This week’s headlines include: Trump says drug companies to announce ‘massive’ price cuts soon, FDA puts Vertex, CRISPR sickle cell trial on hold, Trump signs ‘right to try’ drug bill, Research Suggests How A Common, Serious Side-Effect Of CAR T-Cell Therapy May Be Preventable, Who gets credit for CRISPR? Prestigious award singles out three, and leaves out a notable scientist, and Trio of genes supercharged human brain evolution.

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

Successful Mesenchymal Stem Cell Manufacturing for Cell Therapy Applications

In this podcast and accompanying article, we interviewed Dr. Ross Macdonald, CEO Cynata Therapeutics, about the use of mesenchymal stem cells for Cell Therapy applications and key criteria for successful mesenchymal stem cell manufacturing…

Mycoplasma Contamination – Early Detection and Elimination Can Ensure Research Validity

How big of a problem is mycoplasma contamination? The answer is very big. A variety of studies conducted worldwide have found that mycoplasma contamination in laboratory cultures varies from 15-80% (1). Mycoplasma contamination is a very real concern for research labs, largely due to the fact that contamination can impact cells’ behavior and thus compromise the validity of experimental results and study data. In fact, this widely recognized problem has led many research publications to require authors prove that the cells used in their studies are free of mycoplasma contamination…

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…

Impurity Precipitation Strategies for Intensification of mAb Downstream Processes

Impurity precipitation is focused on process- and product-related impurities which have to be removed during the downstream process in the manufacturing of therapeutic proteins. Common impurities are host cell proteins, DNA as well as aggregates of the therapeutic protein. Moreover, the purification process must include steps which are able to inactivate or remove viruses to ensure the viral safety of the biopharmaceutical…

Implementing Process Analytical Technology (PAT) in Continuous Bioprocessing

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…

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…

Webinars

Finding the Common Road to Quality for Single-use Materials

Cell Culture Heroes – Webinars on Cancer Research

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:

“President Donald Trump on Wednesday said he expects major drug companies to slash prices on their products in two weeks, but did not provide details on which companies would do so or how such reductions would be made…”

“The FDA has placed a clinical hold on Vertex and CRISPR Therapeutics’ sickle cell disease candidate. Shares in CRISPR fell 15% as investors digested the delay to the start of the gene-editing startup’s first U.S. clinical trial. CRISPR and Vertex filed to run a U.S. phase 1/2 trial in adults with sickle cell disease last month with a view to starting the study later this year. That target may now be in jeopardy, although the lack of details shared by CRISPR and Vertex to date means the impact of the clinical hold on autologous gene-edited hematopoietic stem Cell Therapy CTX001 is unclear…”

“President Trump signed a bill Wednesday allowing terminally ill patients access to experimental medical treatments not yet approved by the Food and Drug Administration (FDA). Dubbed “right to try,” the law’s passage was a major priority of Trump and Vice President Pence, as well as congressional Republicans…”

“Research Suggests How A Common, Serious Side-Effect Of CAR T-Cell Therapy May Be Preventable,” Forbes

“It has been a good month for CAR T-Cell therapies. On May 1st, the FDA handed out an approval to Novartis’s controversially-priced Kymriah for treating adults with certain types of non-Hodgkin lymphoma. Today, simultaneous discoveries from scientists in both New York and Milan were published in Nature Medicine, describing how the most common, life-threatening side effect of these therapies, called cytokine release syndrome (CRS) might be averted…”

“Who gets credit for CRISPR? Prestigious award singles out three, and leaves out a notable scientist,” STAT

“One of the world’s richest science awards, given only in alternate years, will go to three discoverers of the CRISPR-Cas9 genome-editing tool, the Norwegian Academy of Science and Letters announced on Thursday. Emmanuelle Charpentier of the Max Planck Institute for Infection Biology, Jennifer Doudna of the University of California, Berkeley, and Virginijus Šikšnys of Vilnius University will each receive a gold medal and share the $1 million that comes with the Kavli Prize in nanoscience (there are also Kavli prizes for astrophysics and neuroscience)…”

“Trio of genes supercharged human brain evolution,” Science

“Three nearly identical genes could help explain how 0.5 liters of gray matter in early human ancestors became the 1.4-liter organ that has made our species so successful and distinctive. The newly identified genes could also help explain how brain development sometimes goes wrong, leading to neurological disorders…”