The Dish’s Weekly Biotechnology News Wrap Up – August 16, 2019

This week’s headlines include: Presidential candidates should take bus trip of hope not fear, Regeneron’s Ebola treatment proves superior to rival in trial, Nucleus Biologics acquires Primorigen Biosciences, gains proprietary, high yield, recombinant protein platform, Medicare to cover expensive cancer cell therapies, and International Regulators Call for Action on Antimicrobial Resistance.

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

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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…

Biopharmaceutical Manufacturing and Single-Use Technologies 2019 Meeting in Review

In July the small town of Wädenswil, Switzerland saw suppliers, manufacturers and academics meet at Biotech 2019, the fifth meeting on the topic of “Biopharmaceutical manufacturing and Single-Use Technologies”. This year’s theme, “Process intensification and continuous bioprocessing with single-use devices”, proved to be both timely and popular. The experienced organizers scheduled a comprehensive agenda of oral presentations, poster exhibitions, industrial workshops and panel discussions…

Semi-automated Closed CAR-T Manufacturing Process

CAR-T cell-based gene therapy technology is one of the most exciting new medical developments, with two of the most popular examples being the cancer immunotherapies Kymriah® and Yescarta®. These cell-based gene therapies have been able to provide unprecedented remission rates and have demonstrated success where other therapies have failed…

Mustang Bio’s gene therapy has tremendous potential to cure X-SCID or Bubble Boy Disease based on study results from St. Jude

In this podcast, we interviewed Dr. Manny Litchman, President and CEO, Mustang Bio and Dr. Knut Niss, Chief Technology Officer, Mustang Bio about the exciting study results for their gene therapy candidate to treat X-SCID, why this disease is a good fit for gene therapy and next steps…

In-Process Analytical Methods are Critical in Gene Therapy Development

In gene therapy manufacturing, evaluating viral vector stability and integrity is critical in process development prior to production scale up. Process changes can affect critical quality attributes and as a result any process changes need to be carefully evaluated to determine the impact on viral particle size and intactness to ensure final product quality…


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:

“Presidential candidates should take bus trip of hope not fear,” The Hill

With cameras rolling in the run-up to the Democratic presidential primary debates, Sen. Bernie Sanders (I-Vt.) loaded a dozen patients on a bus for a campaign stunt across our country’s northern border to highlight insulin prices in Canada. At a pharmacy in Windsor, Sanders didn’t reference the middlemen feeding at the trough of high drug prices. He said nothing about the pharmacy benefit managers hording rebate checks or insurers drowning patients in denials and paperwork until they stop taking the medicines they need.

“Regeneron’s Ebola treatment proves superior to rival in trial,” Reuters

“Regeneron Pharmaceuticals Inc said on Monday its experimental treatment for Ebola proved superior to a rival therapy from Mapp Biopharmaceutical at preventing death, in a trial evaluating four treatments for infections caused by the deadly virus. The company said the trial was ended early because its therapy, REGN-EB3, elicited a “highly statistically significant result” compared to Mapp’s ZMapp, which was considered a standard-of-care treatment…”

“Nucleus Biologics acquires Primorigen Biosciences, gains proprietary, high yield, recombinant protein platform, PR Newswire

“Nucleus Biologics, a leader in precision cell culture, is pleased to announce the acquisition of Primorigen Biosciences, Inc. The addition of Primorigen’s Vitronectin XF™ and platform recombinant protein production technology will play a huge role in Nucleus’ strategy of offering traceable, reproducible and xeno-free (XF) cell culture ecosystems for the cell and gene therapy space…”

“Medicare to cover expensive cancer cell therapies,” Reuters

“The U.S. Centers for Medicare and Medicaid Services (CMS) on Wednesday said it has finalized a decision to cover expensive cancer cell therapies sold by Gilead Sciences Inc (GILD.O) and Novartis AG (NOVN.S). CMS, which runs Medicare – the federal government’s health plan for Americans 65 and older – said it will cover the U.S. Food and Drug Administration-approved therapies when provided in healthcare facilities that have programs in place to track patient outcomes…”

“International Regulators Call for Action on Antimicrobial Resistance,” Regulatory Focus

“The International Coalition of Medicines Regulatory Authorities (ICMRA) on Thursday issued a statement calling on industry, healthcare practitioners, researchers and other global health leaders to address the growing threat of antimicrobial resistance (AMR)…”