The Dish’s Weekly Biotechnology Wrap Up – August 23, 2019

This week’s headlines include: Pfizer Invests $500 Million in Gene Therapy Manufacturing Plant, WuXi builds revenues, capacity as competition boils among Asian CDMOs, Moderna stock pops after Zika vaccine gets FDA fast track, Roche’s personalized cancer treatment wins FDA approval, Developing New Guidelines on Lyme Disease, and A Spoonful of Charcoal Helps the Antiviral Go Down.

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

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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…

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…


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
+ Google Map
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:

“Pfizer Invests $500 Million in Gene Therapy Manufacturing Plant,” Bloomberg

“Pfizer Inc. said it plans to spend $500 million to expand a gene-therapy manufacturing facility in Sanford, North Carolina, helping the drug giant scale up production of treatments that fix faulty strands of DNA…”

“WuXi builds revenues, capacity as competition boils among Asian CDMOs,” FiercePharma

“WuXi Biologics expects to have a plant in Europe complete in 2021 as a capacity race plays out among Asia’s rapidly growing biologics CDMOs. The Chinese company also insists its vaccine partnership will complete a multibillion-dollar contract by year-end with a dedicated plant to follow, but has yet to identify with whom the deal was struck…”

“Moderna stock pops after Zika vaccine gets FDA fast track,” Market Watch

“Shares in Moderna Inc. MRNA, -0.91% jumped 7% in extended trading Monday, after the company announced that the Food and Drug Administration had approved its potential vaccine for the Zika virus for a fast track to approval. Zika, a disease spread by mosquitoes, spread in 2016, and many companies are attempting to develop vaccines to the disease. Moderna’s attempt at a vaccine is currently in a Phase 1 study, and is being especially targeted to avoiding transmission of the disease from a mother to an unborn child…”

“Roche’s personalized cancer treatment wins FDA approval,” Reuters

“The U.S. Food and Drug Administration approved Roche Holding AG’s personalized cancer treatment, which targets tumors with specific genetic mutations, irrespective of where in the body the disease started, the agency said on Thursday. The treatment, Rozlytrek, is a tyrosine kinase inhibitor that targets patients who must be identified via genetic profiling. It is approved to treat certain types of solid tumors, which show rare genetic anomalies called NTRK fusions…”

“Public comments are still being accepted, but antibiotic treatment options for children are likely to be expanded to include the use of doxycycline…”

“A Spoonful of Charcoal Helps the Antiviral Go Down,” Genetic Engineering News

“There was a time in medicinal history when activated charcoal was considered the universal antidote. Since then it has been touted to reduce flatulence, prevent hangovers, and lower cholesterol. Its effectiveness at neutralizing ingested poisons or medication overdoses is well established, but less so is activated charcoal’s ability to increase the efficacy of certain drugs. Now, investigators at the University of Illinois at Chicago have found that combining acyclovir—a commonly prescribed topical herpes medication—with particles of activated carbon improves the drug’s effectiveness…”