This week’s headlines include: GenSight Biologics seeks EU approval for gene therapy, Lonza works with Humanigen on COVID-19 drug candidate lenzilumab, Univercells Introduces NevoLine Upstream Platform, Moderna Shares the Blueprint for Its Coronavirus Vaccine Trial, China starts testing nasal spray coronavirus vaccine, and NIH chief, surgeon general vow ‘science alone’ will guide vaccine.

Podcasts:

Check out our podcast channel. We have over 40 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:

BioProcess International – Virtual

September 21-25, 2020

The largest virtual bioprocessing event bringing you the science, technologies and partners needed to accelerate promising biologics towards commercial success. Improve efficiencies across the entire spectrum of biopharmaceutical development and production – all from the comfort of your home!

Cell Culture Dish Readers register at this link to get a 20% discount or a free exhibition hall pass!

Cell Series UK

October 6-7, 2020

Join over 800 scientific leaders at the flagship Cell Series UK, connecting regenerative medicine and bioprocessing experts to transform cell research and therapies

The Cell Culture Dish will be presenting a panel discussion on Gene Therapy Manufacturing, stay tuned for more details.

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 will be presenting a panel discussion on Gene Therapy Manufacturing, stay tuned for more details.

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

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…

The Challenge of Staying Current with Regulatory Changes – How one company is providing a solution

In this podcast, we talked with Ken Chen, MBA, Senior Director, Regulatory Affairs, WuXi Biologics about staying current with regulatory changes. We discussed how WuXi Biologics recently began publishing a quarterly summary of regulatory updates on new or revised guidance documents from the various global regulatory agencies and how this is a valuable resource for anyone in the biological drug development arena…

Best Practices for Successful Technology Transfer

Technology transfer is a critical aspect of moving a biologic from discovery to commercial manufacturing. Ideally, there is a clear plan for technology transfer that results in a successful final process. However, most have experienced situations where the transfer of processes causes significant bottlenecks. These bottlenecks can happen when technology is transferred from client to partner as well as the transfer of the final process from partner back to client. It can also happen internally when technology is transferred between company departments…

Computer Aided Biology Platform Helps Companies Meet the Challenges of 21st Century Biomanufacturing

In this podcast, we interviewed Markus Gershater, Chief Scientific Officer with Synthace about computer aided biology and how it addresses several common biomanufacturing challenges. We also discussed ways to build a common culture between science and software…

ExpiSf™ Baculovirus Expression System Demonstrates High Yield Protein and Viral Vector Production from Micro to Large Scale

Effectual protein and viral vector production requires selection of a versatile and highly productive expression system. The insect based Baculovirus Expression Vector System (BEVS) has shown its utility in large-scale production of both proteins and viral vectors. A recent poster, Scalable protein and AAV production in the ExpiSf™ Expression System, demonstrates the use of the Gibco™ ExpiSf™ Expression System for high-yield production of proteins and viral particles with consistent performance using a fast, streamlined workflow. The system demonstrates scalability for production in stirred tank, rocking motion, and microbioreactors. Optimal bioprocessing parameters and protocols to enable high quality process development for production of targets of interest are described…

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…

Top Downstream Process Articles of 2019

Don’t miss our top articles on downstream processing for 2019! I have compiled a list of our most popular articles from 2019 in alphabetical order…

Automated Buffer Preparation – Increasing Production Capacity While Maintaining Footprint

Buffer preparation requires extensive footprint and is also resource-intensive. In fact, it is known to be one of the most resource-intensive activities in biomanufacturing as large volumes of buffers and process liquids are often required as production capacity increases. Thus the question exists how can buffer preparation be more efficient and not require footprint expansion. Is there a way to increase manufacturing capacity without increasing footprint and time spent on buffers? One possible solution is automating buffer preparation and I am pleased to share the following guest blog that discusses the advantages and addresses concerns about moving from manual to automated buffer preparation. I was fortunate to be able to interview the author about his article and have provided the transcript of our conversation following the guest blog…

Headlines:

“GenSight Biologics seeks EU approval for gene therapy,” PharmaTimes

French biopharma company Gensight Biologics has submitted a marketing authorisation application for its lead gene therapy Lumevoq to the European Medicines Agency (EMA). Gensight is aiming to win approval for Lumevoq (lenadogene nolparvovec) as a treatment for patients with vision loss due to Leber Hereditary Optic Neuropathy (LHON), caused by mutation in the ND4 mitochondrial gene…

“Lonza works with Humanigen on COVID-19 drug candidate lenzilumab,” Reuters

“Swiss contract drug maker Lonza struck a deal with California-based biopharmaceutical company Humanigen to expand manufacturing capacity for Humanigen’s lenzilumab, a drug candidate in late-stage clinical trials for COVID-19. Lenzilumab is in phase III clinical trials to determine whether the drug can prevent and treat an immune hyper-response in COVID-19 patients called “cytokine storm”, the companies said in a statement on Tuesday…”

“Univercells Introduces NevoLine Upstream Platform,” Contract Pharma

“Univercells Technologies has introduced a new platform in the NevoLine biomanufacturing product family—the NevoLine Upstream platform. This high-performance, low-footprint upstream manufacturing platform is suitable for multiple viral applications to support the booming gene therapy market and offer a cost-effective tool for rapid response to emerging infectious diseases…”

“Moderna Shares the Blueprint for Its Coronavirus Vaccine Trial,” The New York Times

“The biotech company Moderna released a 135-page document on Thursday that spells out the details of how it is conducting the late-stage trial of its coronavirus vaccine, and how safety and efficacy will be determined. The document suggests that the first analysis of the trial data may not be conducted until late December, and that there may not be enough information then to determine whether the vaccine works. Subsequent analyses, scheduled for March and May, are more likely to provide an answer…”

“China starts testing nasal spray coronavirus vaccine,” The Hill

“China on Wednesday approved the first phase of human testing for a nasal spray vaccine, the first trial vaccine for the coronavirus that does not require a needle injection. The spray vaccine was co-developed by researchers at Xiamen University and Hong Kong University with the aid of vaccine maker Beijing Wantai Biological Pharmacy Enterprise, Bloomberg reported…”

“NIH chief, surgeon general vow ‘science alone’ will guide vaccine,” UPI

“National Institutes of Health Director Francis Collins and U.S. Surgeon General Jerome Adams on Wednesday told the Senate that approval of a COVID-19 vaccine will be based on science alone. Appearing before the Senate Committee on Health, Education, Labor & Pensions, Collins and Adams each responded to a question by Sen. Bernie Sanders, I-Vt., by stating that political pressure will not play a role in any decision on when or whether to approve a COVID-19 vaccine for use by the public…”