This week’s headlines include: U.S. government signs deal to make more COVID-19 vaccine components, Eli Lilly pauses study of COVID-19 treatment over safety concerns, Pfizer to enroll kids as young as 12 in COVID-19 vaccine study, CHO Cell Culture Media & Feeds – Selecting The Right Media, Moderna Vows to Not Enforce Covid-19 Vaccine Patents During Pandemic, and Uni of Manchester partners with AVROBIO for Hunter syndrome gene therapy.

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

Upcoming Webinar:

Stem cell derived exosome production in stirred-tank bioreactors

Exosomes are a population of naturally occurring mobile, membrane-limited, 30 – 100 nm in diameter, extracellular vesicles containing a large number of proteins, lipids, messenger, and micro-RNAs. It was shown that they play a role in the mediation of intercellular communication, the modulation of immune-regulatory processes, tumor metabolism, and regenerative as well as degenerative processes. In recent years, there is increasing interest in the therapeutic potential of exosomes produced by Mesenchymal Stem Cells (MSCs).

Stirred-tank bioreactors offer the possibility to tightly control and monitor the production of exosomes, as well as the scalability, to produce increasing amounts. However, the cultivation of stem cells in stirred-tank bioreactors requires profound knowledge and precise control of the process.

In our talk, we will highlight the potential and benefits of stirred-tank bioreactors in the cultivation of stem cells for exosome production. We will share our knowledge on how we developed the process in our DASbox® Mini Parallel Bioreactor System and scaled-up the process to 1 L controlled by our newest parallel bioreactor control system, the SciVario® twin.

Register Here

Virtual Symposium:

Approaches and tools for maximizing success on the journey from discovery to the clinic

October 27, 2020 – 8:30-1:10 Eastern Time

A complimentary virtual symposium hosted by the MassBioHub on October 27th to provide insight from experts in the different approaches and techniques to successfully progress biotherapeutic candidates from discovery to the clinic. Hear about updates on enhancements to new and established technologies enabling translational research. The day includes talks from industry experts, local biotech companies and technical specialists from Lonza.

Register Here

Webinar Series:

Vaccine Production: Securing Process Quality with Flexible Manufacturing Solutions

Downstream process development for vaccine manufacturing
Tuesday, Nov 03 – 08:00 PST | 11:00 EST | 16:00 GMT | 17:00 CET
Thursday, Nov 05 – 08:00 CET | 12:30 IST | 15:00 SGT | 16:00 JST

Implementing single-use technologies in formulation and filling of vaccines
Tuesday, Nov 17 – 08:00 PST | 11:00 EST | 16:00 GMT | 17:00 CET
Thursday, Nov 19 – 08:00 CET | 12:30 IST | 15:00 SGT | 16:00 JST

Attendees will get a critical look at the vaccine industry today, its globalization and how the cost of a vaccine is assessed. Different types of vaccine production processes, equipment, and activities will be reviewed with examples from influenza and inactivated polio vaccine manufacturing. Upstream cell expansion and antigen production, and downstream chromatography, inactivation, and formulation and filling will be explored. Strategies and philosophies for process optimization, safety, and quality—including the importance of QbD and final product sterility assurance and delivery—will also be studied.

To attend any of the webinars above, please visit Vaccine Production: Securing Process Quality with Flexible Manufacturing Solutions

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

Successful Techniques for Progressing Biotherapeutic Candidates from Discovery to the Clinic

The reality is that many initially promising biotherapeutic candidates never make it to commercialization. It is estimated that only 1 in 1000 preclinical candidates reach the commercial market. Why does this happen? There are many that fail due to lack of efficacy or safety, but there are also candidates that fail due to stability, aggregation, and other issues related to cell line or process issues. While some issues may never be satisfactorily resolved to the point where commercialization is possible, others can be saved with early identification, engineering and process development approaches. Even for candidates that can’t be rescued, it is critical to know this early, so that time and resources aren’t wasted on a product that ultimately has no path forward. Therefore, it is imperative that strategies and technologies are available to evaluate and identify issues early in the development phase and address challenges where possible…

Viral Vector Process Intensification: Stepwise Model for Efficient Scale-up

The unprecedented clinical success of novel cell and gene therapies (CGT), such as CAR-T cell therapy, has led researchers to shift from treating more rare conditions present in smaller populations to those more prevalent in the general population. This has, in turn, resulted in a growing market demand for the viral vectors used in these therapies. It has highlighted the need to increase manufacturing capacity to meet market demands by developing scalable and cost-effective viral vector manufacturing processes and improving methods for purification and analysis to ensure product purity, efficacy, and safety. Research and Markets recently reported the global viral vector manufacturing market was valued at US$459.4 million in 2019 and – expected to reach US$2.2 billion by 2027…

The Rotea Counterflow Centrifugation System Offers a Versatile, Closed System Solution for Cell Therapy Processing

Cell therapy processing requires multiple steps and procedures including cell separation, concentration, washing and others. For a successful cell therapy process, it is important to be able to conduct these activities as simply, safely and efficiently as possible. To improve the efficiency of cell processing operations, Thermo Fisher Scientific launched the multipurpose Gibco™ Cell Therapy Systems (CTS™) Rotea™ Counterflow Centrifugation System. The system uses a closed single-use kit to allow smooth transition from research through commercial manufacturing…

