This week’s headlines include: Novartis strikes deal with Chinese firm to make Kymriah, Gene tweak kills whole population of malaria-carrying mosquitoes in lab, Congratulations. Your Study Went Nowhere, Gilead to Make Generic Hepatitis C Drugs and Cut Prices Up to 75%, With new blood test, Roche dives deeper into personal cancer care, and T-cell therapy for eradicating HIV reservoirs proves safe in small study.

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:

Upcoming Conferences

Speed to IND for Biologics

October 17-18, 2018, Argonaut Hotel, San Francisco CA

CBI’s Speed to IND for Biologics provides a comprehensive, cross-functional format that brings together experts from every department to share their perspectives, achievements and lessons learned as a community working towards the common goal of accelerating speed while managing and mitigating risk.

CELL SERIES

The annual Cell Series features 4 outstanding programmes: our long-running 7^th Cell Culture and Bioprocessing, 5^thStem Cell & Regenerative Medicine, 4th Cell and Gene Therapy and Biobanking Congresses. The Cell Series provides a focused networking platform targeting Cell Culture & Cell Line Development and Bioprocessing; Cell & Gene Therapy highlighting CAR T Cell Development; Stem Cell & Regeneration Medicine Development as well as Biobanking.

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

Isolation of Mononuclear and Polymorphonuclear Leukocytes from Blood with Density Separation Media

Blood is a specialized body fluid composed of four main components: plasma, white blood cells (leukocytes), red blood cells (erythrocytes), and platelets (thrombocytes). Unlike red blood cells and platelets, all white blood cells are nucleated and can be classified by their nuclei structure as mononuclear or polymorphonuclear cells…

Biotech Week Boston 2018: Cell and Gene Therapy Bioprocessing and Commercialization Highlights

Biotech Week Boston, held at the Hynes Convention Center in Boston, MA, was a fantastic amalgamation of scientific conferences, training courses, and keynotes all focused on cell bioprocessing. The theme of this year’s Cell and Gene Therapy Bioprocessing and Commercialization conference was “transforming innovative research to drive the future of cell & gene therapy by relieving bottlenecks and pain points in clinical development, manufacture and commercialization of cell, gene and immunotherapies”…

Overview of the Regulatory Path to Commercializing a Gene Therapy

After decades of research, gene therapies now comprise much of the R&D and manufacturing pipelines in the United States and around the world. Huge strides in biological understanding and the development of key enabling technologies are at long last delivering on the promises of precision and personalized medicines. While there is still much more to learn and develop, regulatory constructs keeping pace with the speed of innovation remains a sizeable challenge…

A Defined Synthetic Growth Surface for Stable hiPSC Expansion

hiPSCs cultivation can be challenging with lot-to-lot coating variations, tedious preparation and increased contamination risk. In particular, biological coatings may negatively impact downstream applications due to the presence of undefined extracellular matrix (ECM) components and growth factors. Another common struggle is decreased reproducibility of data due to an inherently complex and non-defined growth surface. To address these common challenges, Eppendorf has introduced a ready-to-use consumable with synthetic fibronectin-derived motifs to support stem cell attachment by mimicking the native ECM protein fibronectin. The FN1 motifs surface allows expansion of stem cells in various xeno-free media and other restrictive culture conditions. Thus, you can establish a completely defined culture system for your stem cell culture without any animal or human components…

Key Considerations for Gene Therapy Commercialization

Gene therapy is the use of a gene-modifying technology to repair, replace or correct damage in the body. The first approved gene therapy study was conducted by the National Institutes of Health (NIH) in 1989 and provided evidence for the first time that human cells could be genetically modified and returned to the patient without harm. To date, approximately 2,600 clinical trials and six gene therapy products have been approved in various countries…

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…

Cool Tool – Inline Diafiltration Closes the Gap for End-to-End Continuous Bioprocessing

Diafiltration, while fulfilling several functions in protein purification, has also presented a major obstacle in achieving continuous biomanufacturing. Technologies launched over the last decade have moved the industry closer to completing an integrated end-to-end continuous bioprocessing platform; however adequately addressing continuous final ultrafiltration/diafiltration of drug substance has been challenging. Now, inline diafiltration offers a solution to both traditional bottleneck hurdles and continuous biomanufacturing platform gaps…

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…

Headlines:

“2018 Nobel Prize in Medicine Awarded to 2 Cancer Immunotherapy Researchers,” The New York Times

“The Nobel Prize in Physiology or Medicine was awarded on Monday to James P. Allison of the United States and Tasuku Honjo of Japan for their work on unleashing the body’s immune system to attack cancer, a breakthrough that has led to an entirely new class of drugs and brought lasting remissions to many patients who had run out of options…”

“Kite adds to T-cell receptor platform with HiFiBiO deal,” FierceBiotech

“Gilead’s Kite is paying $10 million upfront to tap into a neoantigen screening platform developed by Hong Kong biotech HiFiBiO Therapeutics to discover T-cell receptors (TCRs) for cancer. The two companies say they will adapt the platform to scale up and accelerate the screening process so that it can be applied to cells taken from patient samples—potentially allowing the development of targeted, personalized cellular immunotherapies…”

“Novo picks up California plant from Asterias as it moves stem cell work forward,” FiercePharma

“Novo Nordisk has been gathering a phalanx of assets around a stem cell development program that could cure Type 1 diabetes. Now it has a U.S. manufacturing facility where it can produce them. The diabetes specialist announced today that it will build out a facility in Fremont, California, that it has leased from stem cell biotech Asterias Biotherapeutics. Along with manufacturing intellectual rights it is picking up in the deal, the facility gives Novo a plant that can produce stem cell-based therapies while kick-starting Asterias’ stem-cell program…”

“It’s Flu Season! Genentech’s Investigational Medicine Continues to Show Efficacy,” BioSpace

“New late-stage data released by South San Francisco-based Genentech shows treatment with baloxavir marboxil significantly reduced the time to the improvement of influenza symptoms versus placebo in patients who are at high risk of serious complications from the flu. The Phase III CAPSTONE-2 study is the first late-stage trial to show a clinically meaningful benefit in people who are at high risk for the flu, said Sandra Horning, Genentech’s chief medical officer and head of Global Product Development…”

“Eli Lilly’s diabetes treatment meets main goal in two late-stage studies,” Reuters

“Eli Lilly and Co said on Tuesday its experimental diabetes treatment was shown to be as effective as the drugmaker’s Humalog medicine in two late-stage studies. The study also found that the drug, Ultra Rapid Lispro, significantly improved post-meal blood sugar levels in people with both type 1 and type 2 diabetes and had a similar safety profile as Humalog…”

“Tech breakthrough offers early warning system for heart attacks,” Reuters

“A new method of analyzing images from CT scans can predict which patients are at risk of a heart attack years before it occurs, researchers say. The technology, developed by teams at Oxford University and institutions in Germany and the United States, uses algorithms to examine the fat surrounding coronary arteries as it shows up on computed tomography (CT) heart scans…”