This week’s headlines include: Japan’s Takeda clinches $62 billion Shire deal as pharma M&A rolls on, F.D.A. Moves to Stop Rogue Clinics From Using Unapproved Stem Cell Therapies, Using machine learning to see inside live human cells, AstraZeneca, SWIBCo Launch Stem Cell Cardiovascular Therapy Collaboration, GE Healthcare Launches Multifunctional Cell Processing System, and FDA places PaxVax’s phase 2 chikungunya shot on its fast track.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
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…
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“…
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…
Continuous bioprocessing presents many exciting opportunities for improving biomanufacturing. Frequently discussed are methods for incorporating Process Analytical Technology (PAT) initiatives into a continuous operation. One advantage of implementing PAT in continuous bioprocessing operations is the opportunity to not just analyze what has happened, but to make real-time process control adjustments for increased quality assurance and greater process efficiency…
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…
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...
Cell Culture Heroes – Webinars on Cancer Research
Gibco Cell Culture Heroes spotlights PhD and post-doc cancer researchers across the globe with the primary focus of telling the story of their research. This program promotes education and creates a community amongst researchers who are driving tomorrow’s breakthroughs in the fight against cancer.
As a Gibco Cell Culture Hero you can present your research to a global audience via webinar and you will have the opportunity to share your story of success and perseverance to the world on thermofisher.com.
Do you want your research to be highlighted as a Cell Culture Hero? Click here to learn more – https://www.thermofisher.com/us/en/home/products-and-services/promotions/life-science/cell-culture-heroes.html
Join MilliporeSigma and your peers for the Emerging Biotech Upstream Forum to discuss latest trends, innovations, and technologies to accelerate your upstream process development: from cell line development to bioreactor scale up.
Tuesday, May 22, 2018 – Rockville, MD – Register
Thursday, May 24, 2018 – Cambridge, MA – Massachusetts Biotechnology Council – Register
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-d
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.
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:
“Takeda Pharmaceutical agreed to buy London-listed Shire for 45.3 billion pounds ($62 billion) on Tuesday, the biggest yet in a wave of deals sweeping the drugs industry. Assuming it wins the backing of shareholders, the deal will be the largest overseas purchase by a Japanese company and propel Takeda, led by Frenchman Christophe Weber, into the top 10 rankings of global drugmakers…”
“The Food and Drug Administration said on Wednesday that it was seeking court orders to stop two clinics from using unapproved stem cell treatments that in some cases have seriously harmed patients. The clinics remove fat from patients’ bellies by liposuction and then inject an extract of it into various parts of the body like knees or the spinal cord, on the theory that the extract contains stem cells that can provide replacement cells that will repair the damage from injury or illness…”
“Looking at human cells isn’t as simple as it sounds, especially when scientists want to examine clearly, in 3D, how multiple structures change over a time while cells are alive. Now, the Allen Institute for Cell Science has created a new tool, enabled by machine learning, that ticks all those boxes. Meet the Allen Integrated Cell, “a new way to see inside living human cells,” as Rick Horwitz, Ph.D., executive director of the Allen Institute for Cell Science, put it…”
“AstraZeneca, SWIBCo Launch Stem Cell Cardiovascular Therapy Collaboration,” Genetic Engineering News
“AstraZeneca will develop novel cardiovascular and catheter-based therapies using Procella Therapeutics’ stem cell technology and Smartwise’s catheter injection method, it was disclosed today, through a collaboration that could generate up to $320 million-plus for the parent company of the pharma giant’s partners…”
“GE Healthcare Life Sciences launches the Sefia S-2000 cell processing system, a multifunctional technology allowing operators the flexibility to conduct multiple Cell Therapy manufacturing steps with one instrument. The Sefia instrument paired with dedicated software and disposable kits enables operators to set the software to automate an individual cell processing step or a series of steps. Many of the Cell Therapy manufacturing process steps remain largely disconnected and require a human operator to manually transfer cells from step to step, leading to more opportunities for contamination.”…
“Working against a disease with no available vaccines, PaxVax has picked up an important regulatory boost from the FDA for its chikungunya shot. The agency blessed the candidate with its Fast Track Designation, meaning extra regulatory assistance on a path toward a possible approval. The designation grants drug and vaccine developers perks including more frequent meetings and written communications with agency personnel, eligibility for accelerated approval and priority review, plus the ability to submit portions of their applications at a time rather than all at once, according to the FDA…”