This week’s headlines include: Experimental Ebola Treatments Approved for the Democratic Republic of Congo, Genentech, Microbiotica to Develop Microbiome-Based IBD Treatments, Could an old Amgen-developed RA drug make CAR-T treatments safer?, FDA wants to shorten new drug monopolies to cut costs, Wall Street Is More Optimistic on Amgen’s Next Blockbuster Drug, and Nipah Virus, Rare and Dangerous, Spreads in India.

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

Knowledge Sharing is Key to Future Breakthroughs in Cancer Research

PhD and post-doc cancer researchers are being recognized as cell culture heroes in a new program that provides a platform to promote education and share knowledge among the researchers who are driving breakthroughs in the fight against cancer.

Cancer is defined as a disease caused by an uncontrolled division of abnormal cells that can affect any part of the body, with well over 200 different types of cancer identified to date. It is one of the world’s biggest killers, with approximately 14 million new cases and 8.2 million deaths a year.

New Technologies and Trends in Cell Line Development

Informa’s Cell Line Development and Engineering conference last month was full of pharmaceutical companies and solutions providers sharing best practices, innovative solutions and emerging trends in Cell Line Development.

I was pleased to attend the conference and wanted to share some highlights.

Acoustic Cell Processing Helping to Industrialize Cell and Gene Therapy

In this article, acoustic cell processing, a unique platform technology that allows for the manipulation of cells with nearly shear-free and low power ultrasonic standing waves, is discussed with its application to cell and Gene Therapy manufacturing illustrated through case studies.

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…

Modeling Downstream Disruptive Technologies to Improve Downstream Bioprocessing

In this podcast and accompanying article we interviewed Dr. Yuyi Shen, Principal Scientist, Grifols about the benefits of modeling downstream disruptive technologies to improve downstream bioprocessing and evaluating the financial impact of implementing these technologies.

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“…

Webinars

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:

“The Democratic Republic of Congo said Wednesday it has approved the use of five experimental Ebola treatments on patients suffering from the hemorrhagic fever, as drug companies and health workers scramble to use the current outbreak to help find a cure for the deadly virus…”

“Genentech, a member of the Roche Group, will partner with Microbiotica to discover, develop, and commercialize microbiome-based biomarkers and therapies for inflammatory bowel disease (IBD), through a collaboration that the Wellcome Trust Sanger Institute spinout said today could generate for it up to $534 million-plus…”

“The personalized CAR-T cells that are FDA-approved to treat blood cancers, Gilead’s Yescarta and Novartis’s Kymriah, can raise the risk of a side effect that has been challenging to prevent and treat: cytokine release syndrome (CRS)…”

“FDA wants to shorten new drug monopolies to cut costs,” Reuters

“In an effort to increase competition and bring down prescription drug prices, FDA Commissioner Dr. Scott Gottlieb wants to speed approval times for rivals to promising new first-to-market medicines. The U.S. Food and Drug Administration chief has made a commitment to speeding up approvals of cheap generic medicines, which he said is his agency’s main contribution to the Trump administration’s push to cut drug costs to consumers. Gottlieb said the primary effort is being led by the Department of Health and Human Services…”

“Wall Street Is More Optimistic on Amgen’s Next Blockbuster Drug,” Bloomberg

“For Amgen Inc., the launch of its next would-be blockbuster medicine may be a chance to avoid pitfalls of the past. After sales of heart drug Repatha finally showed signs of traction in last month’s quarterly earnings, investors are focusing on Amgen’s first-in-class migraine therapy as the stock seeks to recover from a rough few months for mature biotech companies…”

“Nipah Virus, Rare and Dangerous, Spreads in India,” The New York Times

“A rare, brain-damaging virus that experts consider a possible epidemic threat has broken out in the state of Kerala, India, for the first time, infecting at least 18 people and killing 17 of them, according to the World Health Organization…”