This week’s headlines include:  Scripps Research, AbbVie join in large cancer therapy alliance, GE Healthcare Spun Off as a Standalone Company, House passes bipartisan bill to fight opioid crisis, NICE backs Roche’s Alecensa, High-Resolution Snapshot of Zika Virus Reveals Clues to Fighting It, and Poliovirus treatment for glioblastoma posts ‘encouraging’ survival data, but work remains.

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

Expansion of Mesenchymal Stem Cells in Blood-free, Chemically Defined Media

Last month’s ISCT conference held in Montreal, Canada featured many novel approaches for cell therapy research and manufacturing. One of the posters presented at the conference, “Inclusion of Recombinant Albumin and Transferrin Enables the Blood-Free Expansion of Mesenchymal Stem Cells in Chemically Defined Media,” highlighted the importance of blood-component free media for cell therapies and provided data on the use of a blood-free media in mesenchymal stem cell (MSC) culture…

Cell Based Influenza Vaccines – Are eggs finally on the way out?

With initial data from the 2017-2018 flu season indicating around 20% better protection from the cell culture manufactured Flucelvax flu vaccine, will the industry begin to move away from eggs and toward cell based influenza vaccines? Seven years ago I wrote an article called, “Is Egg-based vaccine manufacturing on its way out”. Since then there have been two cell based influenza vaccines approved for use in the United States, Flucelvax manufactured in MDCK cells by Seqirus and FluBlok manufactured in insect cells from Sanofi. However, the vast majority of the vaccines administered in the United States still use egg-based manufacturing. This trend may change in coming years, as 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 potential for fewer virus mutations and thus a more effective vaccine…

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…

Start With the End in Mind – How to facilitate transfer from non-GMP to GMP Manufacturing

In this podcast and accompanying article, we interviewed Avril Vermunt, bioprocess hardware specialist at GE healthcare about transferring a process from non-GMP to GMP manufacturing, particularly how resource-intensive it is for process development and manufacturing groups. Avril has several years of experience working in the technology transfer group at a large pharmaceutical company. We discussed with her best practices and how being proactive and one step ahead can make the process more seamless…

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.

Conferences:

Cell & Gene Therapy Bioprocessing & Commercialization – September 4 – September 7, 2018

Bringing together 300+ leaders and key influencers from pharma and biotech companies this September in Boston, Cell & Gene Therapy Bioprocessing & Commercialization 2018 will provide you with the latest advice for driving manufacturing and commercialization through direct access to innovative discovery, product development and regulatory know-how. Discover everything you need in one place as you move between 4 tracks jam packed with topical talks and industry case studies, and meet with colleagues for an unrivalled on-site experience.

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 nonprofit Scripps Research Institute has landed a major deal with pharma giant AbbVie for its improved version of an immune therapy for cancer. Although financial terms weren’t disclosed, the deal requires antitrust review, the parties said in a statement released Monday. Under the law, antitrust review must be given to deals worth more than $84.4 million. AbbVie gets exclusive rights to the technology for four years…”

“To no one’s surprise GE has rapidly completed its strategic review. The move comes after the S&P Dow Jones Indices recently removed the company from the Dow Jones Industrial Average. GE will focus on aviation, power, and renewable energy, creating a simpler, stronger, leading high-tech industrial company, according to John Flanner, chairman and CEO of GE. In addition to the pending combination of its transportation business with Wabtec, GE plans to separate GE Healthcare into a standalone company, pursue an orderly separation from BHGE over the next two to three years, make its corporate structure leaner, and substantially reduce debt, noted Flanner…”

“The House on Friday passed bipartisan legislation aimed at fighting the nationwide epidemic of opioid abuse, culminating months of work on the crisis. The measure, which passed 396 to 14, is the broadest of dozens of bills on the topic passed by the House over the past two weeks…”

“NICE backs Roche’s Alecensa,” PharmaTimes

“Roche’s Alecensa has won NICE backing as a treatment for a rare type of lung cancer, over-turning a prior decision to reject NHS funding for the drug. In draft guidelines, the Institute is now endorsing the drug, within its marketing authorisation, as an option for untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), which affects around 925 people in England…”

“High-Resolution Snapshot of Zika Virus Reveals Clues to Fighting It,” The New York Times

“Scientists have captured the clearest and most detailed image yet of Zika, the virus that set off a global health crisis in 2015 and 2016 and left thousands of babies with serious birth defects. The work could contribute to the development of more effective vaccines and treatments to combat the virus…”

“Poliovirus treatment for glioblastoma posts ‘encouraging’ survival data, but work remains,” FierceBiotech

“Duke University’s poliovirus-based glioblastoma treatment burst on the scene in 2015, thanks to the CBS show “60 Minutes.” At the time, only a few patients had received the treatment, and it was unclear if a virus would even work against brain tumors. Now, the scientists behind it are reporting an “encouraging” long-term survival rate in patients with recurrent glioblastoma…”