This week’s headlines include: New data on Gilead’s remdesivir, released by accident, show no benefit for coronavirus patients. Company still sees reason for hope, COVID-19 vaccine tracker, Early treatment with Novartis’ Mayzent stalls secondary progressive MS: study, Grifols says anti-coronavirus hyperimmune immunoglobins may be ready mid-July, Cerevance Raises $45M to Advance Brain Disease Research & Development, Scientists explore using CAR-T and other engineered immune cells to target COVID-19, and SARS-CoV-2 Likely Uses Two Nose Cell Types for Entry.

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:

Webinars:

Preservation of Cellular Therapies 

May 18-19, 2020 – Minneapolis, MN

The course is offered for both in class attendance and over the web for those who cannot attend in person.

Intended audience

The course is designed for a wide range of participants.  The preservation of cells has applications in the fields of recombinant cell biotechnology, cell banking, cell therapy, regenerative medicine, and cell-based assays, for example.  Previous attendees have ranged from manufacturing engineers, laboratory managers, technicians, nurses, and scientists, and several companies have used the course as standard training for their employees.  The course material is designed for those who have little experience with preservation, as well as those proficient in preservation who is interested in improving their practices.

Lecture topics:

• Fundamentals of cryopreservation including mechanism of damage and strategies to prevent damaging cells during freezing, storage and warming,
• Step-by-step protocol development including methods by which to construct a new preservation protocol and debugging an old protocol that is no longer working well,
• Equipment, reagents and supplies used in preservation,
• The challenges in implementing preservation in a clinical/GMP environment,
• Fundamentals of quality control (QC) and quality assurance (QA) as well as application of the program to preservation,
• Design and operation of a storage facility for cryopreserved cells,
• Regulatory issues associated with preservation of a therapeutic product,
• Emerging technology and approaches for the preservation of cells.

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

Cool Tool – The Rebel Analyzer Enables Real-Time Comprehensive Media Analysis in a Benchtop Package

Spent media analysis is a critical part of biotherapeutic process development. The ability to analyze how cell culture components are consumed provides data that speaks to the health and productivity of the culture itself. The data generated allows multiple groups within process development to work together to ensure the best overall process; this includes cell line development, media formulation, process optimization, and purification…

Mesenchymal Stromal Cell Culture – Challenges and solutions for isolation, expansion and maintenance

In this podcast and accompanying article, we talked with Dr. Jennifer Chain, Scientific Director of Research and Development, Oklahoma Blood Institute about isolation of mesenchymal stromal cells from cadaveric bone marrow and the differences between live and cadaveric donors. We also discussed the expansion and maintenance of mesenchymal stromal cells in culture including media design and selection…

Cell Line Development – A look at the evolution, new advances and future developments of this critical process step

In this written interview, Dr Ian Taylor, Chief Business Officer, Solentim, discusses the evolution of cell line development, new advances in technologies and workflows, and future advances. Our discussion includes improved imaging techniques, manual limiting dilution versus single cell seeding, and achieving clonal outgrowth…

Cool Tool – Real-Time Protein Titer Measurement Provides Fast, Simple Solution for Process Development and Production

Protein titer data is a critical during process development and manufacturing of protein-based biopharmaceuticals. Speed and accuracy of this data is key in instituting a process analytical technology (PAT) approach, as this allows for monitoring critical process parameters (CPP) and informs real-time decision making. In addition, this type of data when collected during process development enables optimization of cell culture conditions, protein yield, bioreactor run length and harvest time. Collecting this data during a bioreactor run is ideal, but can be time consuming and resource intensive with traditional tools…

Rapid Mycoplasma Testing for Biologics – Frequently Asked Questions

Cell and gene therapies are poised to revolutionize healthcare, however manufacturing of these products poses new challenges for quality and safety assurance strategies. This is especially true in testing for mycoplasmas, an ubiquitous and practically invisible bacterial contamination of cell cultures. These challenges were a common thread in presentations at the 2019 PharmaLab Pre-Conference Workshop on Mycoplasma qPCR Testing, especially given the anticipated revision of European Pharmacopoeia chapter 2.6.7. Consensus points included, the importance of using cellular matrices for testing and the potential of an implementation strategy that positions NAT as a fast first line of detection, followed by results verification via culture-based compendial methods…

