The Dish’s Weekly Biotechnology News Wrap Up – August 25, 2017

By on August 25, 2017

This week’s headlines include: Novartis Speeds New Anti-Malarial as Older Drug Loses Potency, Zika has all but disappeared in the Americas. Why?, Cellectis Starts BPDCN Phase I Trial with Gene-Edited CAR-T Therapy, FDA Offers Draft Guidance to Further Secure Drug Supply Chain, Novartis CEO opens door to cancer patient demanding ‘fair’ CAR-T pricing, and U.S. DOD to Start New Trial with Pluristem’s PLX-R18 Cell Therapy Against ARS.

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

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Efficient Large-Scale Expansion of MSCs for Translational Medicine and Research Use

As part of our ongoing conference coverage of ISSCR 2017, we like to feature posters from the event. One poster covered the very important topic of large-scale expansion of mesenchymal stem cells (MSCs) for both research and translational medicine. The poster, “Expansion of MSCs for Translational Medicine using MSC NutriStem® Basal Medium and PLTMax® Human Platelet Lysate,” was jointly presented by Biological Industries USA and Mill Creek Life Sciences, and highlighted at the Biological Industries booth. In the poster, authors describe the importance of successful large-scale expansion of MSCs and present data on a culture protocol that has generated very successful results…

Continuous suspension cell culture monitoring in bioreactors using quantitative phase imaging

Cell culture monitoring for cell count and cell viability typically involves manual sampling from each bioreactor followed by Trypan-blue cell exclusion. This sampling needs to happen at least once per day and ideally more often. An operator must then enter the results into a spreadsheet or other tracking software and generate a growth curve. The challenge with this process is that it is highly manual, and time consuming. Sampling an entire facility means a whole team is required to monitor what can be upwards of 50+ bioreactors. In addition, manual sampling creates an opportunity for contamination and variability…

Automated Optimization of IgG Production in CHO Cells

An ideal approach to media optimization is using a factorial design of experiment (DOE), where a variety of media components are tested at different concentrations in combination with one another. However, these factorial experiments rapidly increase the number of conditions that require testing. Common ways of quantifying the production of IgG or other proteins are frequently labor intensive (i.e. ELISAs) or prohibitively slow (i.e. HPLC), particularly at the high throughputs required for DOE…

First In-Human Allogeneic Clinical Trial Commences with iPSC-derived Mesenchymal Stem Cells

It is widely accepted that stem cells can be divided broadly into embryonic and non-embryonic stem cells. Embryonic stem cells (ESCs) are derived from the inner cell mass of blastocysts and are pluripotent, meaning they can differentiate into cells of all three germ layers: ectoderm (outer layer), mesoderm (middle layer), and endoderm (inner layer). Conversely, non-embryonic stem cells are found in the extra-embryonic tissues (placenta, umbilical cord blood and amniotic fluid) and in all adult tissues, (i.e. bone marrow, fat, kidney, etc). Human mesenchymal stem cells (hMSCs) are an example of non-embryonic stem cells and were first isolated in the bone marrow and characterized by Friedenstein and his colleagues in 1974 (Amorin, 2014). hMSCs, also called mesenchymal stromal cells, are a subset of non-hematopoietic adult stem cells that originate from the mesoderm (Kim et al, 2013). They are considered to be multipotent; able to self-renew and generate progeny of several distinct cell types…


The Down Stream Column

Bioburden Contamination in Downstream Bioprocesses – Potential entry points for contamination and innovative solutions

Bioburden contamination in biopharmaceutical manufacturing is a big concern. Contamination carries both tremendous cost and preventing it requires strict control of several possible entry points. The cost of bioburden contamination for a company can involve lost time, lost material, batch loss, possible facility closure and extensive QA/QC time to ensure proper cleaning and validation. In the worst case scenario, it can prevent supply of much needed medicine to patients and loss of commercial revenue…

Cool Tool – Achieve Integrated and Scalable Continuous Chromatography

Over the last decade, advances in the upstream processing of monoclonal antibodies (mAbs) has resulted in higher bioreactor titers. With increasing titers, the production bottleneck has shifted to downstream processing. Hence, the biopharmaceutical industry has reached a milestone where the need for higher throughput in downstream processing is leading to the adoption of more efficient multi-column continuous (MCC) counter-current chromatography systems which increase overall productivity while significantly reducing consumables costs…

Continuous bioprocessing – moving from theory to reality

Over the last decade, advances in the upstream processing of monoclonal antibodies (mAbs) has resulted in higher bioreactor titers. With increasing titers, the production bottleneck has shifted to downstream processing. Hence, the biopharmaceutical industry has reached a milestone where the need for higher throughput in downstream processing is leading to the adoption of more efficient multi-column continuous (MCC) counter-current chromatography systems which increase overall productivity while significantly reducing consumables costs…

Impact of Continuous Chromatography Mode on Protein A Resin Lifetime

Traditionally, Protein A chromatography is performed in batch mode using a single, packed column. In batch operations, antibody-containing samples are loaded onto the column at levels well below the total capacity of the resin to prevent sample breakthrough and subsequent product loss. However in recent years, continuous chromatography has emerged as an alternative to batch operations to improve productivity or increase resin capacity utilization of chromatography purification processes. Continuous chromatography by periodic counter-current chromatography (PCC) has been demonstrated to increase utilization of the chromatography resin capacity…

Events:

September

Bioprocess International Conference (BPI East)

September 25-28, 2017
Hynes Convention Center,
Boston, MA

The largest bioprocessing event bringing you the science, technologies and partners needed to accelerate promising biologics towards commercial success. BPI provides the solutions needed to move drug candidates closer to approval.