Demystifying the FBS Selection Process – A guide for evaluating product quality, origination and cost consideration

In this podcast, we talked with Chris Scanlon, Global Marketing Development Manager at Thermo Fisher Scientific about how to effectively evaluate which FBS product is right for each application. This includes weighing product quality levels and country of origin. Chris also shares strategies for maximizing purchasing options and new FBS products on the horizon…

Flexible Platform Solutions Overcome Vaccine Production Challenges

In this guest article from Pall Biotech the challenges of vaccine development and how they can be overcome by applying a quality by design (QbD) platform approach from early process development phases forward are explored. The impact of the COVID-19 pandemic on vaccine production is evaluated, with insight on how flexible, integrated, closed-system processing is advancing the future of safe and efficacious vaccine production….

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…

Cool Tool – Cellulose Fiber-based Chromatography Increases Flexibility and Throughput in Antibody Purification

Recent industry initiatives have put increased emphasis on improving the flexibility and throughput of biomanufacturing processes. To achieve this, new technologies are required that permit faster process times and increased flexibility for a variety of manufacturing scenarios including smaller batch sizes and multi-product facilities. One critical aspect of the biomanufacturing process is downstream chromatography purification and this can often be a time and resource intensive step…

Innovative Single-Use Freeze and Thaw Platform for Bulk Drug Substance

Successful bulk drug substance freeze and thaw is a critical aspect of biologics manufacturing. It is also time consuming and labor intensive. Historically, cryovessels have been the most common technology used for freeze and thaw due to their durability and scalability. However, cryovessels require extensive cleaning processes and infrastructure and labor to maintain them. These challenges, led companies to look for single-use alternatives. While single-use significantly reduces cleaning requirements, they are difficult to scale due to limitations of the size of the bags. Another downside is that they can be prone to integrity issues…

Headlines:

“U.S. likely to have enough COVID-19 vaccines for all vulnerable Americans by year end: official,” Reuters

The United States is likely to have enough safe and effective COVID-19 vaccines available to inoculate the most vulnerable Americans by the end of 2020, Health and Human Services Secretary Alex Azar said on Wednesday. The U.S. government is “cautiously optimistic” that one or two vaccines, likely from Pfizer Inc or Moderna Inc, will be available by the end of the year and can begin to be distributed to Americans, officials said during a news conference…

“Rheumatoid arthritis drug tocilizumab advances as a COVID-19 treatment, as other regimens fall back, studies show,” USA Today

The list of drugs shown effective for treating COVID-19 got longer Tuesday, even as another well-used drug lost some of its luster. In a large clinical study, tocilizumab, an immune modulator long used to treat rheumatoid arthritis, showed it can save lives if given to critically ill COVID-19 patients within the first two days of being admitted to an intensive care unit…

“U.S. FDA meeting on COVID-19 vaccines to discuss criteria for emergency nod,” Reuters

The U.S. health regulator’s criteria for allowing emergency use of a COVID-19 vaccine and plans to monitor its safety after a regulatory go-ahead, are among the topics to be discussed at a closely watched meeting scheduled for Thursday. Details posted on the Food and Drug Administration’s (FDA) website showed the U.S. Centers of Disease Control and Prevention has formulated plans to monitor safety and effectiveness of a vaccine even after the FDA allows for its emergency use…

“BARDA taps Beckman Coulter to develop a blood test for MIS-C, the severe childhood illness linked to COVID-19,” FierceBiotech

While most children may only show mild symptoms after exposure to the novel coronavirus, some develop severe, life-threatening complications that can attack several organs at once. Known as Multisystem Inflammatory Syndrome in Children, or MIS-C, it can affect the heart, lungs, kidneys, brain, skin and eyes. But there’s an obstacle before they can receive effective treatment: the disease’s earliest signs include fever and a rash—symptoms shared with many common childhood illnesses or colds…

“France’s Ose to enrol up to 400 for ‘T-cell’ coronavirus vaccine trials,” Reuters

France’s Ose Immunotherapeutics will enrol up to 400 patients for the first two stages of clinical trials of an experimental coronavirus vaccine it hopes will provide an extra weapon in battle against the global pandemic…

“State health officials tell Congress they need $8.4B for COVID-19 vaccination effort,” The Hill

State public health officials are urging Congress to provide at least $8.4 billion in emergency funding for distributing a coronavirus vaccine, warning that they do not currently have enough money to carry out the immense logistical effort.  The letter to bipartisan congressional leaders came from the Association of State and Territorial Health Officials (ASTHO), a group that represents state public health departments, and the Association of Immunization Managers (AIM), which represents states’ vaccination officials…

“Roche signs deal with Dyno Therapeutics for gene therapy vectors,” PharmaTimes Online

Roche has signed a collaborative agreement with Dyno Therapeutics for the development of adeno-associated virus (AAV) vectors for gene therapies for central nervous system (CNS) disease and liver-directed therapies. Under the terms of the agreement, Dyno will design novel AAV capsids with improved functional properties for gene therapies, while Roche and its subsidiary Spark Therapeutics will be responsible for preclinical, clinical and commercialisation activities for gene therapy product candidates using the novel capsids…