This week’s headlines include: Zika virus wipes out two types of brain tumors in mice, Access to Biosimilars in EU Expected to Continue to Outpace US and Canada, CAR-T therapy could be available to NHS patients this year, Breakthrough Therapy Designation Is Granted by FDA for Pfizer’s MenB Vaccine In Children, and U.S. court upholds dismissal of $200 million Merck verdict against Gilead.

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

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…

Insights and Innovations From the 2018 World Vaccine Congress

For the past 18 years, the World Vaccine Congress has played a prominent role in educating biotech industry leaders on the latest research, innovations, and advocacy in vaccine development. This year’s World Vaccine Congress took place April 2 – 5 in Washington D.C., with 1000+ attendees, 250+ speakers, and 60+ exhibitors. According to a conference organizer, this year’s congress was both the largest and most successful event to date, with a ~25% increase in overall attendance…

Bioprocessing Technologies for Stem Cell Therapy Manufacturing

In this podcast and accompanying article, we interviewed Ricardo Baptista, Lead Process Development Scientist, Cell and Gene Therapy Catapult, UK about his impressions on current bioprocessing technologies for stem Cell Therapy manufacturing and possible future innovations…

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…

Integrating Downstream Unit Operations – Polishing and Concentration Steps

Most downstream biomanufacturing process steps are conducted as separate unit operations. As such, there are a great number of manual tasks including individual instrument function, intermediate handling of material, and product transfer. This high reliance on manual tasks consumes more resources and introduces greater opportunity for operator error…

Webinar:

Ensure Integrity of Your Single-Use Systems

Date & Time: Thursday, April 26, 2018:  8:00 AM BST / 9:00 AM CEST / 12:30 PM IST / 3:00 PM SGT / 4:00 PM JST

Date & Time: Thursday, May 3, 2018:  8:00 AM PDT / 10:00 AM CDT / 11:00 AM EDT

In this 45-minute webinar, experts from Pall Biotech will discuss the approach and strategy to ensure the highest level of assurance of integrity of SUS in drug substances and drug products processes. They will take into account the life cycle of the SUS; from its manufacturing to end user’s deployment and use.

You will learn about:

• The industry trends and recommended approach for the assurance of integrity of single-use systems
• Available solutions for the highest level of assurance of integrity of SUS
• A new integrity test for Allegro 2D biocontainer assemblies

To learn more, click Register

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 mosquito-borne virus Zika ignited fears around the world more than two years ago due to its link to children born with the brain malformation known as microcephaly. But a handful of cancer researchers see potential in exploiting the Zika virus’ ability to infect the brain. Among them is a team at the University of São Paulo in Brazil, which is reporting promising evidence that the virus may be useful in treating two types of childhood brain tumors…”

“Biosimilar experts from across the EU continued to show how rapidly biosimilars have gained market share, in contrast to US and Canadian markets. Keith Ridge, chief pharmaceutical officer at NHS England, told attendees of the 6^th annual Biosimilar Medicines Conference in London on Thursday that the UK has seen increasing uptake of rituximab, infliximab and etanercept biosimilars, particularly in London. For instance, a biosimilar for infliximab, which came to market in March 2015 is now used by about 80% of patients on the medicine in the UK…”

“CAR-T therapy could be available to NHS patients this year,” PharmaTimes

“NHS England chief executive Simon Stevens has indicated that chimeric antigen receptor T-Cell Therapy (CAR-T) could be available on the NHS this year, offering eligible patients a ‘ground-breaking’ approach to treating cancer. Addressing the Association of the British Pharmaceutical Industry’s annual conference in London, he said “preparations are underway to make CAR-T, one of the most innovative treatments that has ever been offered on the NHS available to patients.”

“Breakthrough Therapy Designation Is Granted by FDA for Pfizer’s MenB Vaccine In Children,” MD Magazine

“Drug giant Bristol-Myers Squibb is partnering with Illumina, the leading maker of DNA sequencing gear, to develop diagnostic tests that will pair with Bristol’s cancer drugs. One of the first tests will be for tumor mutation burden, a measure of how much a tumor’s DNA has changed compared to the patient’s healthy cells. Cancer drugs that target the immune system, like Bristol’s Opdivo (2017 sales: $4.9 billion) and Yervoy (2017 sales: $1.2 billion), may work better in patients where the tumor mutation burden is higher, because this may make the cancer easier for the immune system to “see…”

“U.S. court upholds dismissal of $200 million Merck verdict against Gilead,” Reuters

“A U.S. appeals court on Wednesday affirmed a ruling that pharmaceutical company Merck & Co dishonestly obtained patent rights and was not entitled to collect a $200 million infringement verdict it won against rival Gilead Sciences Inc…”