and speed cell line development and process development. For instance, ensuring that more there are more high producing clones. Additionally, optimizing a production platform and selecting clones that perform well in this platform is more efficient than building a process around each clone…

Cool Tool – DASbox Mini Bioreactor System’s small working volumes and advanced control options offer a versatile solution for advanced process development experiments

Process development and optimization is a critical aspect of manufacturing for both cell culture and microbial-based systems. The challenge is often creating conditions in process development that match the conditions found in manufacturing. To fully optimize a process, it is important to be able to run multiple experiments at the same time in order to fully assess the best conditions. A Design of Experiments (DoE) provides an efficient and thorough look at a wide variety of conditions, but in order to fully utilize this tool, you must be able to conduct experiments in parallel. If not, the time and resources required would make DoE not feasible in many situations. If done properly, a good process development strategy can shorten a product’s time to market…

Ask The Expert – Plasmid DNA Production for Cell and Gene Therapy

High-quality plasmid DNA is a key component in cell and gene therapy manufacturing and as such is in high demand. This has led to the need to optimize manufacturing to meet the demand for volume as well as the quality required for use in the manufacture of therapeutics. Plasmid DNA (pDNA) manufacturing faces several challenges due to its large size, shear sensitivity, high viscosity, and the similarities between the pDNA and the impurities present during manufacturing. Thus, understanding all areas of the process are critical to successful manufacturing at a large scale. With the high demand and quality requirements, it is important to seek out experts in the field who can illuminate the critical optimization opportunities for pDNA and answer questions about the production. For this Ask the Expert Session, we assembled a team of experts to answer questions on plasmid DNA production for cell and gene therapy applications…

New Lab Set Up – Best Practices for a Successful Start

In this podcast, we spoke with Dr. Ann Rossi Bilodeau, Senior Bioprocess Applications Scientist and Dr. Catherine Siler, Field Applications Scientist both with Corning Life Sciences, who shared insightful tips for setting up a new lab. We discussed how to create a lab plan, maximize lab space, stay within budget and timelines. They also shared their experience in implementing lab safety and training as part of the new lab launch…

Ask the Expert – Viral Vector Manufacturing

Viral vector manufacturing is a critical part of most gene therapy and gene-modified cell therapy production processes. The Lentiviral vector is a commonly used vector for CAR T gene-modified cell therapies and has been key in the advancement of these therapies. In addition, Lentiviral vectors are also used in gene therapies to treat several genetic diseases. With the importance of these vectors to production, there has been a need to improve manufacturing processes. Areas for improvement include stable cell line development, scalability, upstream and downstream process optimization, and ensuring that a production process is ready for gene therapy commercialization. It is great to have expert help to navigate these opportunities for process improvement. For this Ask the Expert Session, we assembled a team of experts to answer questions on viral vector manufacturing and process improvement…

When to Choose Agarose or Methacrylic Polymer Resins– Frequently Asked Questions

Over the past decade we have seen an increase in the resin options available for chromatography. These new resins have different chemical compositions and molecules access them differently. Thus, they provide a more “fit for purpose” solution, especially for emerging therapeutics. While the increased choices are great for purification efficiency, it can sometimes be difficult to navigate the resins available, the different grades, and what each are best suited for…

Single-Use Tangential Flow Filtration (TFF) Offers Advantages for Viral Vectors and Vaccines

The advantages of single-use systems have been well documented in biomanufacturing for over a decade and are frequently used in the manufacture of monoclonal antibodies. Key areas where single-use systems provide real benefit over stainless steel counterparts is in reducing production change-over time and decreasing the cleaning and validation that requires significant time, labor, water and utility costs. Single-use systems also enable flexible facilities, require less capital investment and are quicker and easier to initiate than stainless steel facilities. These technologies are also often compatible with process automation…

Combining Ion Exchange and Reverse Phase Chromatography for Highly Efficient and Cost Effective Peptide Purification

Therapeutic peptide purification can be very challenging because of the similarities between peptides and their impurities. There is not a significant difference in retention for the target peptide and a peptide contaminant that has one amino acid that is different. Thus, separation of peptides from by-products requires long retention times that are inefficient. In addition, even small changes in the mobile phase composition can cause significant effects. One way to increase the separating power of RP-HPLC is to make use of an ion-pairing agent, which couples with basic amino acids, resulting in a net zero charge. Generating a net zero charge status enables separation using a reverse phase process. However, the duel reverse phase process can be cost prohibitive for peptides that require a high level of purity…

Strategies for Increasing Productivity and Reducing Cost of Chromatography in mAb Biomanufacturing

Increasing upstream titers, the need to increase throughput of existing facilities and the desire to reduce costs are just a few of the drivers forcing paradigm shifts in monoclonal antibody (mAb) downstream processes. These drivers are acutely felt in the selection of chromatography resins, as the purification step is often the source of bottlenecks and is costly…

Headlines:

“Covid-19: Pfizer/BioNTech vaccine judged safe for use in UK,” BBC

“Moderna CEO expects emergency use nod for COVID-19 vaccine shortly after FDA’s December 17 meet,” Reuters

Moderna Inc’s COVID-19 vaccine could be approved for emergency use within 24 to 72 hours after the U.S. health regulator’s advisory committee meeting, Chief Executive Officer Stéphane Bancel said on Wednesday. The Food and Drug Administration is scheduled to hold the meeting on Dec. 17 to discuss the company’s request for emergency use authorization for its vaccine…

“Vectura, Kinaset Therapeutics set to develop inhaled asthma drug,” PharmaTimes Online

UK-based Vectura Group has signed an agreement with Kinaset Therapeutics to develop and commercialise a preclinical inhaled pan-JAK inhibitor for the treatment of severe asthma. Under this agreement, the therapeutic candidate – VR588 – will be taken into phase I studies, with the goal of advancing the drug through to commercialisation…

“Astra Eyes Extra Global Vaccine Trial as Questions Mount,” Bloomberg

AstraZeneca Plc’s Covid-19 vaccine looks like it’s headed for an additional global trial as the drugmaker tries to clear up uncertainty and confusion surrounding favorable results in its current study. The company wants the new test to confirm the 90% efficacy rate that the shot showed in a portion of an existing trial, Chief Executive Officer Pascal Soriot said. It’s favoring that option rather than adding an arm to a separate study that’s already underway in the U.S…

“Canada blocks bulk exports of some prescription drugs in response to Trump import plan,” Reuters

Canada on Saturday blocked bulk exports of prescription drugs if they would create a shortage at home, in response to outgoing U.S. President Donald Trump’s efforts to allow imports from Canada to lower some drug prices for Americans. “Certain drugs intended for the Canadian market are prohibited from being distributed for consumption outside of Canada if that sale would cause or worsen a drug shortage,” Health Minister Patty Hajdu said in a statement…

“Novartis signs $50 million deal for Mesoblast cell therapy for COVID, beyond,” Reuters

Novartis NOVN.S aims to boost its respiratory treatment portfolio with a $50 million deal for an off-the-shelf cell therapy from Mesoblast MSB.AX that it hopes to deploy for COVID-19 patients as well as others suffering from respiratory distress. The Swiss drugmaker’s deal with Australia-based Mesoblast secures rights to develop, commercialize and manufacture Remestemcel-L for treating acute respiratory distress syndrome (ARDS), including that associated with COVID-19, for which the therapy is currently in late-stage trials…