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…

Viral Filtration Validation Study Design – A Systematic Method for Choosing the Most Appropriate Test Approach

Viral filter validation is important to ensure the removal of viruses under the conditions seen at process scale when using scale-down models. When designing an effective study, there are key components that must be decided on. First, it is important to select a virus spike level that will allow for quantification of virus removal, without having a negative impact on the scaled down process. Second, it is important to understand how a virus prefilter will be incorporated into the study design…

Novel affinity resins enabling the purification of next generation antibody fragments: KANEKA KanCap™ G and KanCap™ L

Ever since the licensing of first monoclonal antibody (mAb) drug, biologics have seen unprecedented growth as drugs to treat a variety of malignancies¹. The modular structure of mAbs have allowed protein engineers to create smaller, nimbler, and multispecific next-generation antibody therapeutics. Some of these modalities can be easily produced using microbial expression systems, offering higher yields and excellent process economy²…

Headlines:

“New data on Gilead’s remdesivir, released by accident, show no benefit for coronavirus patients. Company still sees reason for hope,” STAT

“The antiviral medicine remdesivir from Gilead Sciences failed to speed the improvement of patients with Covid-19 or prevent them from dying, according to results from a long-awaited clinical trial conducted in China. Gilead, however, said the data suggest a “potential benefit…”

“COVID-19 vaccine tracker,” Regulatory Focus

“Experts estimate it could take between 12-18 months to develop a vaccine ready for market, which assumes the process from conception to market availability goes smoothly. This tracker lists the major vaccine candidates in development for prevention of COVID-19. This tracker will be updated weekly…”

“Early treatment with Novartis’ Mayzent stalls secondary progressive MS: study,” Fierce Pharma

“In the midst of a societal upheaval resulting from the novel coronavirus and the disease that it causes, COVID-19, there are many efforts in progress to find solutions to slow the spread of the disease and treat those who already have it. These efforts include those from governments, nonprofit organizations, and companies both privately held and publicly traded…”

“Grifols says anti-coronavirus hyperimmune immunoglobins may be ready mid-July,” Reuters

“Spanish pharmaceutical company Grifols said on Tuesday the hyperimmune immunoglobins it is developing as a treatment against SARS-COV-2 could be ready in mid-July. The Barcelona-based company also said it is producing a test device to detect the coronavirus, which it expects to be ready in early May as its plasma centres and industrial and commercial sites remain operational amid the global health crisis…”

“Cerevance Raises $45M to Advance Brain Disease Research & Development,” Xconomy

“Cerevance, a biotech focused on developing new treatments for brain diseases, has added $45 million to its coffers in a Series B financing round from investors including the venture capital arm of Google parent company Alphabet and billionaire philanthropist Bill Gates…”

“Scientists explore using CAR-T and other engineered immune cells to target COVID-19,” FierceBiotech

“CAR-T and TCR-T therapies that involve engineering a patient’s own immune cells with antigen-specific receptors have revolutionized blood cancer treatment. Now scientists at Duke-NUS Medical School are exploring the possibility of turning the approach against COVID-19. The idea of using CAR/TCR-T cell therapy has already been proposed for treating chronic viral infections such as HIV and hepatitis B. Based on previous research, Antonio Bertoletti from Duke-NUS’ emerging infectious diseases research program suggest these immunotherapies might also be useful in treating SARS-CoV-2, the virus causing the current pandemic…”

“SARS-CoV-2 Likely Uses Two Nose Cell Types for Entry,” Genetic Engineering News

“Scientists are racing to understand exactly how SARS-CoV-2 spreads, to help prevent transmission and develop a vaccine. While it is known that SARS-CoV-2 uses a similar mechanism to infect human cells as SARS-CoV—the cause of the 2003 SARS epidemic—the exact cell types involved in the nose had not previously been pinpointed. Now, a collaborative group of researchers from the Wellcome Sanger Institute, University Medical Centre Groningen, and the University Cote d’Azur and CNRS, Nice, have identified two specific cell types in the nose as the likely entry points for the virus…”