This week’s headlines include: Sanofi, Facing Threat From Generics, Moves to Buy Hemophilia Drug Maker, Senate votes to confirm Azar as health secretary, KBI Biopharma acquires assets of Louisville-based Elion, Biogen’s MS drug Tecfidera could make cancer-killing viruses more potent: Study, Toward a Universal Flu Vaccine, and New clues to T cell development could boost search for HIV vaccine.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
In biomanufacturing, a production scale change is required to either meet the market growth demand or when a product moves from clinical to commercial manufacturing. How that volume is increased depends on whether a scale up or scale out philosophy is used. The industry standard has been to scale up, which translates to increasing the size of the bioreactors used in manufacturing runs. However, due to the recent availability and ease of single-use technologies, coupled with improvements in cell culture productivity; scale out may soon create a shift in the way biologics are manufactured…
Unlocking the complexities of cancer is an ongoing challenge. Luckily, a countless number of researchers are working every day – determined to understand the causes and behaviors of cancer in search of new and better ways to more effectively treat the disease…
Since the advent of in vitro biology, mammalian cell culture and cell culture-based assays have served as an indispensable tool in the elucidation of biological processes. This article will discuss the current landscape of FBS and human serum use and their limitations, as well as introduce a powerful alternative…
Precision medicine has been a growing trend in healthcare for years. Doctors and researchers are leveraging computer power, modern analytics, cloud technology and patient information from genomics to demographics to help make more individualized and accurate treatment plans. What if there were a more direct link between a diagnostic test and the potential therapies available for a patient? Well that is the aim of theranostics, a field of personalized and precision medicine that links targeted therapies to specific diagnostic tests. Theranostics represents one approach for transitioning from conventional medicine to a more contemporary patient-specific analysis and therapy (1). While having evolved into a number of particular approaches, a theme currently in vogue is the use of either micro- or nano-particles in a marriage of diagnostic imaging and therapeutic activities. This results in the use of a single nano-particle agent to be employed in screening, diagnosis and treatment delivery as well as in prognosis or response monitoring…
I have compiled a list of our most popular 25 blogs, podcasts, and webinars for 2017 listed in alphabetical order…
In this podcast and accompanying article, we interviewed Jonathan Royce, Business Leader, Chromatography Resins, GE Healthcare Life Sciences, about the evolution of Protein A including the latest developments in Protein A chromatography resins. We also discussed what the future holds for this purification mainstay and how it can continue to address the changing needs of biopharma…
Downstream Bioprocessing Cost Modeling – Looking at Integrated Continuous, Single-use and Stainless Steel Platforms
Process economics are frequently discussed with respect to continuous biomanufacturing implementation. More specifically, are the potential cost benefits worth making a manufacturing change and in which situations are the benefits greatest? At Biotech Week Boston in September, there was a very interesting talk titled “Cost modeling of the downstream bioprocessing design space,” presented by Mark Schofield, Ph.D., Senior R&D Manager, Pall Life Sciences. In the talk, Dr. Schofield shows data related to cost modeling the downstream bioprocess design space. He also describes some of the challenges facing biomanufacturing including cost pressure, competition, and the rise of biosimilars, and how implementing integrated continuous operations can address several of these challenges…
In this podcast and accompanying article, we interviewed Joakim Lundvist, Modality Manager, BioProcess™ Hardware, GE Healthcare about large-scale buffer management challenges. Buffer preparation is known to be one of the most resource-intensive activities in biomanufacturing as large volumes of buffers and process liquids are often required. So how can this be done in a more efficient way? How can more capacity be added to buffer preparation without adding major capital investment? Are there ways to reduce the manufacturing footprint and time spent on buffers?…
New Webinar Available On Demand!
The cost of goods of an Integrated Continuous Bioprocessing (ICB) platform for the manufacturing of a mAb from fed-batch cell harvest has been evaluated using BioSolve Process, a modeling software from BioPharm Services. The costs associated with the ICB platform were compared to those of stainless steel and single-use batch processes. These downstream processes were evaluated across sets of clinical and commercial production scenarios. For both sets of scenarios, 27 different cases were modeled by varying 3 factors: bioreactor titer, volume, and number of batches per year. By taking this approach, the cost-benefits of the ICB platform could be seen across a wide range of manufacturing scales.
In this webinar, participants will learn:
- The findings of the full-factorial modeling exercise.
- The cost-benefits of continuous bioprocessing at many scales of manufacturing.
Check out our podcast channel. We have 15 great podcasts covering drug discovery, stem cell culture, upstream and downstream biomanufacturing and more!
Click below to download through iTunes or Google play:
“The French drug maker Sanofi said on Monday that it had agreed to acquire Bioverativ, a biopharmaceutical company focused on treatments for hemophilia and other rare blood disorders, for $11.6 billion in cash…”
“The U.S. Senate on Wednesday voted to confirm former pharmaceutical industry executive and lobbyist Alex Azar as the next Health and Human Services secretary…”
“KBI Biopharma Inc. purchased the assets of Elion, a contract services organization serving the biopharmaceutical industry. Elion’s services include analytical method development, qualification and validation, characterization of biologics, and comprehensive data analysis, including visualization and interpretation of complex data sets…”
“Cancer-killing viruses, also called “oncolytic” viruses, made their entry into oncology practices in 2015 with the approval of Amgen’s melanoma drug Imlygic, which was derived from herpes. Many other companies are studying a range of viruses as potential cancer remedies—but finding limited success so far…”
“Researchers have inched closer to a universal flu vaccine, using a genetically modified live virus to safely protect a small number of mice and ferrets against influenza. The flu can make people sick despite repeated vaccinations—in part because the strain(s) selected for the vaccine may not be matched well to the strain that is circulating that year—but also because the virus has a mechanism for evading the body’s immune system. A new universal flu vaccine candidate, developed by scientists from the University of California Los Angeles and elsewhere, gets around this viral mechanism…”
“Scientists around the world have spent many years trying to make effective vaccines for HIV and hepatitis C, with little success. So the only way to control these chronic viruses is with drugs. Antiretroviral medicines effectively control HIV levels, but the slightest slip in adherence could send virus levels bouncing back. And while a number of new hep C drugs have hit the market in recent years, they tend to be pricey, with Gilead’s Sovaldi going for $1,000 per pill, or $84,000 for a 12-week course of treatment…”