This week’s headlines include: World’s First Commercial iPSC Cell Plant Opens in Japan, Fujifilm Acquiring Irvine Scientific, IS Japan for $800M, with Cell Culture Media Growth in Mind, Pfizer’s rare heart disease drug succeeds in late-stage study, Bluebird, Celgene to share U.S. costs, profits on lead cancer CAR-T, FDA working on a ‘dozen’ policies to boost copycat biotech drugs, and AI. Telemedicine. Quantum. New Novartis Boss Says Tech Will Finally Change The Drug Biz.

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

Significant Growth Expected for Stem Cell Manufacturing Market

The market outlook has proven favorable for regenerative medicines as well as genetically modified Cell Therapy products. The role of stem cells has grown vastly; various stem cell lines are being evaluated by life science researchers for use in effective disease management and biological studies. This trend has provided a lucrative growth opportunity for cell line manufacturers offering specific stem cell lines and related products…

Cell Therapy Manufacturing – Opportunities and Challenges

In this podcast and accompanying we interviewed Dr. Robert Preti about the past, present and future of global Cell Therapy manufacturing. We also discussed major industry milestones, manufacturing challenges and opportunities for the further improvements…

Use of Recombinant Proteins to Create a Blood-free Media Formulation – A Discussion

We recently finished our Ask the Expert discussion, “Incorporating recombinant proteins to produce blood-free media formulations for therapeutic cell types”. During this Ask the Expert session, we discussed transitioning cells to blood free formulations, cell health and growth in blood-free medium and associated benefits…

Video Series – Maintaining Bioprocess Validation

Bioprocess validation is not only a regulatory requirement, it is also a key component in ensuring the quality and efficiency of a biomanufacturing platform. This week’s Two Minute Tuesday educational video is the first in a four part series of interviews with Dr. Shawn Latham, Validation Manager at Shire Plc. In this video Shawn is interviewed on maintaining validation in biomanufacturing. He discusses how during filing for licensure you must prove that your process claims are true and then you must maintain that those claims are true over time. As time passes, equipment and processes may drift and so based on risk based assessments, validation measures must be established. High risk areas must be validated more frequently…

Integrating Downstream Unit Operations – Polishing and Concentration Steps

Most downstream biomanufacturing process steps are conducted as separate unit operations. As such, there are a great number of manual tasks including individual instrument function, intermediate handling of material, and product transfer. This high reliance on manual tasks consumes more resources and introduces greater opportunity for operator error…

Global Downstream Bioprocessing Market Expected to Demonstrate Significant Growth

Downstream bioprocessing involves a number of products such as chromatography columns and resins, filters, membrane adsorbers, single-use products, and other products (consumables and instruments). Columns and resins are the most important components of a chromatography system and are extensively used in the separation, recovery, and purification of components of a bioactive sample. In addition, different samples in the drug development phase require different types of columns for separation, and these columns have to be frequently changed to optimize the stationary phase. Also, for the purpose of purification, resins need to be repurchased…

Continuous Biomanufacturing Implementation Now and in the Future

In this podcast and accompanying article, we interviewed Dr. Peter Levison, Senior Marketing Director – Downstream Processing, Pall Biotech about the evolution and benefits of continuous biomanufacturing, what implementation looks like today and what still needs to be realized for full industry adoption…

Validation of Virus Filtration in Continuous Bioprocessing

Adoption of continuous processes certainly seems on the biomanufacturing horizon and this is not surprising considering the benefits of an integrated continuous approach. Demonstrated benefits include operational flexibility and efficiency, product consistency, increased quality assurance, and cost savings. However moving toward continuous bioprocessing requires the development of enabling technologies to support this type of operation…

Conferences:

Stem Cell Community Day

The second international Stem Cell Community Day will take place on April 24, 2018 in Duesseldorf, Germany. The event brings together experts from industry and academia to discuss recent trends, achievements, and challenges in bioprocessing technologies for Stem Cell Research. The conference is organized by leading life science company Eppendorf AG. In three sessions, the participants will discuss ways for establishing robust stem cell culture protocols, process strategies for obtaining commercial cell quantities, and challenges related to product purity. Professor Joaquim M. S. Cabral from the University of Lisbon will chair the conference. Dr. Robert Zweigerdt from Hannover Medical School and Karen Coopman, PhD from Loughborough University will present their latest findings in keynote lectures. For more information, please see www.stemcellday.de

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:

“World’s First Commercial iPSC Cell Plant Opens in Japan,” The Scientist

“A pharmaceutical company based in Osaka, Japan, opened a regenerative medicine center yesterday (March 22) that will produce cells derived from induced pluripotent stem (iPS) cells for commercial applications. The center is the first plant of its kind globally. It will initially produce cells for use in clinical trials…”

“Fujifilm said today it intends to expand its ability to develop and manufacture biopharmaceuticals and regenerative medicine treatments by acquiring a pair of cell culture media businesses owned by Japan-based JXTG Holdings for a combined $800 million. Fujifilm plans to acquire all outstanding shares of Irvine Scientific (ISUS) and IS Japan (ISJ) and incorporate the businesses into its existing contract development manufacturing organization (CDMO) unit Fujifilm Diosynth Biotechnologies…”

“Pfizer’s rare heart disease drug succeeds in late-stage study,” Reuters

“Pfizer Inc’s experimental drug to treat a rare and fatal disease linked to heart failure reduced deaths and need for hospitalizations in a late-stage study…

“Bluebird, Celgene to share U.S. costs, profits on lead cancer CAR-T,” FierceBiotech

“Bluebird bio has pulled the trigger on an option to co-develop and co-promote the anti-BCMA CAR-T treatment, bb2121, with Celgene in the U.S. The move comes two years after Celgene forked over $10 million to exclusively license the therapy…”

“FDA working on a ‘dozen’ policies to boost copycat biotech drugs,” Reuters

“The U.S. Food & Drug Administration is working on around a dozen actions to boost use of cheaper versions of expensive biotech medicines, the head of the agency Scott Gottlieb said on Wednesday…”

“AI. Telemedicine. Quantum. New Novartis Boss Says Tech Will Finally Change The Drug Biz,” Forbes

“What does the youngest chief executive in Big Pharma want? A control room straight off the starship Enterprise. When Vas Narasimhan, 41, took the helm of drug giant Novartis in February, he’d already put the project in motion. Novartis scouts were dispatched to visit air traffic control towers and the Swiss electrical grid to see how other industries dealt with torrents of data. Working with McKinsey’s QuantumBlack unit, they built a software system called Nerve that not only keeps track of every data point on all 550 clinical trials testing Novartis drugs, but also uses analytic software to predict potential hiccups in the execution of those studies. Soon Narasimhan will be able to walk into mission control at the company’s Basel, Switzerland, headquarters and call up whatever information he needs in an instant…”