A Three-Decade Monopoly: How Amgen Built a Patent Thicket Around Its Top-Selling Drug
Three decades ago, a scientist at the University of Texas named Bruce Beutler asked the U.S. government to grant him a patent for a new invention. Beutler, who would later win the Nobel Prize for his research, had come up with a way to shut down certain types of inflammation in cells. His discovery became the foundation of the arthritis drug Enbrel, among the highest-selling pharmaceutical products in history and the backbone of one of the industry’s largest companies, Amgen. In 2029, an incredible 37 years after Beutler first sought his patent and 17 years after it expired, Enbrel could finally face lower-cost competition in the U.S. That longevity is due to Amgen’s efforts to build an interlocking wall of intellectual property protection that’s often referred to as a “patent thicket.” Learn More
AstraZeneca to Transfer Some Drug Rights to Covis Pharma in $270 Million Deal
AstraZeneca says it will transfer global rights for respiratory medicines Eklira and Duaklir to Covis Pharma Group for $270 million, as the drugmaker looks to offload its older portfolio of medicines. The company also said that under the deal, which is expected to close in the fourth quarter of 2021, Covis will also cover certain ongoing development costs related to the medicines. AstraZeneca, which has several new medicines in its pharmaceutical pipeline, including COVID-19 drugs and a vaccine, expects the agreement to help sharpen its focus on priority medicines in its respiratory and immunology portfolio. Covis had previously acquired the rights to other respiratory medicines Alvesco, Omnaris and Zetonna from AstraZeneca in 2018. Learn More
Jaguar Gene Therapy to Build $125 Million Manufacturing Facility in North Carolina
Jaguar Gene Therapy will build a new $125 million manufacturing facility just down the street from its lab facility in Cary, North Carolina. The already existing site, encompassing roughly 174,000 square feet, will be converted to the company’s manufacturing specifications and support clinical and commercial manufacturing. The company said the facility will “support future clinical and commercial production of the company’s initial programs, including: galactosemia; a specific genetic cause of autism; and Type 1 diabetes.” Jaguar, a two-year-old company, raised $139 million from investors, including Eli Lilly, earlier this year. Learn More
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On This Day Alert
Today is Day of the Dead, also known as Dia de Los Muertos
Day of the Dead, or Dia de Los Muertos in Spanish, is a holiday that originated thousands of years ago in Mexico. Even though it’s often thought of as interchangeable with Halloween, the two are different holidays, with unique roots and traditions. Day of the Dead is annually observed on November 1 and 2 with the main festivities held on November 2. On these days, it is believed that the gate between the spirit world and real world dissolves, and families welcome the souls of deceased relatives with food, drink and celebrations. Learn More
Martha will be bringing her academic expertise and personal heritage to the stage, speaking about the cultural traditions of the Day of the Dead in Mexico. She will explain what we can learn from a relationship where death is not feared but celebrated. Learn More
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Bioprocess Alert
Comparative Testing of Single Use Pump Technologies Used in Downstream Processing For Watson-Marlow Fluid Technology Group
After comprehensively reviewing the capabilities and performance of the Watson-Marlow Quantum 600 peristaltic pump, it is the position of PDS Sandbox that the data generated during these tests, demonstrates an excellent level of precision across a full range of pressures (up to 4 barg), with low shear that is approximately 50% lower than that of the Quattroflow QF1200SU pump from PSG Dover. The test report also confirms that the Quantum 600 pump has minimal impact on CHO suspension cell cultures. This performance is better than would be expected with traditional peristaltic pumps and is comparable to the Levitronix PuraLev®200SU centrifugal pump but without the limitations of a strong pressure/flow dependency. Learn More
Using CFD Simulations and Statistical Analysis to Correlate Oxygen Mass Transfer Coefficient to Both Geometrical Parameters and Operating Conditions in a Stirred-Tank Bioreactor
Optimization of a bioreactor design can be an especially challenging process. For instance, testing different bioreactor vessel geometries and different impeller and sparger types, locations, and dimensions can lead to an exceedingly large number of configurations and necessary experiments. Computational fluid dynamics (CFD), therefore, has been widely used to model multiphase flow in stirred-tank bioreactors to minimize the number of optimization experiments. In this study, a multiphase CFD model with population balance equations are used to model gas–liquid mixing, as well as gas bubble distribution, in a 50 L single-use bioreactor vessel. Learn More
At this one-day virtual event, experts and key opinion leaders in the areas of upstream processing, downstream processing, and analytics related to viral vectors and the gene therapy journey will share their insights. In addition to lectures, the event will provide a platform to facilitate networking and discussions with other experts in the field, including during meet-the-speaker sessions and coffee breaks. There is also the possibility for participants to register for a 1:1 meeting with a Sartorius expert. Learn More
Detection and Quantitation of Host Cell Proteins in Monoclonal Antibody Drug Products Using Automated Sample Preparation and Data-Independent Acquisition LC-MS/MS
In the present study, a workflow for HCP detection and quantitation using an automated, magnetic bead-based sample preparation, in combination with a data-independent acquisition (DIA) LC-MS analysis was established. Employing the same instrumental setup commonly used for peptide mapping analysis of mAbs allows for its quick and easy implementation into pre-existing workflows, avoiding the need for dedicated instrumentation or personnel. Thereby, quantitation of HCPs over a broad dynamic range was enabled to allow monitoring of problematic HCPs or to track changes upon altered bioprocessing conditions. Learn More
