This week’s headlines include: Bill Gates to Help Fund Coronavirus-Vaccine Development, WHO says coronavirus vaccine and treatment research has ‘accelerated at incredible speed’, Here Are All the Companies Working on COVID-19 Vaccines, Treatments, and Testing, FDA Drug Review Times Reflective of 4 Key Features, GAO Finds, Trump speaks with pharmaceutical, biotech CEOs about coronavirus therapies – spokeswoman, Phase 2 of coronavirus vaccine human trials may begin in spring, Moderna chairman says, and Gilead ramps up production of experimental Covid-19 treatment amid criticism over access.

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:

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…

Top 25 Cell Culture Dish Articles of 2019

Don’t miss our top articles of 2019! I have compiled a list of our most popular 25 articles for 2019 in alphabetical order…

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:

“Bill Gates to Help Fund Coronavirus-Vaccine Development,” The Wall Street Journal

“Microsoft Corp. co-founder Bill Gates said his foundation will make billions of dollars available for manufacturing the most promising vaccines to combat the novel coronavirus. Mr. Gates, a billionaire philanthropist who is one the richest people in the world, said the…”

“WHO says coronavirus vaccine and treatment research has ‘accelerated at incredible speed’,” CNBC

“Research to develop vaccines and treatments to fight the coronavirus has “accelerated at incredible speed,” World Health Organization Director-General Dr. Tedros Adhanom Ghebreyesus said Monday. He said more than 70 countries have joined WHO’s trial to accelerate research on effective treatments and “about 20 institutions and companies are racing to develop a vaccine.”

“Here Are All the Companies Working on COVID-19 Vaccines, Treatments, and Testing,” The Motley Fool

“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…”

“FDA Drug Review Times Reflective of 4 Key Features, GAO Finds,” Regulatory Focus

“The length of review of new drug applications (NDAs) by the US Food and Drug Administration’s (FDA) divisions is generally contingent on four features of the application, according to the Government Accountability Office’s (GAO) analysis of 637 original NDAs submitted from fiscal years 2014 through 2018…”

“Trump speaks with pharmaceutical, biotech CEOs about coronavirus therapies – spokeswoman,” Reuters

“President Donald Trump on Monday spoke with the heads of pharmaceutical and biotechnology companies to discuss developments in therapeutics to fight coronavirus, according to White House Press Secretary Stephanie Grisham…”

“Phase 2 of coronavirus vaccine human trials may begin in spring, Moderna chairman says,” CNBC

“The first human trial of a vaccine to prevent the coronavirus could advance to the next step this spring, Moderna Chairman Noubar Afeyan said Thursday.  “It’s difficult to put a specific date on things just because it’s a very dynamic situation,” Afeyan told CNBC’s Meg Tirrell. “We’ve entered phase 1 trials. … We’ll enter hopefully phase 2 trials, we expect that to happen in the spring, perhaps early summer.”

“Gilead ramps up production of experimental Covid-19 treatment amid criticism over access,” STAT

“In response to intensifying demand, Gilead Sciences (GILD) has been ramping up production of its experimental remdesivir treatment that is being tested to combat the novel coronavirus. The drug maker now has 1.5 million individual dosages that could be used for more than 140,000 patients and is supplying the medicine, which is being made available through clinical trials and special access programs, at no charge…”