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:

Scale-Out Biomanufacturing – A Paradigm Change to Scale Up

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…

Ask the Expert – Cancer Research

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…

The Next Level of Quality for Cell Therapy Media – Beyond Xeno-Free

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…

Theranostics: an old approach with new interest

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…

The Top 25 Downstream Column Blogs of 2017

I have compiled a list of our most popular 25 blogs, podcasts, and webinars for 2017 listed in alphabetical order…

Protein A Chromatography – A look at where we have been and where we are going

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…

Resolving large scale buffer management 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?…

Webinars:

The Process Economics of Continuous Downstream Bioprocessing

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.

Podcasts:

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:

Headlines:

“Sanofi, Facing Threat From Generics, Moves to Buy Hemophilia Drug Maker,” The New York Times

“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…”

“Senate votes to confirm Azar as health secretary,” Reuters

“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…”