This week’s headlines include: A Crispr Conundrum: How Cells Fend Off Gene Editing, Hydrogel could enable pancreatic islet transplants for diabetes, With $45M Translate Bio Deal, Sanofi Bets Again on mRNA Vaccines, White House Preparing Bio-Defense Strategy As Germ Warfare Fears Rise, Pfizer to pump $600 million in additional funding into biotech startups, and Kids in U.S. “hotspots” most vulnerable to vaccine-preventable disease, research finds.

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

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.

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.

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

Using Blood-Free Insulin, Transferrin, and Albumin Supplements to Reduce and Eliminate FBS in Research & Manufacturing

Thursday June 28th 12-1pm MT

See How Blood-Free Supplements Add Consistency & Reduce Variability

It is well known that serum and other animal-derived components can create inconsistency in cell culture, leading to variability in cell growth, phenotype, and functional performance. Therefore, it is critical to both manufacturing and research applications to reduce or completely eliminate the use of these ingredients.

InVitria offers blood-free cell culture supplements that effectively reduce the amount of serum needed in routine cell culture by replacing the insulin, transferrin, and albumin found in serum with recombinant versions. These supplements, known as ITSE AF, ITS AF, and ITSE + A AF, also serve as a suitable foundation for fully serum and blood-free cell expansion.

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:

“Human cells resist gene editing by turning on defenses against cancer, ceasing reproduction and sometimes dying, two teams of scientists have found. The findings, reported in the journal Nature Medicine, at first appeared to cast doubt on the viability of the most widely used form of gene editing, known as Crispr-Cas9 or simply Crispr, sending the stocks of some biotech companies into decline on Monday…”

“Scientists searching for Type 1 diabetes cures have long been interested in transplanting functioning pancreatic islet cells into patients, but the danger of immune system rejection has been an obstacle. A team from from Georgia Tech, the University of Louisville and the University of Michigan, however, transplanted islets into mouse models of diabetes, along with a hydrogel that trains immune cells to accept the transplants…”

“It hasn’t been proven yet that synthetic messenger RNA molecules (mRNA) can be effective medicines. But their promise as a source for new vaccines, primarily for cancer, has enticed multiple pharmaceutical companies. The latest evidence comes from Sanofi, which just cut its second mRNA vaccine deal to date, this time with Translate Bio…”

“White House Preparing Bio-Defense Strategy As Germ Warfare Fears Rise,” Forbes

“The National Security Strategy released by the Trump Administration in December makes deterring and/or defeating “weapons of mass destruction” a top priority for U.S. policymakers. In the past, that phrase has almost always been used as a euphemism for nuclear weapons. But in a break with tradition, the administration is putting increased emphasis on combating bio-threats and pandemics. In fact, the National Security Council staff is preparing a dedicated bio-defense strategy…”

“Pfizer to pump $600 million in additional funding into biotech startups,” New York Business Journal

“The New York-based pharmaceutical giant (NYSE: PFE) unveiled plans Wednesday to invest $600 million into emerging growth companies through its venture capital arm, Pfizer Ventures. The move likely will include a hiring spree, as Pfizer looks to expand its team across several areas of venture capital investing, including business development, drug discovery and clinical development…”

“Kids in U.S. “hotspots” most vulnerable to vaccine-preventable disease, research finds,” CBS News

“A rise in non-medical exemptions from childhood vaccinations in certain areas of the United States has created several geographic “hotspots” where children are more vulnerable to preventable disease outbreaks, new research finds. While some children cannot be fully vaccinated for medical reasons, others are not vaccinated because of their parents’ religious or philosophical beliefs. A major reason behind choosing not to vaccinate children for philosophical reasons is the erroneous and disproven claim that vaccines cause autism…”