This week’s headlines include: Kite executives are back with a CAR-T startup, $300M and Pfizer drugs, ReForm Biologics and KBI Biopharma Announce Strategic Partnership to Improve Biopharmaceutical Formulations and Development, CRISPR Use Could Lead to “Organic” Gene Therapies for Blood Disorders, WuXi AppTec gets fast-track approval for $900M-plus Shanghai IPO, and AbbVie, Samsung Bioepis in deal; Humira biosimilar U.S. release in 2023.

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…

Flexible Downstream Platform Facilitates Adaptation to Scale

In biomanufacturing, upstream titers are increasing as new cell lines and technologies are being developed. This puts pressure on downstream processes, especially the capture step…

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…

Webinar:

Automated Analysis of Purity and Packaging of Gene Therapy Vectors and VLPs Using Transmission Electron Microscopy (TEM)

Wednesday, April 11, 2018 at 11:00 AM Eastern Daylight Time

The characterization of morphological features of viral particles such as Gene Therapy vectors and virus-like particles (VLPs) used in influenza vaccine give powerful data to base decisions on during process development.

In this webcast, experts in transmission electron microscopy (TEM)-based analysis of viral particles will explain why cryoTEM methods should be used to determine the portion of empty viral capsids resulting from failure in packaging the genetic material; whereas negative nsTEM is the method of choice to determine empty and broken viral particles resulting from structural changes of the capsid along the manufacturing process. Being able to distinguish between these morphological characteristics helps to improve the potency of the drug and avoid safety issues as viral particles with damaged capsids have higher tendency to provoke immunogenicity issues.

The webcast will also cover how TEM technology can be used to understand the impact of process parameters on the quality of influenza VLPs used in vaccine development.

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:

“Kite executives are back with a CAR-T startup, $300M and Pfizer drugs,” FierceBiotech

“They created the first CAR-T for non-Hodgkin lymphoma, and now they’re working on the next chapter. Former Kite Pharma executives Arie Belldegrun and David Chang are helming Allogene Therapeutics, which starts life with a massive $300 million series A round and 17 off-the-shelf CAR-T assets licensed from Pfizer…”

“ReForm Biologics and KBI Biopharma, Inc., (KBI) today announced a strategic partnership to make improved biopharmaceutical formulations. Through this collaboration, KBI and ReForm will help customers extend product lifecycles, enable improved dosing for patients, and enhance manufacturing efficiencies. As part of the strategic partnership, KBI has made an equity investment in ReForm Biologics…”

“CRISPR Use Could Lead to “Organic” Gene Therapies for Blood Disorders,” Genetic Engineering News

“Scientists in Australia have solved a 50-year-old mystery that could lead to the development of new gene therapies for blood disorders such as sickle cell anemia and β-thalassemia. The team, led by University of New South Wales (UNSW) professor Merlin Crossley, Ph.D., has identified the gene-control mechanism that allows some individuals with these blood disorders to keep producing a fetal form of human hemoglobin, which naturally compensates for the lack of adult hemoglobin and so reduces disease severity. The researchers also used CRISPR/Cas9 gene editing to introduce these naturally beneficial mutations into cultured blood cells and boost production of fetal hemoglobin directly…”

“WuXi AppTec gets fast-track approval for $900M-plus Shanghai IPO,” FierceBiotech

“WuXi AppTec has received approval from the Chinese stock regulatory body to relist on Shanghai Stock Exchange through an IPO, less than two months after the CRO giant submitted its revised prospectus…”

“AbbVie, Samsung Bioepis in deal; Humira biosimilar U.S. release in 2023,” Reuters

“AbbVie Inc on Thursday said it signed a deal with Samsung Bioepis and its joint venture partner Biogen Inc that would fend off U.S. competition of their biosimilar version to blockbuster drug Humira until 2023…”