This week’s headlines include: Merck takes key step toward approval of experimental Ebola vaccine, New drug options, risk factors added to U.S. heart guidelines, A gut bacterium as a fountain of youth? Well, let’s start with reversing insulin resistance, FDA chief: Blood pressure medicine recalls reflect increased scrutiny on drug safety, AbbVie, Mission Therapeutics join forces on Alzheimer’s, Parkinson’s, and RoosterBio Submits U.S. FDA Master Files for CliniControl™ Line of Human Mesenchymal Stem/Stromal Cell Products.

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

Cell Harvesting Technologies – Which is best for your process?

Cell harvesting is a critical step in connecting upstream monoclonal antibody production with downstream purification. Selecting the best cell harvesting technology based on the characteristics of the cell culture process can be challenging. This decision is made early in process development and requires a good understanding of both the current process and the advantages/disadvantages of the various cell harvesting technologies available…

Large Scale Adenovirus Production for Gene Therapy Manufacturing

Gene therapy is one of the most promising developments in medicine. It has the potential to treat many diseases by using a gene-modifying technology to repair, replace or correct genetic damage in the body. Last year was an important year for advancing gene therapy with two pioneering Chimeric Antigen Receptor T Cell (CAR T) cell therapies for cancer approved in the US: Novartis’ Kymriah^® and Kite/Gilead’s Yescarta^® and Spark’s Luxturna^® was approved to correct a retinal disease…

Biologicalisation is Coming of Age

One of this year’s Nobel Prize in Chemistry winners was Frances H. Arnold.  This Linus Pauling Professor at the California Institute of Technology had invented systems for the directed evolution of enzymes that are now routinely used to, e.g., develop catalysts for manufacturing.  Importantly, this includes supporting more environmentally friendly manufacturing of such chemical substances as pharmaceuticals and renewable fuels [1].  This event could be considered an inauguration of a much larger recent initiative to transform our manufacturing methods by the incorporation of biological and bio-inspired principles, materials and functions.  It’s noteworthy that this is only the fifth woman in history to have received the prize in Chemistry.  As it is her work that promises to contribute to this next revolution in manufacturing, we find it emblematic of our long-neglected recognition of women’s contribution in science…

Rapid Real-Time PCR-based Mycoplasma Testing for In-Process Control and Lot Release

In this mini-webinar and accompanying article, Martina Sauert, PhD and Carl-Ulrich Zimmerman, PhD of Mycoplasma Biosafety, an independent service provider specialized in the field of mycoplasma testing, discuss the shortcomings of traditional mycoplasma testing methods and the risks associated with mycoplasma contamination in biomanufacturing. They share the manufacturing points where mycoplasma testing is required by regulators and how rapid real-time PCR-basedtesting systems permit in-process mycoplasma testing as part of a quality by design (QbD) approach…

State of the Art CO2 Incubators Offer Safe Haven for Sensitive Cells

Cell culture CO2 incubators are a critical part of the cell culture process as cells spend most of their time here. The CO2 incubator’s purpose is to create ideal living conditions for cells to thrive, however this is not always achieved, sometimes not even visible at first glance. Environment variation and contamination are common challenges and both can cause experimental variation. Experimental variation can compromise years of research and investment. With sensitive cells, such as stem cells and primary cells, the amount of variation it takes to make an impact on cell health is decreased…

Rapid Characterization of Virus Like Particles Informs Vaccine and Gene Therapy Downstream Processes

When working with viral systems, either during manufacture of viral-based vaccines or gene therapies, having the right analytics is crucial. This is particularly true when optimizing downstream processes and in characterizing product lots for purity. Information on the amount of virus like particles present, particle structure and their biological impact not only informs the manufacturing process, but also final product purity and quality. While these answers are important they are not always easy to access. The following case study demonstrates the use of the MiniTEM as a convenient analytical, direct-measurement method to characterize virus like particles (VLPs) or virus preps. While this case study focuses on influenza vaccine, it is important to note that this is just one example and that the technology could be used in many viral-based vaccine or viral vector manufacturing scenarios…

