This week’s headlines include: A liver cell transplant of CRISPR-edited liver cells could replace lifelong injections for hemophilia B patients, U.S. approves Novartis Cell Therapy for lymphoma, FDA clears Pluristem radiation treatment for emergency use, Gilead, Verily Launch Inflammatory Disease Collaboration, and Tick and Mosquito Infections Spreading Rapidly, C.D.C. Finds.

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

Benefits of a defined, blood-free virus production media for vero cells

Vero cells are a very popular cell line choice for virus production in vaccine manufacturing. Reasons for their popularity include a long history of safety and successful proliferation in variety of vessel types including flasks, cell factories, and microcarriers in bioreactors. However vero cells are adherent cells and must be supported in attachment with a robust virus production media to ensure good growth and productivity…

In-house Rapid Mycoplasma Test Qualification Provides a Cost-effective, Quick Turnaround Solution for Cell Therapy Product Release Testing

Rapid microbial methods can detect microbial contamination faster than traditional testing methods. Rapid microbial methods also require lower sample volumes for testing because of increased assay sensitivity. The quicker turnaround time from sampling to results also supports final release testing closer to actual final product release, thus enhancing the product’s safety profile. The quick turnaround time and lower sample volume requirements also permit close to real time in-process testing, thereby enabling process analytics and quality by design initiatives. Quality by design is particularly important considering the high value of these therapies. QbD ensures that all critical quality attributes are met and having in-process information ensures better manufacturing control and decision making during manufacturing…

Risk Mitigation Plan for Biologics Manufacturing using a Quality by Design (QbD) approach

The FDA and the biopharmaceutical industry collaborated to move forward a Quality by Design (QbD) approach to biopharmacuetical manufacturing. QbD was created as a way to ensure that all critical quality attributes for a product are maintained throughout the manufacturing process. This week’s Two Minute Tuesday educational video provides an overview for creating as biosafety risk mitigation plan, an important part of the QbD process. Regulatory bodies have made it clear that testing alone is not a sufficient risk management strategy and this video walks through a risk management approach. For the full video, please see the video below titled, “Biosafety Risk Mitigation Plan Overview“…

Optimizing Virus Production Media for Cell-based Vaccine manufacturing

There has been increasing interest in moving from egg-based vaccine manufacturing to cell culture-based methods. Cell-based vaccine manufacturing is quicker, efficiently scalable and offers more control over the manufacturing environment. There is also the advantage of fewer virus mutations and thus a more effective vaccine. This was certainly true with the 2017-2018 flu season. In a recent PBS article, “Flu vaccine grown without eggs provided measurably better protection this season, FDA says,” the FDA reported that the approved cell-culture based influenza vaccine performed about 20 percent better than the standard egg-based vaccines. This is due to the fact that the viruses have to adapt to grow in the eggs and with this adaptation can come mutations that render the vaccine less effective…

Video – Viral Safety in Biologics Manufacturing

Regulatory bodies have long recognized that viral safety in biologics manufacturing is a top priority. The presence of adventitious agents such as bacteria, mycoplasma, adventitious viruses, endogenous retroviruses, fungi/molds and prions represent a significant threat with patient safety, medicine shortages, costly decontamination as the key concerns. While viral contamination is rare it has happened. To help prevent contamination regulatory guidelines have been established to evaluate viral safety in biologics manufacturing. These guidelines evaluate potential risk and establish testing requirements for the entire biomanufacturing process. This week’s Two Minute Tuesday educational video provides an introduction to viral safety and looks at areas of risk, the regulatory guidelines, testing requirements and critical steps in the biologics manufacturing process. For the full video, please see the video below titled, “Introduction to Viral Safety“…

Intensify process development steps and simplify transfer to GMP environment with new ÄKTA pilot 600 chromatography system

The bioprocess industry is leaving the blockbuster era. The strive to shorten time to market is constant, which puts pressure on the entire drug development process from research to manufacturing. With more drugs in pipeline, biomanufacturers need flexibility, efficient changeovers, and accelerated scale-up and transfer to the next development phase…

Cell Harvesting – Selecting a technology compatible with cell density and feed turbidity

In this podcast and accompanying article, we interviewed Silke Bergheim-Pietza, Global Product Manager Depth Filtration, Pall. We discussed challenges faced in the cell harvesting step, in particular, selecting the best cell harvesting method based on the cell density and feed turbidity of the process and meeting the demand of increasing cell densities. Download the cell harvesting technology selection guide and use the guide to compare the latest single-use harvesting technologies...

Flexible Downstream Platform Facilitates Adaptation to Scale

In biomanufacturing, upstream titers are increasing as new cell lines and technologies are being developed. This puts pressure on downstream processes, especially the capture step…

Professional Training:

Continuous Downstream Processing Training Course

The BioFactory Competence Center (BCC) in Fribourg, Switzerland has partnered with Pall Biotech to offer a continuous downstream processing training course from 3rd – 5th July 2018.  Attendees will learn about the different technologies available for continuous processing steps including cell separation, filtration and chromatography.  The three day course is focussed on practical hands-on work in the laboratory with small class sizes.  Further information can be found at http://www.bcc.ch/continuous-downstream-processing.html.

Opened in 2016, the BCC is a non-profit educational facility dedicated to advancing the biopharmaceutical industry through educational sessions and real-time support. Pall Biotech is a leading manufacturer of continuous bioprocessing equipment.

Podcasts:

Check out our podcast channel. We have over 20 great podcasts covering drug discovery, stem cell culture, upstream and downstream biomanufacturing and more! Click below to download from iTunes or Google play:

Headlines:

“A Salk Institute team transplanted liver cells into mouse models of hemophilia B, finding that the treatment restored their ability to form blood clots for a year. The hope is that this one-and-done treatment could replace the frequent injections of clotting factors that are currently used to treat the inherited blood disorder…”

“U.S. regulators approved Novartis’ Cell Therapy Kymriah for treatment of patients with a second type of blood cancer, large B-cell lymphoma, that has worsened despite two or more earlier lines of therapy, the Swiss drugmaker said on Tuesday…”

“FDA clears Pluristem radiation treatment for emergency use,” Reuters

“Pluristem Therapeutics Inc, a developer of placenta-based stem cell products, said the U.S. Food and Drug Administration has cleared the emergency use of its therapy to treat acute radiation exposure in a nuclear event…”

“Gilead, Verily Launch Inflammatory Disease Collaboration,” Genetic Engineering News

“Gilead Sciences will partner with Google parent Alphabet’s Verily Life Sciences over the next three years to study immunological and molecular drivers of three inflammatory diseases, the companies said. The value of the collaboration was not announced, though Forbes reported that Gilead had agreed to pay Verily up to $90 million over the three-year period…”

“Tick and Mosquito Infections Spreading Rapidly, C.D.C. Finds,” The New York Times

“The number of people getting diseases transmitted by mosquito, tick and flea bites has more than tripled in the United States in recent years, federal health officials reported on Tuesday. Since 2004, at least nine such diseases have been discovered or newly introduced here. The Centers for Disease Control and Prevention did not suggest that Americans drop plans for softball games or hammock snoozes. But officials emphasized that it’s increasingly important for everyone — especially children — to be protected from outdoor pests with bug repellent.”…