The Dish’s Weekly Biotechnology News Wrap Up – August 18, 2017
This week’s headlines include: Scientists report progress on “liquid biopsies” for cancer screening, FDA approves Pfizer’s drug for rare blood cancer, Takeda R&D reboot continues with Stanford drug discovery deal, MilliporeSigma to Be Granted European Patent for CRISPR Technology, and Amgen falls short in Epogen patent appeal but Pfizer stumble delays competition.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
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…
In-line Viral Load Measurement using Smart Cell Culture Monitoring
Smart in-line cell culture monitoring as an efficient way to measure viral load in real-time. This kind of real-time measurement is only possible with the iLine F. The iLineF is an innovative microscopy technology that instead of taking a 2D image of a microscopic object, takes a hologram of a microscopic volume. Then for each microscopic object within the culture volume, it can compute a holographic fingerprint. This fingerprint can then be used to analyze, identify, count and assess viability of cells in culture…
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…
Fine Tuning Viral Clearance Approaches with a Total Viral Challenge Strategy
In this mini-webinar, Michael Burnham, M.S., Senior Principal Scientist, Process Development and Commercialization, WuXi AppTec, presents a viral clearance strategy that focuses on spiking load or starting material based on total viral load instead of percent spike model…
Events:
August
The Bioprocessing Summit convenes more than 1,000 international bioprocess professionals to share practical solutions for today’s bioprocess challenges. Now in its ninth year, the event has grown to include 18 distinct conferences with weeklong programming on upstream and downstream processing, analytical development and quality, formulation and stability, cell and Gene Therapy production, and manufacturing. Along with the impressive array of conferences, the Summit also includes short courses and training seminars that provide in-depth coverage of critical bioprocess topics.
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
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.
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
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
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:
“Scientists report progress on “liquid biopsies” for cancer screening,” CBS News
“Scientists have the first major evidence that blood tests called liquid biopsies hold promise for screening people for cancer. Hong Kong doctors tried it for a type of head and neck cancer, and boosted early detection and one measure of survival. The tests detect DNA that tumors shed into the blood. Some are used now to monitor cancer patients, and many companies are trying to develop versions of these for screening, as possible alternatives to mammograms, colonoscopies and other such tests. The new study shows this approach can work, at least for this one form of cancer and in a country where it’s common…”
“FDA approves Pfizer’s drug for rare blood cancer,” Reuters
“The U.S. Food and Drug Administration (FDA) said on Thursday it approved Pfizer Inc’s rare blood cancer drug, Besponsa, with a boxed warning. A boxed warning is the agency’s severest form of warning reserved to caution against the most serious side effects. Besponsa was approved to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), a disease that will affect about 5,970 people in the United States this year and kill about 1,440, according to the National Cancer Institute…”
“Takeda R&D reboot continues with Stanford drug discovery deal,” Fierce Biotech
“Takeda’s R&D shake-up continues to rumble on, with the Japanese drugmaker signing a wide-ranging deal that will see it work closely with researchers at Stanford University. Like most drugmakers, Takeda has long been extolling the virtues of forging closer links with academic research teams, and the new three-year agreement—to create the Stanford Alliance for Innovative Medicines—firms up that strategy…”
“MilliporeSigma to Be Granted European Patent for CRISPR Technology,” Genetic Engineering News
“The European Patent Office (EPO) has told MilliporeSigma it intends to grant approval of its patent application covering the company’s CRISPR technology used in a genomic integration method for eukaryotic cells—the second key patent awarded in Europe covering the gene-editing technology…”
“Amgen falls short in Epogen patent appeal but Pfizer stumble delays competition,” Fierce Pharma
“With a federal appeals decision handed down this week, Amgen has come up short in a legal attempt to defend blockbuster anemia med Epogen from a Pfizer biosim. However, the company’s loss in appeals doesn’t mean its drug will face cheap competition right away…”