This week’s headlines include: Researchers Explore a Cancer Paradox, 3D human neural network could aid studies in brain diseases, Grandma Was Right: Sunshine Helps Kill Germs Indoors, Amgen begins rolling out Humira biosimilar in the EU, and The Biotech Innovation That Will Transform Society Has Arrived (Hint: It’s Not CRISPR).

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CELL SERIES

The annual Cell Series features 4 outstanding programmes: our long-running 7^th Cell Culture and Bioprocessing, 5^thStem Cell & Regenerative Medicine, 4th Cell and Gene Therapy and Biobanking Congresses. The Cell Series provides a focused networking platform targeting Cell Culture & Cell Line Development and Bioprocessing; Cell & Gene Therapy highlighting CAR T Cell Development; Stem Cell & Regeneration Medicine Development as well as Biobanking.

In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:

Viral Vector Characterization: A Look at Analytical Tools

As cell and gene therapy field continues to push products through the clinical landscape, the need to develop appropriate analytical tools has become increasingly evident. Because of their intended use in patients, gene therapy products must meet rigorous safety guidelines highlighting the importance of well-characterized analytics…

Isolation of Mononuclear and Polymorphonuclear Leukocytes from Blood with Density Separation Media

Blood is a specialized body fluid composed of four main components: plasma, white blood cells (leukocytes), red blood cells (erythrocytes), and platelets (thrombocytes). Unlike red blood cells and platelets, all white blood cells are nucleated and can be classified by their nuclei structure as mononuclear or polymorphonuclear cells…

Biotech Week Boston 2018: Cell and Gene Therapy Bioprocessing and Commercialization Highlights

Biotech Week Boston, held at the Hynes Convention Center in Boston, MA, was a fantastic amalgamation of scientific conferences, training courses, and keynotes all focused on cell bioprocessing. The theme of this year’s Cell and Gene Therapy Bioprocessing and Commercialization conference was “transforming innovative research to drive the future of cell & gene therapy by relieving bottlenecks and pain points in clinical development, manufacture and commercialization of cell, gene and immunotherapies”…

Overview of the Regulatory Path to Commercializing a Gene Therapy

After decades of research, gene therapies now comprise much of the R&D and manufacturing pipelines in the United States and around the world. Huge strides in biological understanding and the development of key enabling technologies are at long last delivering on the promises of precision and personalized medicines. While there is still much more to learn and develop, regulatory constructs keeping pace with the speed of innovation remains a sizeable challenge…

A Defined Synthetic Growth Surface for Stable hiPSC Expansion

hiPSCs cultivation can be challenging with lot-to-lot coating variations, tedious preparation and increased contamination risk. In particular, biological coatings may negatively impact downstream applications due to the presence of undefined extracellular matrix (ECM) components and growth factors. Another common struggle is decreased reproducibility of data due to an inherently complex and non-defined growth surface. To address these common challenges, Eppendorf has introduced a ready-to-use consumable with synthetic fibronectin-derived motifs to support stem cell attachment by mimicking the native ECM protein fibronectin. The FN1 motifs surface allows expansion of stem cells in various xeno-free media and other restrictive culture conditions. Thus, you can establish a completely defined culture system for your stem cell culture without any animal or human components…

A Guide for Selecting the Correct Filter Integrity Test Instrument

Selecting the right filter integrity test instrument is an important task. An informed, balanced choice will support the seamless integration of the instrument into critical processes and provide trouble-free operation for years to come. The right choice may be made more difficult by different departments, or user groups, who may assign a different value to the same feature. A rational approach is beneficial to ensure the selected instrument can fulfill all the selection criteria for all interested parties, with any compromises being limited to non-critical characteristics…

Downstream Manufacturing of Gene Therapy Vectors

The goal of downstream processing is to separate the viral vector from the various impurities produced during upstream processing and to get the virus into the appropriate state for formulation and administration to patients. Viral vector batches destined for clinical use must comply to increasing regulatory standards for impurities and contaminants as these can affect product safety and potency. In addition to providing purity, purification processes need to meet production scale, which can be quite large for clinical trials and commercial applications…

How Robots Are Changing The Landscape Of The Medical Field

Robotics are becoming increasingly present in many different industries. In the medical world, robots and AI are helping medical professionals conduct procedures, understand the risk of surgical complications, and provide more precise patient care….

Continuous biomanufacturing – Key drivers for adoption, economic modelling and regulatory considerations

The Medicine Maker recently published a multi-authored eBook on Continuous Biomanufacturing, titled, “The Continuous Way”. The publication includes seven articles covering the topic of continuous biomanufacturing from a variety of angles. I really enjoyed the eBook and it provided a great update on the current state of continuous biomanufacturing as well as information about key drivers for adoption, new economic modeling, and integration of continuous operations. Following is a sampling of articles with key highlights…

Cool Tool – Inline Diafiltration Closes the Gap for End-to-End Continuous Bioprocessing

Diafiltration, while fulfilling several functions in protein purification, has also presented a major obstacle in achieving continuous biomanufacturing. Technologies launched over the last decade have moved the industry closer to completing an integrated end-to-end continuous bioprocessing platform; however adequately addressing continuous final ultrafiltration/diafiltration of drug substance has been challenging. Now, inline diafiltration offers a solution to both traditional bottleneck hurdles and continuous biomanufacturing platform gaps…

Headlines:

“Researchers Explore a Cancer Paradox,” The New York Times

“Cancer is a disease of mutations. Tumor cells are riddled with genetic mutations not found in healthy cells. Scientists estimate that it takes five to 10 key mutations for a healthy cell to become cancerous. Some of these mutations can be caused by assaults from the environment, such as ultraviolet rays and cigarette smoke. Others arise from harmful molecules produced by the cells themselves. In recent years, researchers have begun taking a closer look at these mutations, to try to understand how they arise in healthy cells, and what causes these cells to later erupt into full-blown cancer…”

“Scientists have built all kinds of human tissue models to help them understand disease progression, optimize drug discovery, and even to regenerate diseased organs. A Tufts University-led team has now developed 3D models of the central nervous system that could aid future research into neurodegenerative diseases like Alzheimer’s…”

“Grandma Was Right: Sunshine Helps Kill Germs Indoors,” NPR

“Even before Florence Nightingale advised that hospitals be designed to let daylight in, people observed that sunshine helps keep you healthy. But there was not much research to explain why that’s the case, especially inside buildings. Researchers at the University of Oregon set up a study of dusty, dollhouse-size rooms to compare what happens in rooms exposed to daylight through regular glass, rooms exposed to only ultraviolet light and those kept dark. They used a mix of dust collected from actual homes in the Portland area and let the miniature rooms sit outdoors while keeping the insides at a normal room temperature…”

“Amgen has begun launching Amgevita, the first biosimilar of AbbVie’s anti-inflammatory blockbuster Humira to win approval in Europe, across the region…”

“The Biotech Innovation That Will Transform Society Has Arrived (Hint: It’s Not CRISPR),” Forbes

“I was in line for coffee at the Business Innovation Factory (BIF) Summit this past September and was starting to get jittery. I began making conversation with the guy in front of me to distract myself, and since java was on my mind I figured that was as good a topic as any. So I made a throwaway comment about how useless I was until I got my morning cup…”