Weekly Biotechnology News Wrap Up – August 30, 2019

This week’s headlines include: AstraZeneca respiratory business gets boost from three-drug inhaler results, Alliance Task Force Joins Consensus against Germline Gene Editing, Ionis Gets $25M From GSK for Experimental Hepatitis B Program, GSK builds oncology pipeline as drug shown to help myeloma patients, Organoids Are Not Brains. How Are They Making Brain Waves? and Laser-charged gold nanoparticles destroy prostate tumors in first-in-human study.

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

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New Flexible Bispecific Antibody Format Demonstrates Improved Therapeutic Properties and Manufacturability

This year’s Next Generation Protein Therapeutics & Bioconjugates™ Summit held in San Francisco provided an in-depth look at the latest developments in next-generation protein therapeutic discovery and manufacturing. One talk that I found of particular interest was, “WuXiBody,™ an Innovative and Versatile Bispecific Antibody Format, Opens a New Era For Therapeutic Antibody Development,” presented by George Wang, Ph.D., MBA, Vice President of Biologics Discovery, WuXi Biologics. The talk provided an excellent overview of the promise of bispecific antibodies as well as the associated challenges. Dr. Wang also shared an innovative bispecific antibody platform designed to address many current platform shortcomings…

Using transposases to generate clones with high, predictable expression and stability

Standard cell line development workflows include transfection followed by the screening of hundreds to thousands of clones, in an effort to find high producing clonal colonies that are stable and demonstrate specific attributes based on the product specifications. Some approaches at the clone isolation stage utilize in-situ fluorescence detection to try and pull out up front the best protein secretors. I am pleased to share the following guest blog that presents an alternative solution to ensure isolation of the high producing clones – transposases. I was fortunate enough to be able to interview the author about his article and have provided the transcript of our conversation following the guest blog…

Next Generation CAR & T Cell Therapies Conference Overview

This year was the initiation of the Next Generation CAR & T Cell Therapies conference, held in conjunction with the Next Generation Protein Therapeutics & Bioconjugates™ Summit and Cell Line Development & Engineering US event. With CAR & T cell therapies generating so much excitement for liquid cancer malignancies, many researchers are looking to this immunotherapy for solid tumors and also to broaden the scope of current CAR-T therapies by moving in an allogeneic direction. As the field matures, it is also evident that dialing in the CAR-T manufacturing process by incorporating PAT (process analytical technology) will be necessary to reduce costs and capitalize on novel analytical capabilities and equipment. This is by no means exhaustive coverage of the conference, but provides talk highlights on strategies to address key issues…

Cool Tool – Quantitative LC-MS Solution for Targeted Analysis of Cell Culture Media

Cell culture media optimization is a critical aspect of process development. To ensure the best manufacturing productivity and final product quality, media components must be carefully evaluated. In the last decade, the biopharmaceutical industry has developed a greater understanding of individual medium components and their profound impact, not just on how much titer can be achieved, but also on the quality and efficacy of the final product. In order to better understand how each of these components affects critical quality attributes, it is important to conduct a thorough cell culture media analysis…

Qualifying a rapid qPCR mycoplasma test approved for CAR-T clinical studies

Like other biologics, most cell therapy products require microbial testing including, mycoplasma, sterility, and endotoxin analysis as part of the final product release criteria. However, cell therapy products have unique QC product release requirements that necessitate new microbial testing technologies to support these unique needs. One of these is that since the cells are the final product so they cannot be put through a final sterile filtration step or undergo a harsh sterilization step and have a limited shelf life. As a result, it is a critical to implement rapid microbial testing for in-process and final product release that are compliant with the stringent regulatory requirements and also meets the unique QC needs for cell therapy products. Traditional testing methods for mycoplasma, sterility and endotoxin can take several weeks to over a month and require a large amount of sample volume which doesn’t fit the needs of limited sample availability and quick turnaround time for cell therapies. This is why rapid microbial methods, including rapid PCR mycoplasma methods, provide an important solution to a significant challenge in cell therapy quality management…

Technologies for Cell and Gene Therapy Manufacturing – A Summary of Cell and Gene Therapy Week

Last week we celebrated cell and gene therapy with an entire week of cell and gene therapy related articles. In case you missed it, I’ve highlighted the articles here along with some of our favorite cell and gene therapy pieces from this year…


The Down Stream Column

Bioburden Control Strategies for Continuous Downstream Processing

Implementing continuous bioprocessing for biomanufacturing has been increasing in interest. As a result, questions have arisen about the implementation of this strategy for downstream processes. Of particular interest is maintaining a high degree of bioburden control in continuous downstream process. While bioburden control strategies for continuous processing focus on prevention, not unlike batch processing, many want to know if there are specific strategies that should be implemented with continuous bioprocessing that are different than those used in batch processing…

