This week’s headlines include: A Common Virus May Play Role in Alzheimer’s Disease, Study Finds, Bluebird’s Upgraded Gene Therapy Shows Promise For Sickle Cell Patients, Bipartisan group of senators asks FDA to examine drug shortages, Sanofi Agrees to Transfer Infectious Disease Unit, 100 Employees to Evotec, Amgen’s Blincyto gets full EU approval for rare leukaemia, and Roche pays $2.4 billion for rest of cancer expert Foundation Medicine.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
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…
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…
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…
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…
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 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…
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…
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“…
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
Gibco Cell Culture Heroes spotlights PhD and post-doc cancer researchers across the globe with the primary focus of telling the story of their research. This program promotes education and creates a community amongst researchers who are driving tomorrow’s breakthroughs in the fight against cancer.
As a Gibco Cell Culture Hero you can present your research to a global audience via webinar and you will have the opportunity to share your story of success and perseverance to the world on thermofisher.com.
Do you want your research to be highlighted as a Cell Culture Hero? Click here to learn more – https://www.thermofisher.com/us/en/home/products-and-services/promotions/life-science/cell-culture-heroes.html
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-d
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.
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.
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:
“It has long been a controversial theory about Alzheimer’s disease, often dismissed by experts as a sketchy cul-de-sac off the beaten path from mainstream research.But a new study by a team that includes prominent Alzheimer’s scientists who were previously skeptics of this theory may well change that. The research offers compelling evidence for the idea that viruses might be involved in Alzheimer’s, particularly two types of herpes that infect most people as infants and then lie dormant for years…”
“Bluebird Bio has new clinical data this morning that, while early and only from a handful of patients, are the most significant evidence to date that gene therapy might help people with sickle cell disease, a genetic disorder without an effective treatment that afflicts millions around the world…”
“A bipartisan group of senators is asking the head of the Food and Drug Administration (FDA) to provide recommendations to Congress on how to address nationwide drug shortages…”
“Sanofi Agrees to Transfer Infectious Disease Unit, 100 Employees to Evotec,” Genetic Engineering News
“Sanofi has agreed to transfer its infectious disease unit, and most of its research portfolio and initiatives, to Evotec for more than €60 million (nearly $70 million), in a deal that Evotec said today will more than double its workforce in the indication, and will transform it into a leading developer of anti-infective treatments…”
“European regulators have awarded Amgen’s Blincyto full approval for Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow thought to affect around 900 patients a year in the region…”