October

World Vaccine Congress

October 10October 12
CROWNE PLAZA BARCELONA, BARCELONA, Spain

Make sure you are at the forefront of the vaccines industry. No matter where your interest lies, at the 18th annual World Vaccine Congress we have content, networking and potential partners for you.

Speed to IND for Biologics

October 19October 20
Hyatt Centric Fisherman’s Wharf, 555 North Point Street
San Francisco, 94133 United States

With 32 expert presenters, 20 case studies/new data presentations and just two days out of the office, you won’t want to miss this first-of-its-kind event!

November

3rd Annual Cell & Gene Therapy Congress

November 6November 7
immarsat, 99 City Road
London, EC1Y 1AX United Kingdom

Oxford Global Conferences presents its 3rd Annual Cell & Gene Therapy Congress, with our co-located 6th Annual Cell Culture & Bioprocessing Congress and 4th Annual Stem Cell Congress and, 6 – 7 of November 2017, London, UK. View Agenda: bit.ly/2b80uCZ 4 interactive streams: Cell & Gene Therapy: Development & Clinical Trials Cell Therapy Bioprocessing and Manufacturing Presentations will include cell & gene therapy development, updates in regulatory pathways, commercialisation, bioprocessing and manufacturing.

World Orphan Drug Congress Europe

November 13November 15
FAIRMONT REY JUAN CARLOS I, Av. Diagonal, 661-671
BARCELONA, 08028 Spain

The 8th annual World Orphan Drug Congress is the marketplace for orphan drug professionals looking at the complete value chain of orphan drug development, from clinical development and R&D to corporate development and market access.

Headlines:

“Novartis Speeds New Anti-Malarial as Older Drug Loses Potency,” Bloomberg

“Novartis AG began testing a new anti-malaria pill in Africa, advancing development of an alternative to its most effective treatment that billionaire philanthropist Bill Gates said risked losing potency…”

“Zika has all but disappeared in the Americas. Why?,” Science

“One. That is the total number of locally transmitted Zika cases confirmed in the continental United States this year, as of mid-August. That single case, recorded on 26 July in Hidalgo County in Texas, which borders Mexico, contrasts with hundreds of cases of local transmission last year. Better control of Zika’s vector, the Aedes aegypti mosquito that thrives in the hotter, southern part of the country, doesn’t explain the dearth of cases. Nor are other factors such as climate change at work, experts say. Instead, Zika cases have plummeted in Latin America and the Caribbean, where the virus raged over the past 2 years, and much of the population is now immune to it. That, in turn, means fewer infected people entering the United States, reducing the chances of mosquitoes spreading the virus to susceptible people. The respite, experts say, could last for years…”

“Cellectis Starts BPDCN Phase I Trial with Gene-Edited CAR-T Therapy,” Genetic Engineering News

“Cellectis reported that the first patient has been dosed in a Phase I clinical trial evaluating its TALEN® gene-edited chimeric antigen receptor (CAR) T-cell product UCART123 in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The BPDCN study follows on from the start in June of a Phase I study to evaluate the safety and efficacy of UCART123 in patients with acute myeloid leukemia (AML). Cellectis  says UCART123 is the first allogeneic, off-the-shelf, gene-edited CAR T-cell program targeting CD123 to enter clinical trials in the U.S…”

“FDA Offers Draft Guidance to Further Secure Drug Supply Chain,” Regulatory Focus

“The US Food and Drug Administration (FDA) has released draft guidance ahead of the first of a series of public meetings to help companies meet the drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) of 2013…”

“Novartis CEO opens door to cancer patient demanding ‘fair’ CAR-T pricing,” FiercePharma

“David Mitchell had just finished a five-hour infusion of drugs to keep his multiple myeloma under control when he decided to dash off a letter to Joe Jimenez, CEO of Novartis, requesting a meeting about how the company plans to price tisagenlecleucel (CTL019), its CAR-T leukemia treatment expected to win approval from the FDA in October…”

“U.S. DOD to Start New Trial with Pluristem’s PLX-R18 Cell Therapy Against ARS,” Genetic Engineering News

“The U.S. Department of Defense’s (DOD) Armed Forces Radiobiology Research Institute (AFRRI) is to undertake a pilot study in nonhuman primates (NHP) evaluating Pluristem Therapeutics’ PLX-R18 as a treatment for acute radiation syndrome (ARS) prior to and within the first 24 hours of radiation exposure. The AFRRI is part of the Uniformed Services University of Health Sciences (USUHS)…”

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