Work can really suck. And for lots of us, burnout has been feeling especially terrible. This week, we dive into how burnout messes with our brains and bodies, and we find out whether working from home is making things worse. Plus: Could the four-day workweek be the key to fixing our jobs? We speak to neuroscientist Professor Wendy Suzuki, economist Professor Nick Bloom, and Dr. Alex Pang. Learn More
Container Surfaces Control Initiation of Cavitation and Resulting Particle Formation in Protein Formulations After Application of Mechanical Shock
Mechanical shock may cause cavitation in vials containing liquid formulations of therapeutic proteins and generate protein aggregates and other particulates. To test whether common formulation components such as protein molecules, air bubbles, or polysorbate 20 (PS20) micelles might nucleate cavitation, a high-speed video camera was used to detect cavitation in vials containing antibody formulations after application of controlled mechanical shock using a shock test. Higher concentrations of subvisible particles were found in formulations where cavitation had occurred. Bubbles trapped on vial surfaces were a primary site for cavitation nucleation; other potential cavitation nuclei were ineffective. Learn More
Growing Number of FDA Enforcement Actions Stem from Inspection Alternatives
Many of the US FDA’s drug good manufacturing practice (GMP) warning letters and import alerts issued in fiscal year 2021 were based on product sampling and reviewing firms’ written responses to record requests, not from traditional onsite inspections. So asserted Francis Godwin, director of Office of Manufacturing Quality (OMQ) in the FDA’s Center for Drug Evaluation and Research (CDER). In FY 2021, the FDA issued 80 warning letters and 43 import alerts related to drugs. Of the total number of warning letters issued, a majority, or 58.8% were based on testing samples, 26.8% were based on onsite inspections, 12.5% followed up on FDA’s reviewing records, and 2.5% resulted from a company’s refusal to provide records in response to a request. Learn More
New Research Casts Doubt on Claims that People Have ‘Rose-Tinted Glasses’
For decades scientists have believed that people have an 'irrational optimism bias' -- they look too much to the bright side and underestimate their chances of negative experiences. while overestimating their chances of positive events. This over-optimistic tendency is taken into account by the UK government when planning large infrastructure projects. However, a new study by researchers at the University of Bath, UCL, and Birkbeck, University of London, demonstrates flaws in research supporting the existence of optimism bias. According to the authors, prior studies have generated 'false positives' -- data patterns that look like people are being over-optimistic, where no such bias exists. Learn More
Project Alert
Bionova Scientific Unveils New Commercial-Ready GMP Biologics Manufacturing Facility
Bionova Scientific, a biologics CDMO has announced the grand opening of its commercial-ready fully single-use GMP biologics manufacturing center at its Fremont, California headquarters. The first clinical supply run at the state-of-the-art facility will be completed before year-end 2021. The facility was designed by DGA Architecture and built by Dome Construction. At launch, the facility will operate one 1000 liter Cytiva XDR upstream train. A 2000 liter Cytiva system will be added in Q3/2022 with a second 2000 liter system to follow as client demand dictates. The facility was engineered to meet global commercial drug manufacturing regulations. Learn More
Anti-VEGF Protein Compositions and Methods for Producing the Same
A U.S. Patent for "Anti-VEGF Protein Compositions and Methods for Producing the Same" was awarded to Regeneron on August 24, 2021. The present invention pertains to compositions comprising aflibercept and methods for producing such compositions in chemically defined media and using chromatography to reduce amounts of certain aflibercept variants. Learn More
In this application note, it will be clarified why the Scottish biotechnology company Ingenza, which operates GMP compliant laboratories for the construction, optimization and application of engineered microbial strains, has decided to move from electrochemical to optical sensors, in order to perform reliable in-situ automated control of DO for microbial cultures such as E. coli, P. putida, Bacillus sp, P. pastoris and S. cerevisiae, in laboratory scale bioreactors. Learn More
More time and effort went into the Pixar movie, Coco, inspired by the Mexican holiday, Day of the Dead than any other Pixar film.
Disney Pixar’s 'Coco' has been credited with helping popularize the Day of the Dead. Photo: Disney Pixar
“Coco” was in production between 2011 and 2017. The film set a Pixar record for being a Pixar animated film with the longest production schedule and spent more days as #1 spot at the box office than any other animated film in the 21st century. Learn More
Saint-Gobain Applications Engineer II Beaverton, MI
In this position, the employee will work with customers in developing innovative Single-Use solutions for Bio/pharmaceutical & Medical applications using Saint-Gobain and other supplied components. Learn More
Sanofi Principal Engineer, Upstream Framingham, MA
The successful candidate will work with a group of scientists and engineers responsible for technology transfer mammalian cell culture processes to a diverse network of manufacturing facilities, Lifecycle Management and support of commercial processes. Learn More
Pfizer Bioprocess Technician (BPT) III Sanford, NC
The candidate will be responsible for operating equipment, completion of support tasks and at times the oversight of assigned activities, in order to obtain the production plan of record. Primary responsibilities will be related to process support (e.g. cleaning, autoclave, washers, buffer, and media preparation). Learn More
GSK Associate Scientist - Downstream Process Development King of Prussia, PA
As an Associate Scientist in Downstream Process Development, you will be a member of a highly skilled team of scientists and engineers responsible for the evaluation and optimization of purification processes. You will be involved in all aspects of the development of purification processes. Learn More
