A consortium of drug companies called the COVID R&D Alliance have announced that they have enrolled the first patients in an unusual "platform trial" that will test three different drugs in patients hospitalized with coronavirus disease. The study, known as the I-SPY COVID Trial, is evaluating whether Amgen's Otezla, Takeda's Firazyr and AbbVie's experimental drug cenicriviroc can combat the life-threatening immune overreactions some COVID-19 patients experience. The alliance, which includes Amgen, Takeda, AbbVie and 18 other drugmakers, said the I-SPY drugs were selected based on how they affect the immune system. Learn More
Sanofi Formally Investigated Over Epilepsy Drug Depakine
Sanofi has been placed under formal investigation on charges of manslaughter over Depakine, which is an epilepsy drug that caused birth malfunctions and slow neurological development when taken during pregnancy. In France, being put under formal investigation means that a dedicated investigative judge considers the case is serious enough to warrant an investigation. For its part, Sanofi denies the charges and is challenging the merits of the investigation, it said in a written statement to Reuters. Depakine, which lost its patent in 1998, is prescribed in more than 100 countries. Learn More
FDA Purple Book Database Now Includes All CBER, CDER Licensed Biological Products
The US FDA, in updating the Purple Book, its database of FDA-licensed biologic products, will also include exclusivity information for biological products as well as a glossary. Biosimilar and interchangeable biological products are included in the searchable online database. The current list of products maintained by CBER will not be further updated by the FDA. The Purple Book Database now contains biosimilar and interchangeable biological products and allergenic, cell and gene therapy, hematologic, and vaccine products. Transition biologic products that were originally approved via New Drug Applications (NDAs) but transitioned to Biologic License Applications (BLAs) also appear in the database. Learn More
FDA Purple Book Database Now Includes All CBER, CDER Licensed Biological Products
The US FDA, in updating the Purple Book, its database of FDA-licensed biologic products, will also include exclusivity information for biological products as well as a glossary. Biosimilar and interchangeable biological products are included in the searchable online database. The current list of products maintained by CBER will not be further updated by the FDA. The Purple Book Database now contains biosimilar and interchangeable biological products and allergenic, cell and gene therapy, hematologic, and vaccine products. Transition biologic products that were originally approved via New Drug Applications (NDAs) but transitioned to Biologic License Applications (BLAs) also appear in the database. Learn More
Measurement Challenges with Optical Dissolved Oxygen Sensors
Measurement of dissolved oxygen (DO) has long been known as a critical control parameter for optimizing cell growth in bioprocesses. Much has been written about different strategies for proper DO control. However, little information has been publicly available regarding optimization of the actual measurement accuracy and reducing common sources of process-related error. This paper aims to divulge these details for the first time. Specific consideration will be given to optical dissolved oxygen measurement which has become the predominant measurement technology in bioprocesses. Learn More
Can you recommend a dedicated benchtop instrument for measuring Osmo (osmolality)?
Based on my experience, if you are looking for a benchtop instrument dedicated to the accurate and reliable measurement of Osmo then your best bet is the benchtop solution from Advanced Instruments. They are arguably the gold standard for osmolality measurement in our industry. Having enabled some of the most well-known stand alone and integrated bioprocessing solutions. Here is a link to more information;
Cell Density and Viability Comparability Studies
Cell density and viability are critical process parameters in many cell culture applications for biologics development and production. Monitoring the health and growth of the culture is so important that numerous methods have been developed to meet this need. Automated cell counting has become the gold standard in many applications due to its consistency, accuracy, and ease of use. Additionally, by trypan blue dye exclusion method some systems integrate directly with bioreactors or microbioreactor systems to provide on-line measurement, streamlining workflow. Learn More
Webinar: Filtration Fundamentals – Clarification & Sterilization for the Manufacture of Recombinant Proteins, Part II
Thursday, August 6th, 2020
Presenter: Ethan Lovdal Butler, PhD
In this the second part of Ethan's two-part webinar series on the fundamentals of filtration, he marries a rigorous theoretical treatment of mass transport phenomena with practical application to clarification and sterilization processes used at biopharmaceutical companies every day. Based on his lectures at the Massachusetts Institute of Technology, Ethan starts with a broad overview of filtration terminology and then delves deeply into structure-function relationships, phenomenological modelling, bench-scale analysis and process-scale sizing. These webinars are intended for new and experienced process development scientists alike and will set the foundation for advanced topics discussed in later webinars.
Virologists Identify Potential COVID-19 Treatment
Virologists in the College of Veterinary Medicine at Kansas State University have published a study showing a possible therapeutic treatment for COVID-19. The study, "3C-like protease inhibitors block coronavirus replication in vitro and improve survival in MERS-CoV-infected mice," appears in this week's issue of the medical journal Science Translational Medicine. It reveals how small molecule protease inhibitors show potency against human coronaviruses. These coronavirus 3C-like proteases, known as 3CLpro, are strong therapeutic targets because they play vital roles in coronavirus replication. Learn More
Method for Producing a Product (e.g. polypeptide) in a Continuous Cell Culture Fermentation Process
A U.S. Patent for "Method for Producing a Product (e.g. polypeptide) in a Continuous Cell Culture Fermentation Process" was awarded to CMC Biologics on July 21st, 2020. The present invention is a method for producing a product selected from a biopolymer expressed by a cell or microorganism, an intracellular or extracellular product produced by a cell or microorganism, a periplasmatic product produced by a cell or microorganism, in a first and a second bioreactor in a chemostat fermentation process, wherein said first bioreactor comprises: i) optionally a first outlet having a separation device allowing impurities with a size below the size of the product... Learn More
1936 Jesse Owens Wins Long Jump and Respect in Germany
On this day in 1936, American Jesse Owens wins gold in the long jump at the Summer Olympics in Berlin, Germany. It was the second of four gold medals Owens won in Berlin. Learn More
Is ‘Cancel Culture’ a problem?
The Secret Weapon That Let Dinosaurs Take Over the Planet
We've all heard the theories on why the dinosaurs died -- but how did they come to dominate the earth for so long in the first place? (Hint: it has nothing to do with their size, speed, spikes or fantastic feathers.) Travel back in time to 200 million years before their extinction with paleontologist Emma Schachner for a breath of fresh air on dinosaur history. Learn More
Wacker to Upgrade Production of Biologics and Vaccines at Amsterdam Site
Wacker is investing in its production facilities for biologics, LMPs (live microbial products) and vaccines at its Amsterdam site. Projects include the construction of a new fermentation line with a volume of 1,500 liters as well as the setting up of new cleanroom structures in the 270-liter fermentation line. According to the company, the investment price is a mid-double-digit million-euro amount. Among other improvements, new utility supplies are planned, such as water for injection. These measures will contribute to preparing the plant to produce new classes of actives, such as pDNA and mRNA-based vaccines. Learn More
Viggo Mortensen Purchased the Horse He Rode in the Lord of the Rings Movie
The horse had a hard time adjusting to the lights and sounds on set and it took a while for them to get in sync but they developed a strong bond in the end. He would also purchase two more of his equine co-stars, including his horse from Hidalgo. Learn More