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 Conferences:

Cell Therapy Manufacturng and Gene Therapy Congress

October 19-22, 2020

World renowned leaders share the latest analytical techniques & vector technologies to revolutionize your cell, gene & gene edited ex vivo cell therapy programs. For 2020, we have decided to combine our EU and US meetings into one GLOBAL virtual event. Redefining your learning experience and bringing the content you want, when you want it.

Cell Culture Dish Readers can get 20% off by using this link and the code CELLDISH20

https://informaconnect.com/cell-therapy-bioprocessing/purchase/select-package?vip_code=CELLDISH20

The Cell Culture Dish is presenting a panel discussion in the on Demand section – “Insights on Successful Gene Therapy Manufacturing and Commercialization.”

Please check it out!

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

Developing scalable upstream workflows for recombinant and viral vaccine processes
Tuesday, Oct 20 – 08:00 PDT | 11:00 EDT | 16:00 BST | 17:00 CEST
Thursday, Oct 22 – 08:00 CEST | 11:30 IST | 14:00 SGT | 15:00 JST

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:

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….

GMP-Compliant Benzonase® endonuclease Safety Plus Emprove® Expert Provides Enhanced Risk Mitigation

Benzonase^® endonuclease has been used in biopharmaceutical production for DNA removal for over 30 years. It is a genetically engineered endonuclease, from Serratia marcescens, which can completely hydrolyze all forms of DNA and RNA (single-stranded, double-stranded, linear, and circular) into smaller oligonucleotides (<6 kDa) with no base preference. The use of Benzonase^® endonuclease for downstream virus purification improving speed of purification, protects the downstream chromatography and filter devices from fouling, and give better product purity and yield while also meeting regulatory requirements…

Modernize Your Cell Development Assays with High-Throughput Image Cytometry

Cell line development encompasses an optimized process that balances cell line productivity and cell product quality over a consistent and reproducible timeline. This article summarizes areas of cell line development where image cytometry has provided workflow advantages and made the entire process more efficient…

Reducing Fill Risk in Drug Product Manufacture Utilizing New State-of-the-Art Systems and Platforms

In this podcast we talked with DQ Wang, PhD, and Vice President, Formulation, Fill and Finish of WuXi Biologics about their DP4 multi-product fill & finish facility featuring the Vanrx SA25 robotic, gloveless, isolator-based filling system. The system significantly reduces drug product fill risk and provides greater aseptic assurance. The facility is the first in China to use this technology platform and the system fits perfectly with “scale-out” manufacturing paradigms. This highly-flexible platform can easily transition between various Container Closure Systems (CCS) such as vials, pre-filled syringes and cartridges including the new Ready-To-Use (RTU) formats…

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. government signs deal to make more COVID-19 vaccine components,” Reuters

The U.S. government has entered an agreement with life sciences company Cytiva, a unit of Danaher Corp, to expand the manufacturing of products needed to make COVID-19 vaccines, the U.S. Department of Health and Human Services (HHS) said on Tuesday. Under the deal, Cytiva will receive about $31 million to scale up manufacturing of vaccine-related products, including cell cultures and hardware such as bioreactors used for the culturing of cells and antibodies…

“Eli Lilly pauses study of COVID-19 treatment over safety concerns,” The Hill

Eli Lilly’s late-stage clinical trial of a monoclonal antibody treatment for COVID-19 has been paused by federal regulators due a safety concern, the company said Tuesday. “Safety is of the utmost importance to Lilly. We are aware that, out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” spokeswoman Molly McCully told The Hill in an emailed statement…

“Pfizer to enroll kids as young as 12 in COVID-19 vaccine study,” Reuters

Pfizer Inc will enroll participants as young as 12 in its large, late-stage COVID-19 vaccine trial to understand how it works in a wider age group. The U.S. Food and Drug Administration granted permission to the drugmaker and German partner BioNTech SE to enroll the younger participants this month, according to an update on Monday on the U.S. company’s website here…

“CHO Cell Culture Media & Feeds – Selecting The Right Media,” Bioprocess Online

Media selection is a crucial step in optimizing and maximizing your upstream process. Mixing media and feeds can be a strategy in fed batch to increase output of your target molecule…

“Moderna Vows to Not Enforce Covid-19 Vaccine Patents During Pandemic,” Wall Street Journal

Moderna Inc. said it wouldn’t enforce patents related to its experimental Covid-19 vaccine while the pandemic continues and is willing to license the patents to others after the pandemic…

“Uni of Manchester partners with AVROBIO for Hunter syndrome gene therapy,” PharmaTimes Online

The University of Manchester in the UK has partnered with US-based biotech AVROBIO on the clinical development of an investigational gene therapy for mucopolysaccharidosis type II (MPS II), or Hunter syndrome. Under the terms of the partnership, the University will sponsor the investigator-led phase I/II trial for Hunter syndrome which is expected to begin in 2021…