A Guide for Selecting the Correct Filter Integrity Test Instrument

Selecting the right filter integrity test instrument is an important task. An informed, balanced choice will support the seamless integration of the instrument into critical processes and provide trouble-free operation for years to come. The right choice may be made more difficult by different departments, or user groups, who may assign a different value to the same feature. A rational approach is beneficial to ensure the selected instrument can fulfill all the selection criteria for all interested parties, with any compromises being limited to non-critical characteristics…

Downstream Manufacturing of Gene Therapy Vectors

The goal of downstream processing is to separate the viral vector from the various impurities produced during upstream processing and to get the virus into the appropriate state for formulation and administration to patients. Viral vector batches destined for clinical use must comply to increasing regulatory standards for impurities and contaminants as these can affect product safety and potency. In addition to providing purity, purification processes need to meet production scale, which can be quite large for clinical trials and commercial applications…

How Robots Are Changing The Landscape Of The Medical Field

Robotics are becoming increasingly present in many different industries. In the medical world, robots and AI are helping medical professionals conduct procedures, understand the risk of surgical complications, and provide more precise patient care….

Continuous biomanufacturing – Key drivers for adoption, economic modelling and regulatory considerations

The Medicine Maker recently published a multi-authored eBook on Continuous Biomanufacturing, titled, “The Continuous Way”. The publication includes seven articles covering the topic of continuous biomanufacturing from a variety of angles. I really enjoyed the eBook and it provided a great update on the current state of continuous biomanufacturing as well as information about key drivers for adoption, new economic modeling, and integration of continuous operations. Following is a sampling of articles with key highlights…

Headlines:

“Merck said Tuesday that it has begun the process of submitting the evidence it will use to seek approval for its experimental Ebola vaccine, a crucial step in the drug maker’s long effort to bring the vaccine to market…”

“New drug options, risk factors added to U.S. heart guidelines,” Reuters

“Updated U.S. guidelines on heart health advise more personalized assessment of risk as well as two newer types of cholesterol-lowering drugs for people at particularly high risk of heart attack or stroke…”

“A gut bacterium as a fountain of youth? Well, let’s start with reversing insulin resistance,” Los Angeles Times

“Move over Bifidobacterium and Lactobacillus. There’s a new health-promoting gut bacterium in town, and it’s called Akkermansia muciniphila. You will not find its benefits at the bottom of a yogurt cup. But a new study has identified more than one way to nurture its growth in the gut, and offered evidence that it may maintain — and even restore — health as we age…”

“FDA chief: Blood pressure medicine recalls reflect increased scrutiny on drug safety,” USA Today

“The head of the Food and Drug Administration says the agency is increasing its focus on drug quality to guard against impurities such as the potentially cancer-causing chemicals that have been found in three commonly prescribed blood pressure medications…”

“AbbVie, Mission Therapeutics join forces on Alzheimer’s, Parkinson’s,” FierceBiotech

“AbbVie and Mission Therapeutics inked an R&D pact focused on deubiquitylating enzymes (DUBs) in Alzheimer’s and Parkinson’s disease…”

“RoosterBio Submits U.S. FDA Master Files for CliniControl™ Line of Human Mesenchymal Stem/Stromal Cell Products,” PR Web

“RoosterBio Inc, a leading supplier of human Mesenchymal Stem/Stromal Cell (hMSC) working cell banks and hMSC-specific bioprocess systems, announces today it has submitted a U.S. Food and Drug Administration (FDA) Type II Master File (MF) for its CliniControl™ line of cGMP hMSC working cell banks. This MF complements the MF for the CliniControl RoosterNourish™-MSC-CC bioprocess media that was filed in 2017. The MFs contain confidential information on the products including their chemistry, manufacture, and controls. This enables RoosterBio to protect proprietary product information yet allows the FDA to review the information in support of an investigator’s submission. Upon request, RoosterBio will grant a customer authorization to cross reference the stated MF(s) to support their own regulatory filing, such as an Investigational New Drug (IND) application to the FDA. INDs are filed with the FDA prior to beginning clinical evaluation of new therapeutic products in human subjects…”