Cool Tool – Innovative sorbents enable a robust and streamlined protein purification process

Monoclonal antibodies have long been purified using a platform approach. This platform mainly consists of three chromatography steps. These include a Protein A based affinity chromatography step followed by polishing steps. The purpose of the affinity chromatography is to capture the mAb, while the polishing steps remove any remaining impurities, such as residual DNA, host cell proteins, viruses and aggregates. There are options in the selected polishing steps, but often they involve cation exchange or hydrophobic interaction. Increasingly membrane chromatography is being used as a polishing step to remove any remaining contaminants…

Optimizing mAb Purification with Highly Selective Mixed-mode Cation Exchange Sorbent

In today’s market, mAbs are produced for several therapeutic applications, yet they are not a homogeneous family of products. Each mAb is unique, based on its isoelectric point, hydrophobicity and ability to aggregate; the contaminant HCP content is also process-dependent. As drug manufacturers seek to produce mAbs for various application, they are also looking to streamline processes for efficiency and quality…

Scalable Protein A Chromatography for High-Throughput Process Development

Process development is a critical part of biomanufacturing, but it can be very time and resource intensive. With recent industry initiatives around speed to market, process development is an area that could really benefit from high throughput solutions. One high-throughput process development tool for chromatography is the use of 96-well plates. These plate platforms permit automated screening of large numbers of conditions very efficiently and use only a small amount of material for testing. This platform is great for screening but requires bridging experiments to translate results to process scale. In addition, automating the 96-well process requires investment in liquid handling equipment in order to reach the full potential of the platform…

Utilizing High-Throughput Process Development Tools to Create a Purification Process for a Biosimilar Molecule

Biosimilar molecules have some unique manufacturing requirements that must be taken into account when planning process development. The requirements for process development typically require a good deal of selectivity, cost-efficiency and the need to meet aggressive timelines. These lend themselves to a process development approach that incorporates high throughput…


Conferences:

World ADC San Diego

October 8October 11
Grand Hyatt San Diego, 1 Market Place
San Diego,CA92101United States
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World ADC San Diego

With the next ADC approval in touching distance, the ADC field is on the edge of their seats to hear when the next exciting announcement will be. With new collaborations and important results constantly being shared, it’s safe to say the field is ever-evolving. However, despite the excitement we continue to face roadblocks with off-target toxicity, ensuring a robust supply chain and maximizing the clinical therapeutic window of an ADCs. Designed with Pfizer, Seattle Genetics, Genentech and ImmunoGen this leading…

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Headlines:

“AstraZeneca respiratory business gets boost from three-drug inhaler results,” Reuters

“Prospects for AstraZeneca’s (AZN.L) respiratory treatments business improved on Wednesday as a three-drug inhaler was shown to ease smoker’s lung and U.S. regulators granted its injectable asthma drug Fasenra special status for a rare lung condition…”

“Alliance Task Force Joins Consensus against Germline Gene Editing,” Genetic Engineering News

“A task force of the Alliance for Regenerative Medicine (ARM) consisting of gene-editing therapy developers today sided with the emerging scientific consensus against germline gene editing in human clinical research without coming to terms with legal, ethical, and other implications—part of a statement intended to articulate a bioethical framework for use of the technology in therapeutic applications…”

“Ionis Gets $25M From GSK for Experimental Hepatitis B Program,” Xconomy

“Ionis Pharmaceuticals (NASDAQ: IONS) has a pipeline of two drugs that the biotech says target the root cause of liver disease associated with chronic hepatitis B. (The condition is considered chronic if patients test positive for more than six months). The drugs are designed to reduce the production of viral proteins associated with such infections, including hepatitis B surface antigen, which, if discovered in a blood test, is an early sign of infection…”

“GSK builds oncology pipeline as drug shown to help myeloma patients,” Reuters

“GlaxoSmithKline said an experimental multiple myeloma treatment has shown a meaningful response in patients that have run out of three previous treatment options, in a boost for the British drugmaker’s cancer drug business…”

“Clusters of living brain cells are teaching scientists about diseases like autism. With a new finding, some experts wonder if these organoids may become too much like the real thing…”

“Laser-charged gold nanoparticles destroy prostate tumors in first-in-human study,” Fierce Biotech

“By saturating cancerous tissues with nanoparticles that covert light into heat—tiny shells, made of gold and silicon—clinicians were able to destroy prostate tumors with laser precision in a first-in-human trial. After one year, 14 out of the 16 treated lesions tested negative for signs of cancer, according to procedure developer Nanospectra Biosciences…”